Trial Design Model

[1 Introduction 2](#introduction)

[1.1 Changes in Version 2 2](#changes-in-version-2)

[1.2 Additions in Version 2 3](#additions-in-version-2)

[1.2.1 Activity Definition Datasets 3](#activity-definition-datasets)

[1.2.2 Mechanisms for Describing Timings
4](#mechanisms-for-describing-timings)

[1.2.3 Conditions on Activities 5](#conditions-on-activities)

[2 The Trial State Machine 7](#the-trial-state-machine)

[2.1 The Trial State Machine 7](#the-trial-state-machine-1)

[2.2 Trial Elements 9](#trial-elements)

[2.3 Trial Arm Segments 11](#trial-arm-segments)

[2.4 Trial Arms 13](#trial-arms)

[3 Activity Definition Datasets 14](#activity-definition-datasets-1)

[3.1 Defining Activities 14](#defining-activities)

[3.2 Grouping Activities 15](#grouping-activities)

[3.3 Planned Activities 15](#planned-activities)

[3.4 Planned Regimens 18](#planned-regimens)

[3.5 Evaluation Intervals and Windows
20](#evaluation-intervals-and-windows)

[4 Trial Activities 22](#trial-activities)

[4.1 Vocabulary for Trial Timings 22](#vocabulary-for-trial-timings)

[4.2 Trial Activities Dataset 26](#trial-activities-dataset)

[4.3 Examples of Records in Trial Activities Dataset
28](#examples-of-records-in-trial-activities-dataset)

[4.4 Trial Visits 30](#trial-visits)

[4.5 Visit Groups 31](#visit-groups)

[4.6 Trial Windows 32](#trial-windows)

[4.7 Trial Anchors 33](#trial-anchors)

[4.8 Offset groups 34](#offset-groups)

[4.9 Periodic Offset Group 35](#periodic-offset-group)

[4.10 Periodic Anchor Groups 36](#periodic-anchor-groups)

[5 General Issues 38](#general-issues)

[6 Feedback 38](#feedback)

# Introduction

## Changes in Version 2

This version of the Trial Design Model provides functionality for
describing trials with dissimilar arms. Version 1 suggested that Epochs
might not be defined for such trials, but the issue has been resolved by
allowing the insertion of Trial Arm Segments between Trial Elements and
Trial Arms.

For many trials, including blinded trials, the elements in each Arm form
a similar pattern, and the trial can be described with a matrix whose
rows are Arms, whose columns are Epochs, with each cell containing one
Element, as in the following example.

  -------- ----------- ----------- -------- ----------- -------- ----------- -----------
           Screening   First       First    Second      Second   Third       Follow-up
           Epoch       Treatment   Rest     Treatment   Rest     Treatment   Epoch
                       Epoch       Epoch    Epoch       Epoch    Epoch       

  P-5-10   Screen      Placebo     Rest     5 mg        Rest     10 mg       Follow-up
  Arm                                                                        

  5-P-10   Screen      5 mg        Rest     Placebo     Rest     10 mg       Follow-up
  Arm                                                                        

  5-10-P   Screen      5 mg        Rest     10 mg       Rest     Placebo     Follow-up
  Arm                                                                        
  -------- ----------- ----------- -------- ----------- -------- ----------- -----------

A Trial Arm Segment is a sequence of Elements which fits in an Arm/Epoch
cell, as in the following example, where the Treatment Epoch consists of
three Elements for one Arm, but only one Element for the other Arm.

  ----------- ----------- --------------- ----------- ---------------- -----------
              Screening   Treatment Epoch                              Follow-up
              Epoch                                                    Epoch

  Surgery Arm Screen      Pre-Operative   Surgery     Post-Operative   Follow-up

  Drug Arm    Screen      Drug                                         Follow-up
  ----------- ----------- --------------- ----------- ---------------- -----------

The addition of Trial Arm Segments also allows for more graceful
treatment of oncology trials or other trials with cycles of treatment.

## Additions in Version 2

This version of the Trial Design Model adds functionality to describe
the scheduling of Trial Activities. This information is typically
represented in current protocols by means of a table called \"Schedule
of Activities\" or \"Time and Events Table\" whose columns are timings
(typically Visits) and whose rows are activities such as assessments,
interventions, and administrative actions (obtaining informed consent,
dispensing clinical trial material, reviewing diaries, etc.).

This model describes the scheduling of Trial Activities by means of a
dataset with three main sections:

-   A variable that names **what** activity is to be performed or what
    unplanned things (e.g., AEs, con meds) are to be recorded.

-   Variables that describe **when** the activities are to be performed
    and when to watch for unplanned things.

-   A variable that describes **whether** an activity is to be performed
    or data is to be collected.

### Activity Definition Datasets

The \"**what\"** variable contains an activity name which is defined in
one of two datasets:

-   Planned Activities. This dataset defines activities, and also define
    groups of activities. Activities may include

    -   Performing tests or examinations that will result in the
        collection of data that will be stored in SDTM Findings
        datasets.

    -   Administering interventions planned in the protocol. Data on
        these interventions will be stored in SDTM Interventions
        datasets such as Expsoure.

    -   Recording data about unscheduled interventions. These data will
        be stored in SDTM Interventions datasets such as Con Meds.

    -   Recording data about events, which will be stored in SDTM Events
        datasets.

    -   Administrative actions that may not result in any data
        collection, or will result in data stored in an SDTM Events
        dataset such as Disposition.

> Groups of activities may be defined and named. The activities within a
> group may have a defined order (e.g., the questions within a validated
> questionnaire) or not (e.g., the lab tests to be performed on a blood
> sample or the individual findings that result from an ECG).

-   Planned Regimens defines groups of activities which must be
    performed according to a certain schedule, with certain times
    between activities, not just in a particular order. The Planned
    Regimens dataset is optional. The scheduling of certain related
    groups of activities may be defined in the Trial Activities table,
    without use of the Planned Regimens table. However, if a group of
    activities will be performed to the same schedule at multiple times
    during the trial, the Planned Regimens dataset provides a convenient
    mechanism for handling this repetition.

Trial Activities are identified with a Domain, with a Topic Variable
value (TESTCD is required for findings, but not all Interventions
require TRT and not all Events require TERM), and with Qualifiers as
necessary. Findings are often sufficiently described only the TESTCD
(the Topic Variable value), while Interventions typically require
several Qualifiers (e.g., Dose, Doseform, Route). Unscheduled
Interventions and Events may need only a Domain (e.g., AE or ConMed) and
a Qualifier describing the Evaluation Interval (see 1.4.3 for more
detail). For Uncheduled Interventions and Events, a qualifier indicating
a category (e.g., BODYSYS or CAT) may be needed (e.g, Bleeding Events,
AIDS-defining Events, Migraine Medications, Arthritis Surgeries).

### Mechanisms for Describing Timings

There are three basic mechanisms for describing the timing of
activities.

-   The activity is to be performed **during** a visit or a window (a
    visit-like time interval that is not a \"clinical encounter\").

-   The activity is to be performed at **a certain time before or
    after** another activity.

As mentioned above, these instructions may also be modified by
specifying the **order** of activities within a group (in the Planned
Activities dataset) or regimen (in the Planned Regiments dataset). In
addition, the order of activities within a visit or window may be
specified in the Trial Activities dataset..

#### Trial Anchors and Offsets

When the timing of an activity is described by referencing another
activity, that reference activity is called a **Trial Anchor**. The germ
of the Trial Anchor concept is present in the Start Rules in the Trial
Elements and Trial Visits datasets. It is also present in the Reference
Timepoint timing variable in the SDTM Timing Variables. The time
relative to a Trial Anchor (e.g., \"5 minutes before\" or \"2 weeks
after\") is called an **Offset**.

A Trial Anchor has two characteristics: something that happens (a
\"happening\"), and the time at which it happens. Every trial has at
least two Trial Anchors, Trial Entry (the happening that marks the
beginning of the first element) and Trial Exit (the happening that marks
the end of the last element), and there is no upper limit to the number
of Trial Anchors. Any activity that serves as the reference point for
describing the start of another activity is a Trial Anchor. Trial
Anchors are defined in one of two datasts:

-   The Trial Anchors dataset defines individual Trial Anchors.

-   The Periodic Trial Anchors Group dataset defines series of Trial
    Anchors that are related by a common offset. The first Trial Anchor
    in the series. TA~1~, is defined relative to a \"base\" Trial
    Anchor, TA~o~, using an Initial Offset between TA~1~ and TA~o~. Each
    Trial Anchor in the series is offset from the previous Trial Anchor
    by the Periodic Offset; TA~n+1~ is scheduled to take place at
    Periodic Offset after TA~n~ The series ends when the End Condition
    is met, so the number of Trial Anchors in a Periodic Trial Anchors
    Group may be fixed, may have an upper limit, or may be indefinite.

There are several ways in which offsets may be used to schedule
activities.

-   A positive Offset means that the activity is scheduled after the
    Trial Anchor (e.g., 2 weeks after start of study drug).

-   A negative Offset means that the activity is scheduled before the
    anticipated time of the Trial Anchor happening (e.g., 5 minutes
    pre-dose).

-   A range of Offsets means that the activity should take place after
    an Offset equal to the lower limit of the range, but before the
    upper limit of the range.

-   An Offset Group may be defined, and then used as often as needed.
    Offset Groups are created for convenience, and are optional

-   A Periodic Offset Group may be defined. A Periodic Offset Group is
    structured much like a Periodic Trial Anchors Group, except that
    Activities scheduled using a Periodic Offset Group are all \"tied\"
    to the initial Trial Anchor. The 1^st^ activity in the series is
    scheduled at the Initial Offset after the base Trial Anchor, while
    the nth activity is scheduled at (Initial Offset + (n-1)\*Periodic
    Offset) after the base Trial Anchor.

#### Visits and windows

Visits are related to Anchors through their Start and End Rules. The
instruction to perform an activity at a visit, means perform the
activity after the start of the visit and before the end of the visit.
In fact, many protocols include only sketchy information about visit end
rules. In some circumstances, this lack of precise planning can give
rise to ambiguity, but for many outpatient trials this level of
description is adequate. Note that for many outpatient trials, a single
nominal Visit is used for screening and baseline data that may be
collected at several clinical encounters. Inpatient trials typically
require more careful definition of visit starts and ends.

This version of the TDM augments to concept of Visit with the following
mechanisms:

-   The **Trial Windows** dataset allows the definition of visit-like
    time intervals which are not \"clinical encounters\" in the usual
    sense. These may be used for sets of activities which take place
    outside the clinic.

-   The **Visit Groups** dataset allows grouping of a set of visits.
    This is useful when the visits all have the same planned activities.

### Conditions on Activities

Scheduled activities may not be performed for all subjects, or in all
circumstances.

-   Interventions may be given only to subjects in certain arms.

-   Activities may only be performed for subjects with certain
    characteristics (e.g., pregnancy tests are performed only for
    females of child bearing potential)

-   Activities may be performed only under certain circumstances (e.g.,
    creatinine clearance is obtained only if a creatinine value is above
    a certain threshold, or rescue medication is given only when certain
    criteria are met).

-   Data on unscheduled interventions is collected only if they occurred
    within a certain time period (e.g., only adverse events that occur
    during the study are recorded, or only migraine medications taken in
    the 30 days before the start of study are recorded).

#### Restrictions on Performing Activiites

Restriction of activities to certain arms is indicated by populating ARM
in the Trial Activities dataset. A record is required for each ARM.

Restriction of activities to certain subjects or to certain
circumstances is indicated by populating IFCOND in the Trial Activities
dataset. IFCOND is a text field, but it may be useful to use
\"pseudo-code\" to make the conditions clear. For instance, restriction
to females of childbearing condition might be indicated with, \"If
DM.SEX=F and SC.CHDPOT=Y\".

#### Time restrictions on data collection: Evaluation Intervals and Windows

Data on unscheduled activities (e.g., Adverse Events and Concomitant
Medications) is usually collected in one of the following ways.

-   Data is collected on the interventions or events that occurred
    during a time period defined by the time of data collection and a
    duration. Interventions or events that occurred between the time of
    collection and the time of collection minus the duration are to be
    recorded. This kind of evaluation interval was envisioned when the
    SDTM variable EVLINT, which contains an ISO8601 duration value, was
    created. This kind of data collection is described by including
    EVLINT and a duration in a QNAM/QVAL pair (QNAM=EVLINT,
    QVAL=duration).

-   Data is collected about interventions or events that occurred during
    a time period described by a start time and an end time, rather than
    a duration. An example is data collected about chemotherapy
    toxicities collected for each cycle. Since cycles may vary in
    length, a duration is insufficient to describe such data collection.
    An Evaluation Window is defined, and used in a QNAM/QVAL pair
    (QNAM=EVLWIN, QVAL=name of evaluation window).

-   Incremental data is collected on events or interventions that
    started, ended, or changed since the last data collection. In this
    situation, the date of data collection is of little or no interest,
    and may not be collected. Such \"running log\" data is still limited
    in time, for instance to the time of the subject\'s participation in
    the study. In such a case, there is a \"monitoring interval\"
    associated with the entire running log, and this monitoring interval
    is described with a beginning and end. Again, an Evaluation Window
    is defined, and and used in a QNAM/QVAL pair (QNAM=EVLWIN, QVAL=name
    of evaluation window).

-   Data is collected at the point of data collection. This is
    \"snapshot\" or point data collection, rather than collection over
    an interval of time, so there is no evaluation interval or
    evaluation window.

Evaluation intervals are included in this section on timings because it
is easy to confuse the evaluation interval \"timing\" with the timing
that occurs in the Trial Activities dataset. The evaluation interval for
an activity should be included in the qualifiers when the activity is
defined. The timing included in the Trial Activities dataset is the
timing of data collection. This confusion does not arise for Findings or
Planned Interventions, where the time of the finding or intervention is
the scheduled time and (usually) the data collection time. For
Unscheduled Interventions and Events, the scheduled time is the time of
data collection, while the start and end time of the intervention or
event are unscheduled. The evaluation interval determines whether data
is collected.

# The Trial State Machine

## The Trial State Machine

Trial Elements, Trial Arm Segments, and Trial Arms, along with Trial
Epochs (which are part of the Trial Arms dataset), describe the trial
\"state machine.\" Trial Epochs describe the trial state machine.
Usually, subjects transition from one Epoch to another sequentially, as
in this example:

For a blinded trial, this high level view of the trial corresponds to
the view of participants who are blind to treatment.

There may be alternative paths, as in the following example, where open
label treatment may be skipped under certain conditions.

In the view of the trial that includes arms (i.e., the \"unblended\"
view), the state machine is more complex. Here is the first trial again,
with the arm-specific sub-states nested within the trial-level Epoch
states, and the arms indicated with connecting arrows of different
colors:

Thus, Trial Elements are assembled into both Arms, which represent the
path of a subject through the trial, and Epochs, which are trial states
that cut across arms. Commonly, the \"cells\" defined by the
intersection of Arms and Epochs contain one element each as in this
representation of the last example:

  ----------- ----------- ----------- ----------- ----------- -----------
              **Trial     **First     **Second    **Third     **Trial
              Screen      Treatment   Treatment   Treatment   Follow-up
              Epoch**     Epoch**     Epoch**     Epoch**     Epoch**

  **Arm       Screen      Placebo     Drug 5 mg   Drug 10 mg  Follow-up
  P-5-10**                                                    

  **Arm       Screen      Drug 5 mg   Placebo     Drug 10 mg  Follow-up
  5-P-10**                                                    

  **Arm       Screen      Drug 5 mg   Drug 10 mg  Placebo     Follow-up
  5-10-P**                                                    
  ----------- ----------- ----------- ----------- ----------- -----------

However, sometimes cells can have more than one Element within an Epoch,
as in this example:

  -------------- -------------- ----------------- ----------------- --------------
                 **Screen       **Treatment                         **Follow-up
                 Epoch**        Epoch**                             Epoch**

  **Arm A**      Screen         Investigational   Investigational   Follow-up
                                Treatment, Phase  Treatment, Phase  
                                1                 2                 

  **Arm B**      Screen         Standard Care                       Follow-up
  -------------- -------------- ----------------- ----------------- --------------

The sequence of Elements within an Epoch for an Arm is the **Arm
Segment**.

Another situation in which the concept of Arm Segments may be useful is
a trial with repeating cycles of treatment or follow-up, as in this
example:

  ----------------- ----------------- ----------------- -----------------
                    **Screen Epoch**  **Treatment       **Follow-up
                                      Epoch**           Epoch**

  **Arm A**         Screen            Treatment A, Rest Follow-up, repeat
                                      1, repeat from    until Condition Y
                                      Treatment A until is met
                                      Condition X is    
                                      met.              

  **Arm B**         Screen            Treatment B, Rest Follow-up, repeat
                                      1, repeat from    until Condition Y
                                      Treatment B until is met
                                      Condition X is    
                                      met.              

  **Arm C**         Screen            Treatment C, Rest Follow-up, repeat
                                      2, repeat from    until Condition Y
                                      Treatment B until is met
                                      Condition X is    
                                      met.              
  ----------------- ----------------- ----------------- -----------------

## Trial Elements

This dataset is unchanged from the existing SDTM V1 dataset.

**One record per Trial Element**

  ------------------------------------------------------------------------------------------------------------------
  **Variable   **Variable     **Type**   **Controlled   **Origin**   **Role**     **CDISC Notes**         **Core**
  Name**       Label**                   Terms or                                                         
                                         Format**                                                         
  ------------ -------------- ---------- -------------- ------------ ------------ ----------------------- ----------
  STUDYID      Study          Char                      CRF          Identifier   Unique identifier for a Req
               Identifier                                                         study within the        
                                                                                  submission.             

  DOMAIN       Domain         Char       \*                                       Two-character           Req
               Abbreviation                                                       abbreviation for the    
                                                                                  domain, which must be   
                                                                                  TE.                     

  ETCD         Element Code   Char        \*                                      Short 8-character name  Req
                                                                                  for ELEMENT, used for   
                                                                                  programming.            

  ELEMENT      Description of Char       \*                                       The name of the Element Req
               Element                                                                                    

  TESTRL       Rule for Start Char                                                Expresses rule for      Req
               of Element                                                         beginning of Element.   

  TEENRL       Rule for End   Char                                                Expresses rule for      Per
               of Element                                                         ending the Element      

  TEDUR        Planned        Char                                                Planned Duration of     Per
               Duration of                                                        Element in ISO 8601     
               Element                                                            format. For use when    
                                                                                  the rule for ending the 
                                                                                  Element is to end after 
                                                                                  a fixed duration.       
  ------------------------------------------------------------------------------------------------------------------

Questions:

-   I now think that a Trial Anchor is tied to an Epoch, rather than an
    Element. I.e., that an anchor should be defined in terms that can be
    recognized while participants are blinded (e.g., \"The first dose of
    drug in the second treatment epoch,\" rather than \"The first 5 mg
    dose\"). This makes description of Element Start Rules slightly more
    complicated (see first assumption, below).

Assumptions/Conventions:

-   TESTRL should be defined by naming a Trial Anchor or a Trial Anchor
    and an Offset and, where needed, information about treatment. (e.g.,
    The first dose of a treatment epoch where dose is 5 mg).

-   One of TEENRL and TEDUR must be populated.

## Trial Arm Segments

**One record per Trial Element per Arm Segment**

+-------+----------+---+----+----+-----+---------------------+---+----+
| **Var | **       | * | ** | ** | **  | **CDISC Notes**     | * | ** |
| iable | Variable | * | Co | Or | Rol |                     | * | Re |
| N     | Label**  | T | nt | ig | e** |                     | C | fe |
| ame** |          | y | ro | in |     |                     | o | re |
|       |          | p | ll | ** |     |                     | r | nc |
|       |          | e | ed |    |     |                     | e | es |
|       |          | * | T  |    |     |                     | * | ** |
|       |          | * | er |    |     |                     | * |    |
|       |          |   | ms |    |     |                     |   |    |
|       |          |   | or |    |     |                     |   |    |
|       |          |   | Fo |    |     |                     |   |    |
|       |          |   | rm |    |     |                     |   |    |
|       |          |   | at |    |     |                     |   |    |
|       |          |   | ** |    |     |                     |   |    |
+=======+==========+===+====+====+=====+=====================+===+====+
| ST    | Study    | C |    | C  | I   | Unique identifier   | R | SD |
| UDYID | Id       | h |    | RF | den | for a study within  | e | TM |
|       | entifier | a |    |    | tif | the submission.     | q |    |
|       |          | r |    |    | ier |                     |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+
| D     | Domain   | C | \* |    |     | Two-character       | R | SD |
| OMAIN | Abbr     | h |    |    |     | abbreviation for    | e | TM |
|       | eviation | a |    |    |     | the domain, which   | q |    |
|       |          | r |    |    |     | must be AS?         |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+
| ARM   | Arm      | C | \* |    |     | Short 8-character   | R |    |
| SEGCD | Segment  | h |    |    |     | version of ARMSEG,  | e |    |
|       | Code     | a |    |    |     | used for            | q |    |
|       |          | r |    |    |     | programming.        |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+
| A     | Planned  | C |    |    |     | The name given to   | R |    |
| RMSEG | Arm Code | h |    |    |     | the Arm Segment     | e |    |
|       |          | a |    |    |     |                     | q |    |
|       |          | r |    |    |     |                     |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+
| ETORD | Order of | N |    |    |     | Number that gibes   | R |    |
|       | Element  | u |    |    |     | the order for the   | e |    |
|       | within   | m |    |    |     | Element within the  | q |    |
|       | Arm      |   |    |    |     | Arm Segment         |   |    |
|       | Segment  |   |    |    |     |                     |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+
| ETCD  | Element  | C |    |    |     | Short 8-character   | R | SD |
|       | Code     | h | \* |    |     | name for ELEMENT,   | e | TM |
|       |          | a |    |    |     | used for            | q |    |
|       |          | r |    |    |     | programming.        |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+
| EL    | Des      | C | \* |    |     | The name of the     | R |    |
| EMENT | cription | h |    |    |     | Element             | e |    |
|       | of       | a |    |    |     |                     | q |    |
|       | Element  | r |    |    |     |                     |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+
| RPTRL | Rule for | C |    |    |     | If null, the        | P |    |
|       | R        | h |    |    |     | elements within the | e |    |
|       | epeating | a |    |    |     | arm segment do not  | r |    |
|       | Element  | r |    |    |     | repeat.             |   |    |
|       |          |   |    |    |     |                     |   |    |
|       |          |   |    |    |     | If elements do      |   |    |
|       |          |   |    |    |     | repeat, this is the |   |    |
|       |          |   |    |    |     | ETORD of the first  |   |    |
|       |          |   |    |    |     | arm segment that is |   |    |
|       |          |   |    |    |     | repeated.           |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+
| RP    | Rule for | C |    |    |     | Expresses the rule  | P |    |
| TENRL | Ending   | h |    |    |     | for ending          | e |    |
|       | Re       | a |    |    |     | repetition of the   | r |    |
|       | petition | r |    |    |     | Arm Segment. May be |   |    |
|       | of Arm   |   |    |    |     | a fixed number of   |   |    |
|       | Segment. |   |    |    |     | repetitions, or a   |   |    |
|       |          |   |    |    |     | condition for       |   |    |
|       |          |   |    |    |     | ending repetition.  |   |    |
+-------+----------+---+----+----+-----+---------------------+---+----+

Issues/Questions:

-   What should the domain code for this dataset be? I have suggested
    AS.

-   Is TATRANS needed in this dataset? (I think it may be. Example:
    under certain conditions, jump out of the Arm Segment, to the next
    Epoch, or skip part of the arm segment.)

-   Is BRANCH needed in this dataset? (I think it may be. Example:
    branch to standard care or surgery. After surgery, branch to one of
    two post-op strategies. Second branch does not take place at an
    Epoch transition.)

-   Allowing repetitions of Arm Segments means that there is not a
    unique \"sequence number\" (value of TAETORD) for each element for
    use in the Subject Elements dataset. Instead, for Epochs that
    repeat, you must specify the Epoch (by means of EPORD, see below),
    the Element (by means of ETORD) and a repeat number (CYCLE?), e.g.,
    if a trial has three Epochs (Screen with EPORD=1, Treatment with
    EPORD=2, and Follow-up with EPORD=3), and two Elements within a
    repeating Arm Segment, then a subject might have the following
    elements:

  -------------------------- -------------------- -----------------------
  EPORD                      CYCLE                ETORD

  1                                               1

  2                          1                    1

  2                          1                    2

  2                          2                    1

  2                          2                    2

  2                          3                    1

  2                          3                    2

  3                                               1
  -------------------------- -------------------- -----------------------

I think this is an improvement, but it is a change to the Subject
Elements Dataset.

Assumptions/Conventions:

-   Branches can take place only at the transition from one Epoch to the
    next. (But see question under Trial Arm Segments.)

-   If an Arm Segment consists of exactly one non-repeating element,
    then it is unnecessary to define it in the Arm Segments dataset. The
    Arm Segment can be referenced in the Trial Arms table by using the
    name of the Element in ARMSEG and the code for the Element in
    ARMSEGCD

-   If there is a repeating Arm Segment, even if it consists of only one
    element, then there must be a Trial Arm Segments dataset.

-   The names and codes of Arm Segments must be different from the names
    and codes for Elements.

-   If all Arm Segments in the Trial consist of single, non-repeating
    elements, then an explicit Trial Arm Segments table is unnecessary.

## Trial Arms

The existing Trial Arms and Trial Elements datasets, with the addition
of the new Trial Arm Segments dataset, allow the definition of Epochs.
Epochs and Elements provide the basic timing skeleton of the trial.

Changes from the original Trial Arms dataset to this version:

-   Arms are assembled from Arm Segments, rather than Arms

-   EPORD replaces TAETORD

-   EPOCH is included

**One record per Arm Segment per Arm**

  ---------------------------------------------------------------------------------------------------------------------------------
  **Variable   **Variable     **Type**   **Controlled   **Origin**   **Role**     **CDISC Notes**       **Core**   **References**
  Name**       Label**                   Terms or                                                                  
                                         Format**                                                                  
  ------------ -------------- ---------- -------------- ------------ ------------ --------------------- ---------- ----------------
  STUDYID      Study          Char                      CRF          Identifier   Unique identifier for Req        SDTM
               Identifier                                                         a study within the               
                                                                                  submission.                      

  DOMAIN       Domain         Char       \*                                       Two-character         Req        SDTM
               Abbreviation                                                       abbreviation for the             
                                                                                  domain, which must be            
                                                                                  TA.                              

  ARMCD        Arm Code       Char        \*                                      Short 8-character     Req        SDTM
                                                                                  name for ARM, used               
                                                                                  for programming.                 

  ARM          Description of Char       \*                                       The name of the       Req        
               Arm Segment                                                        Element                          

  EPORD        Order of Epoch Num                                                 Number that gives the Req        
               within Arm                                                         order for the Epoch              
                                                                                  within the trial.                
                                                                                  This is also, by                 
                                                                                  definition, the order            
                                                                                  for the Arm Segment              
                                                                                  within the Arm.                  

  EPOCH        Trial Epoch    Char                                                Name of the Trial     Req        
                                                                                  epoch with which this            
                                                                                  Arm Segment of the               
                                                                                  Arm is associated.               

  ARMSEGCD     Arm Segment    Char       \*                                       Short 8-character     Req        
               Code                                                               version of ARMSEG,               
                                                                                  used for programming.            

  ARMSEG       Planned Arm    Char                                                Name given to an Arm  Req        
               Code                                                               Segment                          

  TABRANCH     Branch         Char                                                Condition subjects               
                                                                                  meet, at a fork in               
                                                                                  the Trial Design, at             
                                                                                  the end of this Arm              
                                                                                  Segment (Epoch), to              
                                                                                  be included in this              
                                                                                  Arm. Example:                    
                                                                                  Randomization to Drug            
                                                                                  A.                               

  TATRANS      Transition     Char                                                If the Trial Design              
               Rule                                                               allows subjects to               
                                                                                  transition to an Arm             
                                                                                  Segment (Epoch) other            
                                                                                  than the next Arm                
                                                                                  Segment (Epoch) in               
                                                                                  sequence, then the               
                                                                                  conditions for                   
                                                                                  transitioning to                 
                                                                                  those Arm Segments               
                                                                                  (Epochs) are                     
                                                                                  specified in this                
                                                                                  rule. Example:                   
                                                                                  Responders go to                 
                                                                                  washout.                         
  ---------------------------------------------------------------------------------------------------------------------------------

Issues/Questions:

-   Change from TAETORD to EPORD okay?

Assumptions/Conventions:

-   The name and code for an Element may occur in the Trial Arms table.
    This means that the Arm Segment consists of just the one named
    element.

-   The order of Epochs must be the same for all Arms in the trial.

-   There is one Arm Segment in each Arm for each Epoch.

-   The transitions between epochs and elements occur at Trial Anchors
    or at an Offset after a Trial Anchors

# Activity Definition Datasets

## Defining Activities

Activities fall into two general classes, each of which is defined
slightly differently.

Scheduled activities are activities whose performance is scheduled.
These include Findings (tests and examinations), Interventions that are
planned by the trial\'s Protocol, and \"snapshot\" (point in time)
evaluations of events and of interventions that are not planned by the
trial\'s protocol.

Unscheduled activities are activities which record data about events and
interventions that are not planned by the trial\'s protocol. They record
more data over a time interval (an evaluation interval), rather than at
a point in time (a \"snaphot\").

The information needed to a define an activity varies according whether
it is Scheduled or Unscheduled, and its class (Finding, Intervention, or
Event).

Scheduled Activities

-   Findings require a Domain (e.g., Lab, ECG), and a TESTCD (the topic
    variable for a Findings domain). For some findings, the protocol may
    also specify qualifiers such as Position or Location.

-   Scheduled Interventions require a Domain (e.g., Exposure), and a TRT
    (the topic variable for an Interventions domain). For most scheduled
    interventions, the protocol will also specify several qualifiers,
    such as DOSE, DOSFRM, and ROUTE.

-   Activities for recording Snapshot evaluations of unscheduled
    interventions require a Domain (e.g., Substance Use), and a TRT or
    CLAS or CAT. The protocol may also specify qualifiers.

-   Activities for recording Snapshot evaluations of events require a
    Domain (e.g., Adverse Events or Symptoms), and a TERM (the topic
    variable for an Events domain). \[How to deal with the case where
    the CRF allows writing in a subject-specific TERM, which is then
    tracked in snapshots?\]

Unscheduled Activities

-   Activities to record non-snapshot data on Unscheduled Interventions
    require a Domain (e.g., Con Meds), and an Evaluation Interval. The
    protocol may also specify a CLAS or CAT.

-   Activities for recording non-snapshot data on Events require a
    Domain (e.g., AE), and an Evaluation Interval. The protocol may also
    specify a BODYSYS or CAT.

## Grouping Activities

There are two mechanisms for grouping activities. The simpler of these
two mechanisms operates in the Planned Activities dataset and allows
grouping, and ordered grouping, of activities. More complex groupings,
that involve offsets between related activities, are specified by
creating a Planned Regimen.

## Planned Activities

This table serves to define activities that are part of the plan of the
trial.

ANAME holds the name of a planned activity. ANAME is defined by a group
of records, all with the same value of TOPIC, but with different values
of QNAM and QVAL. For example, if a planned intervention consists of 40
mg of Drug X, in the form of a capsule to be taken orally, there would
be four records that constitute the description of that intervention,
one each for DOSE, DOSEU, DOSFRM, and ROUTE. ANAME serves both to
declare the name of the planned intervention and to group the records
together.

AGRP holds the name of an Activities Group. If the activities in
anActivities Group are to be performed in a particular order (e.g., the
questions in a validated questionnaire), this may be specified in
GRPORD.

**One record per planned activity qualifier**

+-------+-----------+---+----+-----+------+----------------------+---+
| **Var | *         | * | ** | *   | **Ro | **CDISC Notes**      | * |
| iable | *Variable | * | Co | *Or | le** |                      | * |
| N     | Label**   | T | nt | igi |      |                      | C |
| ame** |           | y | ro | n** |      |                      | o |
|       |           | p | ll |     |      |                      | r |
|       |           | e | ed |     |      |                      | e |
|       |           | * | T  |     |      |                      | * |
|       |           | * | er |     |      |                      | * |
|       |           |   | ms |     |      |                      |   |
|       |           |   | or |     |      |                      |   |
|       |           |   | Fo |     |      |                      |   |
|       |           |   | rm |     |      |                      |   |
|       |           |   | at |     |      |                      |   |
|       |           |   | ** |     |      |                      |   |
+=======+===========+===+====+=====+======+======================+===+
| ST    | Study     | C |    | CRF | Id   | Unique identifier    | R |
| UDYID | I         | h |    |     | enti | for a study within   | e |
|       | dentifier | a |    |     | fier | the submission.      | q |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| D     | Domain    | C | \* |     |      | Two-character        | R |
| OMAIN | Abb       | h |    |     |      | abbreviation for the | e |
|       | reviation | a |    |     |      | domain, which must   | q |
|       |           | r |    |     |      | be PA?               |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| ANAME | Name of   | C |    |     |      | ANAME should be the  | R |
|       | Planned   | h |    |     |      | name of an activity. | e |
|       | Activity  | a |    |     |      |                      | q |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| AD    | Domain of | C | \* |     |      |                      | R |
| OMAIN | Planned   | h |    |     |      |                      | e |
|       | Activity  | a |    |     |      |                      | q |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| TOPIC | Value of  | C |    | CRF | T    | For Findings, a      | D |
|       | Topic     | h |    | or  | opic | TESTCD, for          | e |
|       | Variable  | a |    | R   |      | Interventions, a     | p |
|       | for the   | r |    | and |      | TRT, for Events, a   | e |
|       | Domain    |   |    | omi |      | TERM.                | n |
|       |           |   |    | zat |      |                      | d |
|       |           |   |    | ion |      |                      | s |
|       |           |   |    | F   |      |                      |   |
|       |           |   |    | ile |      |                      |   |
|       |           |   |    | or  |      |                      |   |
|       |           |   |    | D   |      |                      |   |
|       |           |   |    | eri |      |                      |   |
|       |           |   |    | ved |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| QNAM  | Qualifier | C |    |     |      | Values to taken from | P |
|       | of        | h |    |     |      | Qualifiers in the    | e |
|       | Planned   | a |    |     |      | general class (e.g., | r |
|       | Treatment | r |    |     |      | LOC, DOSE, BODYSYS)  |   |
|       |           |   |    |     |      | or from values used  |   |
|       |           |   |    |     |      | for QNAM in SUPPQUAL |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| QVAL  | Value of  | C |    |     |      | Value of the         | P |
|       | QUALVAL   | h |    |     |      | variable QUAL        | e |
|       |           | a |    |     |      | planned for this TRT | r |
|       |           | r |    |     |      |                      |   |
|       |           |   |    |     |      | For example, QNAM=   |   |
|       |           |   |    |     |      | DOSE, QVAL=15        |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| AGRP  | Name of   | C |    |     |      |                      | P |
|       | Activity  | h |    |     |      |                      | e |
|       | Group     | a |    |     |      |                      | r |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| G     | Order of  | N |    |     |      | Indicates that this  | P |
| RPORD | Activity  | u |    |     |      | activity should be   | e |
|       | with      | m |    |     |      | performed after      | r |
|       | Activity  |   |    |     |      | activities in the    |   |
|       | Group     |   |    |     |      | same AGRP with a     |   |
|       |           |   |    |     |      | lower value of GPORD |   |
|       |           |   |    |     |      | and before           |   |
|       |           |   |    |     |      | activities in the    |   |
|       |           |   |    |     |      | same AGRP with a     |   |
|       |           |   |    |     |      | higher value of      |   |
|       |           |   |    |     |      | GPORD.               |   |
+-------+-----------+---+----+-----+------+----------------------+---+

*\* indicates variable may be subject to controlled terminology.*

Development Notes:

Questions:

-   What should the domain code for this dataset be? I have suggested
    PA.

-   Is it okay to use QNAM and QVAL, which are variable names in
    SUPPQUAL, in this context? The values QNAM takes on could be either
    qualifiers from the general class or ones used in SUPPQUAL.

-   TOPIC is required for some kinds of activities, not for others. So
    is it \"Expected\" over all?

-   Can an Activity be part of more than one Activity Group?

-   For a Finding, is TESTCD enough? When I had Planned Findings
    separate, I also included TEST.

-   In an earlier draft, I included TEXT, the complete text of the
    question. I was thinking of questionnaires. Could this be treated as
    a Qualifier, if needed? It\'s something we have in TI, and is
    something you\'d really rather have only in metadata (which is sort
    of what Planned Activities is), rather than subject data. If TEXT is
    included, then a mechanism for dealing with long text values will be
    needed.

-   There are some things that I think of as non-data activities, like
    obtaining informed consent, but if these are to serve as Trial
    Anchors used as Element transition points, then at least a date must
    be collected. I think these are events, probably Disposition Events.
    Does that make sense?

-   Is GRPID needed? I think that ANAME fulfills this purpose, though it
    may not work if only some of the records with an ANAME are part of
    the definition of that ANAME. This might happen if an ANAME can be
    used in more than one AGRP, or if separate records are used to
    define an ANAME and to put it into an AGRP.

Assumptions/Conventions:

-   This dataset is required.

-   \"Exceptions\" such as dose adjustments in response to adverse
    events are not modeled.

-   Planned Activities is about collected data. It does not include
    Derived Data.

-   Planned Activities does not specify what data about the activity
    will be collected.

-   An activity may be a \"singleton,\" not part of any Activity Group.

-   If multiple records are needed to define an Activity, then all of
    them must have the same value of AGRP and GPORD. \[Is this a
    problem? If so, then perhaps all grouping of activities should be
    moved into Planned Regimens. Or perhaps you can define an ANAME in
    one set of records, then use the ANAMES in other records to create
    an AGRP?\]

-   QUAL should hold aspects of the test, not aspects of the result
    (e.g., units, normal range, MODIFY, SEV, DTHREL) or timing
    variables.

-   The groupings of findings described by CAT and SCAT are may or may
    not match the groupings in the Planned Findings dataset.

-   Only supply QNAM & QVAL where needed -- don\'t specify anything
    that\'s not needed.

## Planned Regimens

This dataset groups activities that constitute a \"regimen\". A Planned
Regimen allows for scheduling of activities within a Regimen by means of
Offsets, as well as order (RGORD).

+-------+-----------+---+----+-----+------+----------------------+---+
| **Var | *         | * | ** | *   | **Ro | **CDISC Notes**      | * |
| iable | *Variable | * | Co | *Or | le** |                      | * |
| N     | Label**   | T | nt | igi |      |                      | C |
| ame** |           | y | ro | n** |      |                      | o |
|       |           | p | ll |     |      |                      | r |
|       |           | e | ed |     |      |                      | e |
|       |           | * | T  |     |      |                      | * |
|       |           | * | er |     |      |                      | * |
|       |           |   | ms |     |      |                      |   |
|       |           |   | or |     |      |                      |   |
|       |           |   | Fo |     |      |                      |   |
|       |           |   | rm |     |      |                      |   |
|       |           |   | at |     |      |                      |   |
|       |           |   | ** |     |      |                      |   |
+=======+===========+===+====+=====+======+======================+===+
| ST    | Study     | C |    | CRF | Id   | Unique identifier    | R |
| UDYID | I         | h |    |     | enti | for a study within   | e |
|       | dentifier | a |    |     | fier | the submission.      | q |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| D     | Domain    | C | \* |     |      | Two-character        | R |
| OMAIN | Abb       | h |    |     |      | abbreviation for the | e |
|       | reviation | a |    |     |      | domain, which must   | q |
|       |           | r |    |     |      | be PR?               |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| AREG  | Name of   | C |    |     |      | The name of this     |   |
|       | Activity  | h |    |     |      | group of             |   |
|       | Regimen   | a |    |     |      | interventions        |   |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| ANAME | Name of   | C |    |     |      | The name of this     |   |
|       | Planned   | h |    |     |      | intervention.        |   |
|       | Activity  | a |    |     |      | Examples: Placebo,   |   |
|       |           | r |    |     |      | Low Dose, Comparator |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| R     | Sequence  | C |    |     |      | Order of this        |   |
| EGORD | number    | h |    |     |      | intervention within  |   |
|       |           | a |    |     |      | the Intervention     |   |
|       |           | r |    |     |      | Group.               |   |
|       |           |   |    |     |      |                      |   |
|       |           |   |    |     |      | Used when offsets    |   |
|       |           |   |    |     |      | aren\'t specified.   |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| O     | Offset    | I |    |     |      | An offset expressed  |   |
| FFSET |           | S |    |     |      | as a duration using  |   |
|       |           | O |    |     |      | ISO8601 format       |   |
|       |           | 8 |    |     |      |                      |   |
|       |           | 6 |    |     |      |                      |   |
|       |           | 0 |    |     |      |                      |   |
|       |           | 1 |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| OF    | Second    | I |    |     |      |                      |   |
| FSET1 | Offset,   | S |    |     |      |                      |   |
|       | for use   | O |    |     |      |                      |   |
|       | in        | 8 |    |     |      |                      |   |
|       | defining  | 6 |    |     |      |                      |   |
|       | ranges of | 0 |    |     |      |                      |   |
|       | offsets   | 1 |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+

Issues/Questions:

-   What should the domain code for this dataset be? I have suggested
    PR.

-   An activity with a zero offset coincides with the \"anchor\" for the
    activity. Should this regiment anchor be included in the Planned
    Regimens dataset? If the Planned Regimen is in the Trial Activities
    dataset with a Visit or Window, then it has to be in the Planned
    Regimens dataset. If it\'s in the Planned Regimens dataset and also
    the Anchor for the regimen in the Trial Activities dataset, is that
    okay?

-   Order & Offset may be alternative ways to provide information about
    the \"togetherness,\" depending on what\'s needed.

-   Does this dataset need any \"if\" mechanisms, like ARM or IFCOND?

Assumptions/Conventions:

-   This dataset is optional.

The following table shows an example of a regimen for taking three blood
pressures. Assume that BPSIT has been defined, in the Planned Activities
dataset, as the group of two activities, SITSYS and SITDIA (systolic and
diastolic blood pressure with position sitting).

  ----------- ----------- ------------ ------------ ------------- --------------
  **AREG**    **ANAME**   **REGORD**   **OFFSET**   **OFFSET2**   **COMMENTS**

  BP          BPSIT       1            0                          1^st^
                                                                  repetition

  BP          BPSIT       2            P10M                       2^nd^
                                                                  repetition, 10
                                                                  minutes after
                                                                  first

  BP          BPSIT       3            P20M                       3rd
                                                                  repetition, 20
                                                                  minutes after
                                                                  first
  ----------- ----------- ------------ ------------ ------------- --------------

The next table shows an example of a regimen for administering a
chemotherapy drug with associated steroid treatment.

  ----------- ----------- ------------ ------------ ------------- --------------
  **AREG**    **ANAME**   **REGORD**   **OFFSET**   **OFFSET2**   **COMMENTS**

  COMBA       STEROID                  -P14H        -P10H         

  COMBA       STEROID                  -P2H         0             

  COMBA       DRUG A                   0                          

  COMBA       STEROID                  P10H         P14H          
  ----------- ----------- ------------ ------------ ------------- --------------

## Evaluation Intervals and Windows

Evaluation intervals are \"durations.\" There is already a timing
variable in the SDTM, EVLINT, which can be used as a Qualifier in any
domain. Evaluation windows also serve as qualifiers, but as they are
more complex than evaluation intervals, they must be defined for a
study. They are defined in the Evaluation Windows dataset.

Assumptions/Conventions:

-   If an Event activity includes an EVLINT Qualifier (i.e.,
    QNAM=EVLINT, QVAL=duration value), then data collection is
    restricted to the time period that starts {value} before the time of
    collection, and ends at the time of collection.

-   If an Event activity includes an EVLWIN Qualifier (i.e.,
    QNAM=EVLWIN, QVAL=name of evaluation window), then data collection
    is restricted to the named evaluation window.

-   If an Event activity includes neither an EVLINT Qualifier or an
    EVLWIN Qualifier, then data collection is a \"snapshot,\" i.e., it
    is restricted to the status of the event at the time of data
    collection, where \"status\" may include presence or absence,
    severity, etc.

**One record per Evaluation Window**

  ---------------------------------------------------------------------------------------------------------------------------------
  **Variable   **Variable     **Type**   **Controlled   **Origin**   **Role**     **CDISC Notes**       **Core**   **References**
  Name**       Label**                   Terms or                                                                  
                                         Format**                                                                  
  ------------ -------------- ---------- -------------- ------------ ------------ --------------------- ---------- ----------------
  STUDYID      Study          Char                      CRF          Identifier   Unique identifier for Req        SDTM
               Identifier                                                         a study within the               
                                                                                  submission.                      

  DOMAIN       Domain         Char       \*                                       Two-character         Req        SDTM
               Abbreviation                                                       abbreviation for the             
                                                                                  domain, which must be            
                                                                                  EW.                              

  EVLWIN       Evaluation     Char        \*                                                            Req        SDTM
               Window Name                                                                                         

  EWSTRL       Evaluation     Char                                                                      Req        
               Window Start                                                                                        
               Rule                                                                                                

  EWENRL       Evaluation     Char                                                                      Req        
               Window End                                                                                          
               Rule                                                                                                
  ---------------------------------------------------------------------------------------------------------------------------------

Issues/Questions:

-   Would \"monitoring window\" be a better term than \"evaluation
    window\"?

-   What should the domain code for this dataset be? I have suggested
    EW. (Or MW if this changes to Monitoring Window.)

-   Is this dataset required? I think it will almost always be needed,
    as AEs are almost always collected, and (I think) that the
    Evaluation Window for AEs should be specified.

Assumptions/Conventions:

-   The start and end rules should be expressed in terms of Anchors.

# Trial Activities

## Vocabulary for Trial Timings

This section describes the rationale for the timing variables in the
Trial Activities dataset.

Timing of activities can be described in one of several ways:

1.  Perform {activity} {offset} after {anchor point}.

2.  Perform {activity} {offset} before anticipated occurrence of {anchor
    point}.

3.  Perform {activity} after {offset 1} relative to {anchor point} and
    before {offset 2} relative to {anchor point}.

4.  Perform {activity} at each of a {set of offsets} relative to {anchor
    point}.

5.  Perform {activity} at each of a {periodic set of offsets} relative
    to {anchor point}.

6.  Perform {activity} at each of a {periodic set of anchor points}
    until {condition} is met.

7.  Perform {activity} during {visit}, after activities with a lower
    {order} and before activities with a higher {order}.

8.  Perform {activity} during each of a {set of visits}, after
    activities with a lower {order} and before activities with a higher
    {order}.

9.  Perform {activity} during {window}, after activities with a lower
    {order} and before activities with a higher {order}.

Where

> {activity} is an activity (ANAME), an activity group (AGRP) or regimen
> of activities (AREG) defined in the Planned Activities dataset or the
> Planned Regimens dataset.
>
> {offset} is a time interval (e.g., 2 days or 5 weeks, not a date or
> clock time) expressed in ISO3601. It may be zero.
>
> {anchor point} is a \"happening\" defined in the Trial Anchors dataset
> and the time at which it happens. It must be something that
> participants in the trial can recognize and for which they can record
> the time of occurrence. Note that the \"happening\" may be scheduled
> or unscheduled and may correspond to an SDTM Event, Intervention, or
> Finding.
>
> {set of offsets} is an offset group described in the Offset Groups
> dataset.
>
> {periodic set of offsets} is a periodic offset group described in the
> Offset Groups table. It consists of offsets y, y+1x, y+2x, y+3x, etc.,
> where y is the initial offset and x is the period. The value of y may
> be zero. The set may have a fixed number of offsets, or may end when a
> condition is met.
>
> {periodic set of anchor points} is a periodic offset group described
> in the Anchor Groups table. In a periodic set of anchors, there is an
> initial {anchor point}, then the {activity} is performed at {initial
> offset} after the initial {anchor point}. This first occurrence of the
> {activity} becomes the {anchor point} for the next {activity}, which
> occurs at {periodic offset} after the first. The nth activity is to
> occur at {periodic offset} after the n-1^th^ and beomes the {anchor
> point} for the n+1^th^ activity in the series. The set may have a
> fixed number of anchors, or may end when a condition is met. A series
> of activities is \"telescoping\" in the sense that if one activity is
> performed earlier or later than scheduled, then the schedule for all
> the rest of the activities moves up or back accordingly.
>
> {visit} is a visit defined in the Trial Visits table.
>
> {order} is a positive integer assigned to an activity to be performed
> during a visit. {order} values may be assigned to some or all of the
> activities associated with a visit.
>
> {set of visits} is a visit group defined in the Visit Groups table.
>
> {window} is a trial window defined in the Trial Windows table. A trial
> window has a start, defined as {offset} before or after {anchor point}
> and an end, defined as {offset} before or after {anchor point}.

The following table organizes the pieces of these possible statements
into columns. The columns are precursors to the variables in the Trial
Activities table.

  --- --------- ------------ --------- ----------- ----- ----------- ------------- ----------- ------------------
      1         2            3         4           5     6           7             8           9

  1   Perform   {activity}             {offset}                      after         {anchor}    

  2   Perform   {activity}             {offset}                      Before        {anchor}    
                                                                     anticipated               
                                                                     occurrence of             

  3   Perform   {activity}   between   {offset 1}  and   {offset2}   Relative to   {anchor}    

  4   Perform   {activity}   at each   {set of                       relative to   {anchor}    
                             of a      offsets}                                                

  5   Perform   {activity}   at each   {periodic                     relative to   {anchor}    
                             of a      set of                                                  
                                       offsets}                                                

  6   Perform   {activity}   at each                                               {periodic   
                             of a                                                  set of      
                                                                                   anchors}    

  7   Perform   {activity}                                           during        {visit}     After activities
                                                                                               with a higher, and
                                                                                               before activities
                                                                                               with a lower
                                                                                               {order}

  8   Perform   {activity}                                           during each   {set of     After activities
                                                                     of a          visits}     with a higher, and
                                                                                               before activities
                                                                                               with a lower
                                                                                               {order}

  9   Perform   {activity}                                           during        {window}    After activities
                                                                                               with a higher, and
                                                                                               before activities
                                                                                               with a lower
                                                                                               {order}
  --- --------- ------------ --------- ----------- ----- ----------- ------------- ----------- ------------------

The contents of columns of this table:

1.  \"perform\"

2.  {activity}

3.  \"between\" (used with a pair {offset1}, {offset2}) or \"at each
    of\" (used with an {offset group} or a {periodic set of offsets})

4.  {offset} or {offset 1} or {set of offsets} or {periodic set of
    offsets}

5.  \"and\" (used with a pair: {offset1}, {offset2})

6.  {offset 2}

7.  \"after\" or \"before anticipated occurrence of\" or \"relative to\"
    or \"each of a (which go with anchors) or \"during\" or \"during
    each of a\" (which go with visits and windows)

8.  {anchor} or {periodic set of anchors} or {visit} or {set of visits}
    or {window}

9.  \"after activities with a higher, and before activities with a
    lower\" {order}

Column 1: Always the same, can be inferred.

Columns 2, 4, 6, 8, and 9 contain the names of entities defined in other
tables, and become variables in the Trial Activities table. The words,
\"\"after activities with a higher, and before activities with a lower\"
need not be represented explicitly.

Column 3: The \"between\" can be inferred from the presence of two
offsets (in columns 4 and 6). The \"at each of\" can be inferred from
the contents of column 4.

Column 5: The \"and\" can be inferred from the presence of two offsets
(in columns 4 and 6).

Column 7: \"After\" or \"before\" can be conveyed by giving signs (+ or
-) to the offsets in columns 4 and 6.

Columns 2, 4, 6, 8, and 9 become the \"when\" variables of the Trial
Activity table:

Column 2 becomes ANAME, or Activity Name.

Column 4 becomes two variables:

> A variable OFFSET for timings with a single offset or a range of
> offsets
>
> A variable OFFGP for a group of offsets.

Column 6 becomes OFFSET2

Column 8 becomes two variables:

> A variable for intervals (Visits or Windows) or groups of visits
> called VISWIN
>
> A variable for anchors or groups of anchors called ANCHOR.

Column 9 becomes ORDER.

## Trial Activities Dataset

**TRIAL ACTIVITIES**

**One record per activity per timing.**

+-------+-----------+---+----+-----+------+----------------------+---+
| **Var | *         | * | ** | *   | **Ro | **CDISC Notes**      | * |
| iable | *Variable | * | Co | *Or | le** |                      | * |
| N     | Label**   | T | nt | igi |      |                      | C |
| ame** |           | y | ro | n** |      |                      | o |
|       |           | p | ll |     |      |                      | r |
|       |           | e | ed |     |      |                      | e |
|       |           | * | T  |     |      |                      | * |
|       |           | * | er |     |      |                      | * |
|       |           |   | ms |     |      |                      |   |
|       |           |   | or |     |      |                      |   |
|       |           |   | Fo |     |      |                      |   |
|       |           |   | rm |     |      |                      |   |
|       |           |   | at |     |      |                      |   |
|       |           |   | ** |     |      |                      |   |
+=======+===========+===+====+=====+======+======================+===+
| ST    | Study     | C |    | CRF | Id   | Unique identifier    | R |
| UDYID | I         | h |    |     | enti | for a study within   | e |
|       | dentifier | a |    |     | fier | the submission.      | q |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| D     | Domain    | C | \* |     |      | Two-character        | R |
| OMAIN | Abb       | h |    |     |      | abbreviation for the | e |
|       | reviation | a |    |     |      | domain, which must   | q |
|       |           | r |    |     |      | be SA?               |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| ANAME | Name of   | C |    |     |      | Name given to a      | R |
|       | Trial     | h |    |     |      | trial activity.      | e |
|       | Activity  | a |    |     |      | Could be a finding   | q |
|       |           | r |    |     |      | group, a medication  |   |
|       |           |   |    |     |      | or medication group, |   |
|       |           |   |    |     |      | an type of unplanned |   |
|       |           |   |    |     |      | event or             |   |
|       |           |   |    |     |      | intervention, or an  |   |
|       |           |   |    |     |      | Other Activity like  |   |
|       |           |   |    |     |      | \"Randomization\" or |   |
|       |           |   |    |     |      | \"Trial Exit\"       |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| O     | Time      | C | I  |     | Ti   | Offset (in ISO 8601) | P |
| FFSET | relative  | h | SO |     | ming | relative to the part | e |
|       | to ANCHOR | a | 86 |     |      | of the ANCHOR. A     | r |
|       |           | r | 01 |     |      | time point, not a    | m |
|       |           |   |    |     |      | time interval. Not a |   |
|       |           |   |    |     |      | clock time or a date |   |
|       |           |   |    |     |      | time variable.       |   |
|       |           |   |    |     |      |                      |   |
|       |           |   |    |     |      | Used for points in   |   |
|       |           |   |    |     |      | time, left blank for |   |
|       |           |   |    |     |      | interval timings.    |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| OF    | Second    | C | I  |     | Ti   | Offset (in ISO 8601) | P |
| FSET2 | time      | h | SO |     | ming | relative to the part | e |
|       | relative  | a | 86 |     |      | of the ANCHOR. A     | r |
|       | to ANCHOR | r | 01 |     |      | time point, not a    | m |
|       |           |   |    |     |      | time interval. Not a |   |
|       |           |   |    |     |      | clock time or a date |   |
|       |           |   |    |     |      | time variable.       |   |
|       |           |   |    |     |      |                      |   |
|       |           |   |    |     |      | Used, in conjunction |   |
|       |           |   |    |     |      | with OFFSET, when an |   |
|       |           |   |    |     |      | activity is          |   |
|       |           |   |    |     |      | scheduled to take    |   |
|       |           |   |    |     |      | place within a range |   |
|       |           |   |    |     |      | of times between     |   |
|       |           |   |    |     |      | (ANCHOR, OFFSET) and |   |
|       |           |   |    |     |      | (ANCHOR, OFFSET2).   |   |
|       |           |   |    |     |      |                      |   |
|       |           |   |    |     |      | OFFSET2 should be    |   |
|       |           |   |    |     |      | greater than         |   |
|       |           |   |    |     |      | OFFSET1.             |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| O     | Offset    | C | \* |     |      | The name of an       | P |
| FFGRP | Group     | h |    |     |      | Offset Group, either | e |
|       | Name      | a |    |     |      | a Periodic Offset    | r |
|       |           | r |    |     |      | Group, or a          | m |
|       |           |   |    |     |      | non-periodic Offset  |   |
|       |           |   |    |     |      | Group.               |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| V     | Name      | C | \* |     |      | The name of a Visit, |   |
| ISWIN | Visit,    | h |    |     |      | Visit Group, or      |   |
|       | Visit     | a |    |     |      | Window               |   |
|       | Group, or | r |    |     |      |                      |   |
|       | Window    |   |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| A     | Name of   | C |    |     |      | The name of a Trial  |   |
| NCHOR | Trial     | h |    |     |      | Anchor, or of a      |   |
|       | Anchor or | a |    |     |      | Periodic Anchor      |   |
|       | Periodic  | r |    |     |      | Group                |   |
|       | Anchor    |   |    |     |      |                      |   |
|       | Group     |   |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| ORDER | Order of  | N |    |     |      | Order of this        | P |
|       | Activity  | u |    |     |      | activity within a    | e |
|       |           | m |    |     |      | Visit or Window.     | r |
|       |           |   |    |     |      |                      | m |
+-------+-----------+---+----+-----+------+----------------------+---+
| ARMCD | Arm Code  | C |    |     |      | Short 8-character    | P |
|       |           | h |    |     |      | name for ARM, used   | e |
|       |           | a |    |     |      | for programming.     | r |
|       |           | r |    |     |      |                      | m |
+-------+-----------+---+----+-----+------+----------------------+---+
| I     | Condition | C |    |     |      | Statement of         | P |
| FCOND | for       | h |    |     |      | condition under      | e |
|       | P         | a |    |     |      | which activity will  | r |
|       | erforming | r |    |     |      | be performed.        | m |
|       | Activity  |   |    |     |      | Statement will start |   |
|       |           |   |    |     |      | with \"If\". If      |   |
|       |           |   |    |     |      | possible, the        |   |
|       |           |   |    |     |      | condition will be    |   |
|       |           |   |    |     |      | expressed using      |   |
|       |           |   |    |     |      | variable names and   |   |
|       |           |   |    |     |      | values that would    |   |
|       |           |   |    |     |      | occur in the subject |   |
|       |           |   |    |     |      | domains of the SDTM. |   |
+-------+-----------+---+----+-----+------+----------------------+---+

Questions

-   What should the domain code for this dataset be? I have suggested SA
    (for Schedule of Activities).

-   Should the name of this dataset by \"Schedule of Activities\" to
    match the proposed domain code?

-   Does this dataset need ARM, in addition to ARMCD?

Assumptions/Conventions:

-   Descriptions such as \"pre-dose\" which do not include an offset or
    range of offsets, should be used only within the context of a Visit
    or Window. In this context, they can be represented in the Trial
    Activities dataset by means of Order numbers. E.g., the pre-dose
    assessment in a visit could be assigned an order of 1, and the dose
    could be assigned an order of 2.

-   When the order between activities can be inferred from their
    offsets, it is not necessary to also assign order numbers.

## Examples of Records in Trial Activities Dataset

This section gives examples of rows in a Trial Activities Dataset. In
the table, heavy lines mark activities in the same visit, as Order
Variables apply to activities within a visit. Note that there are study
drug activities (records) for each arm of the study.

<table>
<colgroup>
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 13%" />
<col style="width: 19%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>ANAME</strong></td>
<td><strong>OFFSET</strong></td>
<td><strong>OFFSET2</strong></td>
<td><strong>OFFGRP</strong></td>
<td><strong>VISWIN</strong></td>
<td><strong>ANCHOR</strong></td>
<td><strong>ORDER</strong></td>
<td><strong>ARM</strong></td>
<td><strong>IFCOND</strong></td>
<td><strong>Notes</strong></td>
</tr>
<tr class="even">
<td>IE</td>
<td></td>
<td></td>
<td></td>
<td>SCREENING</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>PREGTEST</td>
<td></td>
<td></td>
<td></td>
<td>SCREENING</td>
<td></td>
<td></td>
<td></td>
<td>If SEX=F and of childbearing potential</td>
<td></td>
</tr>
<tr class="even">
<td>VS2</td>
<td></td>
<td></td>
<td></td>
<td>SCREENING</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>SS</td>
<td></td>
<td></td>
<td>DAILY</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>DAILY is name of an offset group used for a daily diary of
symptoms</td>
</tr>
<tr class="even">
<td>VS2</td>
<td></td>
<td></td>
<td></td>
<td>PER1DAY1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td rowspan="3">Three repetitions of Vital Signs, before pre-dose PK
sample.</td>
</tr>
<tr class="odd">
<td>VS2</td>
<td></td>
<td></td>
<td></td>
<td>PER1DAY1</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>VS2</td>
<td></td>
<td></td>
<td></td>
<td>PER1DAY1</td>
<td></td>
<td>3</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>PKCNC</td>
<td></td>
<td></td>
<td></td>
<td>PER1DAY1</td>
<td></td>
<td>4</td>
<td></td>
<td></td>
<td>Pre-dose PK sample.</td>
</tr>
<tr class="even">
<td>PLACEBO</td>
<td>0</td>
<td></td>
<td></td>
<td>PER1DAY1</td>
<td>PER1DOS1</td>
<td>5</td>
<td>P-5-10</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="odd">
<td>DRUG5</td>
<td>0</td>
<td></td>
<td></td>
<td>PER1DAY1</td>
<td>PER1DOS1</td>
<td>5</td>
<td>5-P-10</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="even">
<td>DRUG5</td>
<td>0</td>
<td></td>
<td></td>
<td>PER1DAY1</td>
<td>PER1DOS1</td>
<td>5</td>
<td>5-10-P</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="odd">
<td>PKCNC</td>
<td></td>
<td></td>
<td>PROFILE1</td>
<td>PER1DAY1</td>
<td>PER1DOS1</td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>PLACEBO</td>
<td></td>
<td></td>
<td>PER1D2-4</td>
<td></td>
<td>PER1DOS1</td>
<td></td>
<td>P-5-10</td>
<td></td>
<td rowspan="3">PER1D2-4 is an offset group that contains the offsets
1D, 2D, 3D, and so provides the timing for the Day 2, 3, and 4 doses,
which are not given during a Visit.</td>
</tr>
<tr class="odd">
<td>DRUG5</td>
<td></td>
<td></td>
<td>PER1D2-4</td>
<td></td>
<td>PER1DOS1</td>
<td></td>
<td>5-P-10</td>
<td></td>
</tr>
<tr class="even">
<td>DRUG5</td>
<td></td>
<td></td>
<td>PER1D2-4</td>
<td></td>
<td>PER1DOS1</td>
<td></td>
<td>5-10-P</td>
<td></td>
</tr>
<tr class="odd">
<td>PKCNC</td>
<td></td>
<td></td>
<td></td>
<td>PER1DAY5</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td>Pre-dose PK sample.</td>
</tr>
<tr class="even">
<td>PLACEBO</td>
<td>0</td>
<td></td>
<td></td>
<td>PER1DAY5</td>
<td>PER1DOS5</td>
<td>2</td>
<td>P-5-10</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="odd">
<td>DRUG5</td>
<td>0</td>
<td></td>
<td></td>
<td>PER1DAY5</td>
<td>PER1DOS5</td>
<td>2</td>
<td>5-P-10</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="even">
<td>DRUG5</td>
<td>0</td>
<td></td>
<td></td>
<td>PER1DAY5</td>
<td>PER1DOS5</td>
<td>2</td>
<td>5-10-P</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="odd">
<td>PKCNC</td>
<td></td>
<td></td>
<td>PROFILE2</td>
<td>PER1DAY5</td>
<td>PER1DOS5</td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>PKCNC</td>
<td></td>
<td></td>
<td></td>
<td>PER2DAY1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td>Pre-dose PK sample.</td>
</tr>
<tr class="odd">
<td>DRUG5</td>
<td>0</td>
<td></td>
<td></td>
<td>PER2DAY1</td>
<td>PER2DOS1</td>
<td>2</td>
<td>P-5-10</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="even">
<td>PLACEBO</td>
<td>0</td>
<td></td>
<td></td>
<td>PER2DAY1</td>
<td>PER2DOS1</td>
<td>2</td>
<td>5-P-10</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="odd">
<td>DRUG10</td>
<td>0</td>
<td></td>
<td></td>
<td>PER2DAY1</td>
<td>PER2DOS1</td>
<td>2</td>
<td>5-10-P</td>
<td></td>
<td>Dose</td>
</tr>
<tr class="even">
<td>PKCNC</td>
<td></td>
<td></td>
<td>PROFILE1</td>
<td>PER2DAY1</td>
<td>PER2DOS1</td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>DRUG5</td>
<td></td>
<td></td>
<td>PER2D2-4</td>
<td></td>
<td>PER2DOS1</td>
<td></td>
<td>P-5-10</td>
<td></td>
<td rowspan="3">PER2D2-4 is an offset group that contains the offsets
1D, 2D, 3D, and so provides the timing for the Day 2, 3, and 4 doses,
which are not given during a Visit.</td>
</tr>
<tr class="even">
<td>PLACEBO</td>
<td></td>
<td></td>
<td>PER2D2-4</td>
<td></td>
<td>PER2DOS1</td>
<td></td>
<td>5-P-10</td>
<td></td>
</tr>
<tr class="odd">
<td>DRUG10</td>
<td></td>
<td></td>
<td>PER2D2-4</td>
<td></td>
<td>PER2DOS1</td>
<td></td>
<td>5-10-P</td>
<td></td>
</tr>
<tr class="even">
<td>PKCNC</td>
<td></td>
<td></td>
<td></td>
<td>PER2DAY5</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td>Pre-dose PK sample.</td>
</tr>
<tr class="odd">
<td>DRUG5</td>
<td>0</td>
<td></td>
<td></td>
<td>PER2DAY5</td>
<td>PER2DOS5</td>
<td>2</td>
<td></td>
<td></td>
<td>Dose</td>
</tr>
<tr class="even">
<td>PLACEBO</td>
<td>0</td>
<td></td>
<td></td>
<td>PER2DAY5</td>
<td>PER2DOS5</td>
<td>2</td>
<td></td>
<td></td>
<td>Dose</td>
</tr>
<tr class="odd">
<td>DRUG10</td>
<td>0</td>
<td></td>
<td></td>
<td>PER2DAY5</td>
<td>PER2DOS5</td>
<td>2</td>
<td></td>
<td></td>
<td>Dose</td>
</tr>
<tr class="even">
<td>PKCNC</td>
<td></td>
<td></td>
<td>PROFILE2</td>
<td>PER2DAY5</td>
<td>PER2DOS5</td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>…</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>Items for Period 3 not shown</td>
</tr>
<tr class="even">
<td>QS1</td>
<td></td>
<td></td>
<td></td>
<td>FOLLOWUP</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td rowspan="2"><p>QS1 to be done</p>
<p>before QS2</p></td>
</tr>
<tr class="odd">
<td>QS2</td>
<td></td>
<td></td>
<td></td>
<td>FOLLOWUP</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

## Trial Visits

This existing dataset defines another basic layer of the trial\'s timing
structure.

**One record per Planned Trial Visit**

  ------------------------------------------------------------------------------------------------------------------
  **Variable   **Variable     **Type**   **Controlled   **Origin**   **Role**     **CDISC Notes**         **Core**
  Name**       Label**                   Terms or                                                         
                                         Format**                                                         
  ------------ -------------- ---------- -------------- ------------ ------------ ----------------------- ----------
  STUDYID      Study          Char                      CRF          Identifier   Unique identifier for a Req
               Identifier                                                         study within the        
                                                                                  submission.             

  DOMAIN       Domain         Char       \*                                       Two-character           Req
               Abbreviation                                                       abbreviation for the    
                                                                                  domain, which must be   
                                                                                  TV.                     

  VISIT        Visit Name     Char        \*                                                              Req

  VISITNUM     Visit Sequence Char                                                                        
               Number                                                                                     

  VISITDY      Planned Study  Num                                                                         
               Day of Visit                                                                               

  ARMCD        Planned Arm    Char       \*                                                               
               Code                                                                                       

  ARM          Description of Char       \*                                                               
               Planned Arm                                                                                

  TVSTRL       Visit Start    Char                                                                        
               Rule                                                                                       

  TVENRL       Visit End Rule Char                                                                        
  ------------------------------------------------------------------------------------------------------------------

Issues/Questions:

-   I think TVSTRL should be populated with an Anchor and Offset. Any
    times when this would not work?

Assumptions/Conventions:

-   One of TEENRL and TEDUR must be populated.

## Visit Groups

If many visits collect the same data, it may be convenient to define
visit groups.

**One record per** visit

  ------------------------------------------------------------------------------------------------------------------
  **Variable   **Variable     **Type**   **Controlled   **Origin**   **Role**     **CDISC Notes**         **Core**
  Name**       Label**                   Terms or                                                         
                                         Format**                                                         
  ------------ -------------- ---------- -------------- ------------ ------------ ----------------------- ----------
  STUDYID      Study          Char                      CRF          Identifier   Unique identifier for a Req
               Identifier                                                         study within the        
                                                                                  submission.             

  DOMAIN       Domain         Char       \*                                       Two-character           Req
               Abbreviation                                                       abbreviation for the    
                                                                                  domain, which must be   
                                                                                  VG?                     

  VISGRP       Name of Visit  Char       \*                                                               Req
               Group                                                                                      

  VISIT        Visit Name     Char                                                                        Req
  ------------------------------------------------------------------------------------------------------------------

Issues/Questions:

-   What should the domain code for this dataset be? I have suggested
    VG.

-   If most, but not all, of the activities for a set of visits are the
    same, is it okay to set up a Visit Group for those activities, but
    to specify additional activities visit by visit?

-   Should grouping of visits be incorporated into the Trial Visits
    dataset, rather than being done as a separate dataset? This approach
    would be more similar to the approach in the Planned Activities
    dataset.

Assumptions/Conventions:

-   Visit groups are optional.

-   A visit group will only be useful if there is at least one
    assessment that is performed at all visits in the group.

## Trial Windows

Defines and names windows for data collection. When used in conjunction
with Unplanned Interventions or Events, the record in the Trial
Activities table means that all of the named type of unplanned
interventions or events that occur during the window are to be recorded.
When used in conjunction with Findings or Planned Interventions, the
record in the Trial Activities table means that the activities are to be
performed during the Window, subject to the constraints of their Order
numbers.

**One record per Planned Trial Window**

  ------------------------------------------------------------------------------------------------------------------
  **Variable   **Variable     **Type**   **Controlled   **Origin**   **Role**     **CDISC Notes**         **Core**
  Name**       Label**                   Terms or                                                         
                                         Format**                                                         
  ------------ -------------- ---------- -------------- ------------ ------------ ----------------------- ----------
  STUDYID      Study          Char                      CRF          Identifier   Unique identifier for a Req
               Identifier                                                         study within the        
                                                                                  submission.             

  DOMAIN       Domain         Char       \*                                       Two-character           Req
               Abbreviation                                                       abbreviation for the    
                                                                                  domain, which must be   
                                                                                  TW?                     

  WINDOW       Window Name    Char        \*                                                              Req

  WINDOWCD     Window Code    Char                                                                        

  ARMCD        Planned Arm    Char       \*                                       Used when data          Perm
               Code                                                               collection Windows      
                                                                                  depend on ARM.          

  ARM          Description of Char       \*                                       Used when data          Perm
               Planned Arm                                                        collection Windows      
                                                                                  depend on ARM.          

  STANCHOR     Anchor for     Char       \*                                       Value must be taken     Req
               start of                                                           from Trial Anchors      
               window                                                             table.                  

  STOFFSET     Offset for     Char       ISO8601                                  May be 0.               Req
               start of                                                                                   
               window                                                                                     

  ENANCHOR     Anchor for end Char       \*                                       Value must be taken     Req
               of window                                                          from Trial Anchors      
                                                                                  table.                  

  ENOFFSET     Offset for end Char       ISO8601                                  May be 0.               Req
               of window                                                                                  
  ------------------------------------------------------------------------------------------------------------------

Issues/Questions:

-   What should the domain code for this dataset be? I have suggested
    TW.

-   Do we really need both a Window Name and a Window Code?

-   Evaluation Intervals that have a beginning and an end have the same
    structure as Windows. Should they be defined in the Trial Windows
    dataset, or in a separate Evaluation Intervals dataset?

-   Should one dataset be used for defining Visits, Windows, and
    Evaluation Intervals? With perhaps a flag that indicates which
    records are Visits, which are Windows, which are Evaluation
    Intervals?

Assumptions/Conventions:

-   Windows are optional.

## Trial Anchors

Defines and names any anchors needed.

An anchor should be named only if it is needed to describe a time point
used in the trial state machine or the trial activities table. If a time
point can be described by referencing another Anchor and specifying an
offset, and is not needed as a reference by some other time point, then
it should not be declared as an Anchor.

The most commonly used anchors in drug trials are doses of study drug.
There is often a circular relationship between doses of study drug which
mark the beginning of an Epoch.

**One record per anchor**

  ------------------------------------------------------------------------------------------------------------------
  **Variable   **Variable     **Type**   **Controlled   **Origin**   **Role**     **CDISC Notes**         **Core**
  Name**       Label**                   Terms or                                                         
                                         Format**                                                         
  ------------ -------------- ---------- -------------- ------------ ------------ ----------------------- ----------
  STUDYID      Study          Char                      CRF          Identifier   Unique identifier for a Req
               Identifier                                                         study within the        
                                                                                  submission.             

  DOMAIN       Domain         Char       \*                                       Two-character           Req
               Abbreviation                                                       abbreviation for the    
                                                                                  domain, which must be   
                                                                                  TN?                     

  ANCHOR       Name of Anchor Char                                   Identifier   Name given to an action Req
                                                                                  which serves as a       
                                                                                  reference for timing of 
                                                                                  parts of the study      
                                                                                  design.                 

  ANCHDESC     Description of Char                                                Description of Anchor,  Req
               Anchor                                                             to include a verifiable 
                                                                                  Trial Anchor Event.     
                                                                                  Participants must be    
                                                                                  able to observe and     
                                                                                  record the time of the  
                                                                                  Trial Anchor Event.     
  ------------------------------------------------------------------------------------------------------------------

Issues/Questions:

-   What should the domain code for this dataset be? I have suggested TN
    for [T]{.underline}rial A[n]{.underline}chors.

Assumptions:

-   

## Offset groups

This dataset defines groups of offsets that are used together. If the
group offsets is used only once in a trial, an offset group may or may
not be defined. There is no need to define groups of one. Note that a
reference anchor is NOT included in the Offset Group. The Offset Group
and Anchor come together in the Trial Activities dataset.

**One record per timepoint**

  ------------------------------------------------------------------------------------------------------------------
  **Variable   **Variable     **Type**   **Controlled   **Origin**   **Role**     **CDISC Notes**         **Core**
  Name**       Label**                   Terms or                                                         
                                         Format**                                                         
  ------------ -------------- ---------- -------------- ------------ ------------ ----------------------- ----------
  STUDYID      Study          Char                      CRF          Identifier   Unique identifier for a Req
               Identifier                                                         study within the        
                                                                                  submission.             

  DOMAIN       Domain         Char       \*                                       Two-character           Req
               Abbreviation                                                       abbreviation for the    
                                                                                  domain, which must be   
                                                                                  OG?                     

  OGNAME       Name of Offset Char                                                Name given to a group   Req
               Group                                                              of timepoints, all of   
                                                                                  which share the same    
                                                                                  planned fixed           
                                                                                  reference.              

  TPT          Planned        Char                                                1\. Text Description of 
               Timepoint Name                                                     time when an assessment 
                                                                                  will be made.\          
                                                                                  2. This is represented  
                                                                                  as an elapsed time      
                                                                                  relative to a fixed     
                                                                                  reference point, such   
                                                                                  as time of last dose.   
                                                                                  See TPTREF in Trial     
                                                                                  Assessments.            

  TPTNUM       Planned        Num                                                 Numerical version of    
               Timepoint                                                          TPT to aid in sorting.  
               Number                                                                                     

  ELTM         Elapsed Time   Char       ISO 8601                                 Elapsed time (in ISO    Req
                                                                                  8601) format relative   
                                                                                  to the planned fixed    
                                                                                  reference. Not a clock  
                                                                                  time.                   
  ------------------------------------------------------------------------------------------------------------------

Questions

-   Are both TPT and TPTNUM needed? Is this where they are both defined?

-   ELTM is a timing variable from SDTM. \"Offset\" is the terminology
    used throughout this document. Are \"elapsed time\" and \"offset
    really the same thing; should they have a single name?

Assumptions/Conventions:

##  Periodic Offset Group

This dataset defines a group of offsets based on a common period. For
example, the series of offsets {1D, 2D, 3D, ..., 28D} is a periodic
offset group with a period of 1 day. A Periodic Offset Group is used in
conjunction with an Anchor in the Trial Activities table, in the same
way that a (non-periodic) Offset Group is used.

**One record per periodic offset group**

+-------+-----------+---+----+-----+------+----------------------+---+
| **Var | *         | * | ** | *   | **Ro | **CDISC Notes**      | * |
| iable | *Variable | * | Co | *Or | le** |                      | * |
| N     | Label**   | T | nt | igi |      |                      | C |
| ame** |           | y | ro | n** |      |                      | o |
|       |           | p | ll |     |      |                      | r |
|       |           | e | ed |     |      |                      | e |
|       |           | * | T  |     |      |                      | * |
|       |           | * | er |     |      |                      | * |
|       |           |   | ms |     |      |                      |   |
|       |           |   | or |     |      |                      |   |
|       |           |   | Fo |     |      |                      |   |
|       |           |   | rm |     |      |                      |   |
|       |           |   | at |     |      |                      |   |
|       |           |   | ** |     |      |                      |   |
+=======+===========+===+====+=====+======+======================+===+
| ST    | Study     | C |    | CRF | Id   | Unique identifier    | R |
| UDYID | I         | h |    |     | enti | for a study within   | e |
|       | dentifier | a |    |     | fier | the submission.      | q |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| D     | Domain    | C | \* |     |      | Two-character        | R |
| OMAIN | Abb       | h |    |     |      | abbreviation for the | e |
|       | reviation | a |    |     |      | domain, which must   | q |
|       |           | r |    |     |      | be PO?               |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| O     | Name of   | C |    |     |      | Name given to a      | R |
| GNAME | Offset    | h |    |     |      | group of timepoints, | e |
|       | Group     | a |    |     |      | all of which share   | q |
|       |           | r |    |     |      | the same planned     |   |
|       |           |   |    |     |      | fixed reference.     |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| INO   | Offset    | C | I  |     |      |                      | R |
| FFSET | relative  | h | SO |     |      |                      | e |
|       | to        | a | 86 |     |      |                      | q |
|       | Initial   | r | 01 |     |      |                      |   |
|       | Anchor    |   |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| P     | Period    | C | I  |     |      | Must be positive.    | R |
| ERIOD | for       | h | SO |     |      | May not be a range.  | e |
|       | Periodic  | a | 86 |     |      |                      | q |
|       | Offset    | r | 01 |     |      |                      |   |
|       | Group     |   |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| PO    | End Rule  | C |    |     |      | Rule for ending the  | R |
| GENRL | for       | h |    |     |      | Periodic Offset      | e |
|       | Periodic  | a |    |     |      | Group.               | q |
|       | Offset    | r |    |     |      |                      |   |
|       | Group     |   |    |     |      | May be a fixed       |   |
|       |           |   |    |     |      | number of            |   |
|       |           |   |    |     |      | repetitions, or a    |   |
|       |           |   |    |     |      | free text            |   |
|       |           |   |    |     |      | description.         |   |
+-------+-----------+---+----+-----+------+----------------------+---+

Issues/Questions:

-   Should we have a POGNUM (number of repetitions), in addition to
    POGENRL, the way we have DUR in addition to other ENRL\'s?

-   I think that either Periodic Offset Groups or Periodic Anchor Groups
    are the natural way to express most dosing, so I haven\'t provided a
    \"Frequency\" or \"Dosing interval\" variable in the Trial
    Activities dataset. Is this okay?

Assumptions/Conventions:

-   Periodic Offset Groups are optional.

> .

## Periodic Anchor Groups

Describes a set of anchors related by a common period. The first anchor
in the series occurs at an initial offset relative to an initial anchor.
If the initial offset is 0, the initial anchor is the first anchor in
the series. The Trial Anchor Event associated with the second anchor in
the series is supposed to occur at the period of the series after the
time of occurrence of the first Trial Anchor Event. Each Trial Anchor
Event is supposed to occur period after the time of the last Trial
Anchor Event.

**One record per periodic anchor group**

+-------+-----------+---+----+-----+------+----------------------+---+
| **Var | *         | * | ** | *   | **Ro | **CDISC Notes**      | * |
| iable | *Variable | * | Co | *Or | le** |                      | * |
| N     | Label**   | T | nt | igi |      |                      | C |
| ame** |           | y | ro | n** |      |                      | o |
|       |           | p | ll |     |      |                      | r |
|       |           | e | ed |     |      |                      | e |
|       |           | * | T  |     |      |                      | * |
|       |           | * | er |     |      |                      | * |
|       |           |   | ms |     |      |                      |   |
|       |           |   | or |     |      |                      |   |
|       |           |   | Fo |     |      |                      |   |
|       |           |   | rm |     |      |                      |   |
|       |           |   | at |     |      |                      |   |
|       |           |   | ** |     |      |                      |   |
+=======+===========+===+====+=====+======+======================+===+
| ST    | Study     | C |    | CRF | Id   | Unique identifier    | R |
| UDYID | I         | h |    |     | enti | for a study within   | e |
|       | dentifier | a |    |     | fier | the submission.      | q |
|       |           | r |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| D     | Domain    | C | \* |     |      | Two-character        | R |
| OMAIN | Abb       | h |    |     |      | abbreviation for the | e |
|       | reviation | a |    |     |      | domain, which must   | q |
|       |           | r |    |     |      | be PN?               |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| A     | Name of   | C |    |     |      | Name given to a      | R |
| GNAME | Anchor    | h |    |     |      | group of timepoints, | e |
|       | Group     | a |    |     |      | all of which share   | q |
|       |           | r |    |     |      | the same planned     |   |
|       |           |   |    |     |      | fixed reference.     |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| INA   | Anchor to |   |    |     |      | This is the same as  |   |
| NCHOR | which the |   |    |     |      | the first anchor in  |   |
|       | Intial    |   |    |     |      | the group if and     |   |
|       | Anchor of |   |    |     |      | only if INOFFSET=0.  |   |
|       | the       |   |    |     |      |                      |   |
|       | Periodic  |   |    |     |      |                      |   |
|       | Group is  |   |    |     |      |                      |   |
|       | tied      |   |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| INO   | Offset    | C | I  |     |      |                      | R |
| FFSET | relative  | h | SO |     |      |                      | e |
|       | to        | a | 86 |     |      |                      | q |
|       | Initial   | r | 01 |     |      |                      |   |
|       | Anchor    |   |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| P     | Period    | C | I  |     |      | Must be positive.    | R |
| ERIOD | for       | h | SO |     |      |                      | e |
|       | Periodic  | a | 86 |     |      |                      | q |
|       | Anchor    | r | 01 |     |      |                      |   |
|       | Group     |   |    |     |      |                      |   |
+-------+-----------+---+----+-----+------+----------------------+---+
| PA    | End Rule  | C |    |     |      | Rule for ending the  | R |
| GENRL | for       | h |    |     |      | Periodic Anchor      | e |
|       | Periodic  | a |    |     |      | Group.               | q |
|       | Anchor    | r |    |     |      |                      |   |
|       | Group     |   |    |     |      | May be a fixed       |   |
|       |           |   |    |     |      | number of            |   |
|       |           |   |    |     |      | repetitions, or a    |   |
|       |           |   |    |     |      | free text            |   |
|       |           |   |    |     |      | description.         |   |
+-------+-----------+---+----+-----+------+----------------------+---+

Issues/Questions:

-   Should we have a PAGNUM (number of repetitions), in addition to
    PAGENRL, the way we have DUR in addition to other ENRL\'s?

-   I think Period could be a range, in which case, we probably need a
    PERIOD2 variable, to hold the second half of the range description.

-   I have included the Initial Anchor in this group, but not in the
    Periodic Offset List. I think this makes sense, since this is an
    Anchor group, so I don\'t expect it to be reused with different
    Anchors, the way an Offset Group would be. Okay?

Assumptions/Conventions:

-   Periodic Anchor Groups are optional.

-   Anchors implicit in the Periodic Anchor Group do not also have to be
    listed in the Trial Anchors table.

# General Issues

The following issues and questions are general, rather than related to
particular datasets.

Issues/Questions:

-   Do the new datasets allow description of all protocol information on
    scheduling of activities?

-   If there are gaps, should the model be expanded to cover them?
    Suggestions on how to do this?

-   The model now has the fourteen study-level datasets listed below to
    describe the \"trial schema\" and \"schedule of activities\"
    information in a protocol. The largest group of datasets defines
    ways to describe timing -- are there more elegant, compact ways to
    model this information?

    -   3 datasets that describe the trial state machine (Trial
        Elements, Arm Segments, and Arms)

    -   2 datasets that describe what is done (Planned Activities and
        Regimens)

    -   1 dataset that allows definition of a qualifier, Evaluation
        Windows

    -   7 datasets that define ways to describe when things are done
        (Trial Visits, Trial Windows, Visit Groups, Trial Anchors,
        Offset Groups, Periodic Offset Groups, and Periodic Anchor
        Groups)

    -   1 dataset for the schedule of activities, the Trial Activities
        dataset

# Feedback

Feedback on the particular Issues and Questions in this document, and on
any other part of this proposal, is welcome.

Testing of the model on real protocols, and feedback on what worked and
what didn\'t work, will be extremely valuable.

\[How to submit comments, deadline for submitting comments.\]