+---------+------------------------------------------------------------+
| **Da    | > **Changes/Additions, with Rationale**                    |
| taset** |                                                            |
+---------+------------------------------------------------------------+
| > Trial | > New variable, TETRT, for documenting the treatment       |
| > E     | > associated with an element. This information was         |
| lements | > previously indirectly included in the element start rule |
|         | > (e.g., \"First dose of Drug X.\")                        |
+---------+------------------------------------------------------------+
| > Trial | > New dataset that clarifies the relationship between      |
| > Arm   | > Elements and Epochs. Each arm of the trial is built of   |
| > S     | > \"Arm Segments,\" one for each Epoch of the Trial. An    |
| egments | > Arm Segment may consist of one element or several        |
|         | > elements, and the number of elements in an Epoch need    |
|         | > not be the same for all Arms.                            |
|         | >                                                          |
|         | > Also, Arm Segments are allowed to repeat. RPTRL and      |
|         | > RPTENRL describe the repetition and when it should end.  |
|         | > This provides a better way to handle an indeterminate    |
|         | > numbers of repetitions, as for cycles of chemotherapy.   |
+---------+------------------------------------------------------------+
| > Trial | > Trial Arms are built of Arm Segments instead of          |
| > Arms  | > Elements. However, if each Arm Segment in the trial      |
|         | > consists of exactly one element, this is equivalent to   |
|         | > the current version of the TDM.                          |
|         | >                                                          |
|         | > New variable, TABLGRP, allows description of which arms  |
|         | > are blinded for each Epoch.                              |
+---------+------------------------------------------------------------+
| > Trial | > New variables TVTYP and TVID expand this dataset to      |
| >       | > allow description of subject trial contacts other than   |
|  Visits | > those named as Visits by the protocol (e.g., phone       |
|         | > contacts, contacts with other clinics).                  |
|         | >                                                          |
|         | > New variable IFCOND provides the ability to specify      |
|         | > visits and other subject trail contacts which are not    |
|         | > scheduled for all subjects or under all circumstances.   |
|         | > ARM/ARMCD provide the ability to restrict Visits to      |
|         | > particular Arm(s), but IFCOND provides more general      |
|         | > functionality.                                           |
|         | >                                                          |
|         | > New variables TVRRIND, TVRRPER, and TVRRENRL allow the   |
|         | > description of regularly repeating series of visits or   |
|         | > other subject trial contacts.                            |
+---------+------------------------------------------------------------+
| > S     | > A new dataset that describes the scheduling of           |
| chedule | > activities in the trial. Each record describes a time    |
| > of    | > when a particular Activity Group (e.g., Labs, recording  |
| > Act   | > of AEs) is scheduled. In other words, each record        |
| ivities | > corresponds roughly to an X or check mark in the         |
|         | > Schedule of Activies table (Table of Events, Time and    |
|         | > Events Table) present in most protocols.                 |
|         | >                                                          |
|         | > Activity Groups must be defined in the Activities table. |
|         | >                                                          |
|         | > The scheduling of an Activity Group may be described as  |
|         | >                                                          |
|         | > Being during a visit                                     |
|         | >                                                          |
|         | > Being scheduled at a certain time (an Offset) relative   |
|         | > to an \"Anchor\" (the start or end of an element or      |
|         | > visit, or another trial activity)                        |
|         | >                                                          |
|         | > In a regularly repeating fashion                         |
|         | >                                                          |
|         | > The order of Activity Groups within a Visit or other     |
|         | > subject trial contact may be specified.                  |
+---------+------------------------------------------------------------+
| > Activ | > New dataset that defines the Activity Groups and their   |
| ities\* | > component individual Activities planned for the trial.   |
|         | >                                                          |
|         | > The variable GRPORD allows the order of Activities       |
|         | > within an Activity Group to be specified (e.g., the      |
|         | > order of questions in a questionnaire).                  |
|         | >                                                          |
|         | > Activities Groups and Activities are given names, and    |
|         | > each Activity is further defined by describing it in     |
|         | > SDTM terms, i.e., the Domain in which data from this     |
|         | > activty will be stored, the value of any Topic variable  |
|         | > (e.g., TESTCD), and the values of any pre-specified      |
|         | > Qualifiers (e.g., VSPOS, EXDOSE).                        |
|         | >                                                          |
|         | > A new kind of Qualifier, a Monitoring Interval, may be   |
|         | > used to express the fact that data is to be collected    |
|         | > only for things that happened in a certain time period   |
|         | > (e.g,. Prior Medications restricted to the 30 days       |
|         | > before the start of study drug).                         |
+---------+------------------------------------------------------------+
| >       | > New dataset that allows description of Anchors not       |
| Anchors | > identified elsewhere. Any scheduled activity group, or   |
|         | > the start or end of any element, epoch, visit, or other  |
|         | > subject trial contact may be used as an Anchor. However, |
|         | > activities may also be triggered by unscheduled events,  |
|         | > such as particular adverse events.                       |
+---------+------------------------------------------------------------+
| > Visit | > An optional dataset that gives a name to a group of      |
| > Group | > visits. If multiple visits share the same scheduled      |
|         | > activities, using Visit Groups in the Schedule of        |
|         | > Activities can reduce repetition in that dataset and     |
|         | > emphasize the similarity of the Visits in the Visit      |
|         | > Group.                                                   |
+---------+------------------------------------------------------------+
| >       | > An optional dataset that gives a name to a group of      |
|  Offset | > Offsets. If multiple scheduled activities share the same |
| > Group | > set of Offsets relative to an Anchor or Anchors, then    |
|         | > using Offset Groups in the Schedule of Activities can    |
|         | > reduce repetition in that dataset and emphasize the      |
|         | > similarity of the patterns of offsets for a set of       |
|         | > scheduled activities.                                    |
+---------+------------------------------------------------------------+
| > Mon   | > A new dataset used to define a Monitoring Intervals used |
| itoring | > as Qualifiers in the Schedule of Activities dataset.     |
| > In    | > Monitoring Intervals are used to express the fact that   |
| tervals | > data is to be collected only for things that happened in |
|         | > a certain time period (e.g,. Prior Medications           |
|         | > restricted to the 30 days before the start of study      |
|         | > drug).                                                   |
+---------+------------------------------------------------------------+

\*I\'m not certain what the official name of this dataset should be. In
the October draft it\'s \"Planned Activities\" but that may suggest
scheduling, which I want to avoid. If \"Activities\" is too plan, maybe
\"Definition of Activities\"?