# Presentation: 075718

## caBIGTM Study Calendar SIG

- Duke University
- January 30-31st, 2006

**Notes:**
Version 3

## Agenda

- Review Mission
- Review Scope
- Review SC SIG Activities
- Discuss Study Calendar Workflow
- Discuss Study Calendar Definitions
- Next Steps

## Goals for the session

- Review the missions and goals of the Study Calendar
- Highlight current and future Study Calendar activities
- Get feedback on definitions and workflow
- Get example/templates for existing protocol schemas

## Mission

- The Study Calendar SIG’s mission is to define/model/create a study calendar for the CTMS workspace that is useful for clinical research

## CTMS Development Goals for 2006

## Goals and scope

- Develop a requirements document which would capture use cases defining the study calendar.
*	**Mayo has given their templates as an example, but we would like this from every clinical trials group.*
- Model the three aspects of the Study Calendar: Template; Forecast; Outcomes
- Integrate with other CTMS activities and BRIDG, and include HL7 v3 messaging
*Develop a caBIG compliant study calendar module*

## Goals and scope

- The Study Calendar model will accommodate:
- Epidemiological (& population) studies
- Observational studies
- Interventional studies

## Study Calendar Model

- Three Aspects (Template, Forecast, Outcomes)
- Accommodate the Study Parameter table any study (also called the schema for the study)
- Represent study workflow in time, process and phases
- The Study Calendar is a subset, but a key subset, in the overall life cycle of a study
- The Study Calendar must be capable of representing event-driven and date-driven ‘behaviors’

## Protocol Lifecycle

- Study Calendar Aspects

- Retrospective Data
- Outcomes

## Protocol Lifecycle - Forecast

## Data definitions

- Screening
- The process of evaluating a subject for eligibility and potential participation in a clinical trial.
- Formal screening begins when consent is obtained (before research-related procedures are performed)
- Ends when a subject is registered to the trial or determined to be ineligible

## Data definitions

- Screening Process

- Informed Consent

- Ineligible or Study Registration

## Data definitions, cont.

- Registration - The formal method of entering a patient onto a given trial, typically described in the protocol.
- Arm - A branch of the protocol design to which study participants are assigned a specific treatment schedule
- Randomization - The process of assigning trial subjects to treatment or control groups (a study Arm) using an element of chance to determine the assignments in order to reduce the bias (ICH 1.48)
- Can occur at registration or at any point thereafter

## Data definitions, cont.

- Active monitoring - The process of monitoring that tests, procedures and other evaluations associated with an arm are appropriately conducted as defined by the protocol.
- Begins with subject registration
- Covers Interventional, Epidemiological and Observational trials
- Ends when all study defined activities/procedures are completed

## Data definitions

- Active Monitoring

- Subject Registration

- Protocol Schedule Complete (tests, QOL, procedures, F2F evaluations)

## Data definitions, cont.

- Long term follow-up - The period that begins when the subject has completed active monitoring until such time that no further data are being collected on the subject.
- Monitored for events, such as death or progression on a regular basis (could be via letter/phone call/record review with LMD, subject or family member)

## Data definitions

- Long Term Follow Up

- Completed Active Monitoring

- Per protocol

## Study Calendar Aspects

- The Template
- A reflection of the study parameter table. It is abstract, specific for each study, and has not been applied to a patient
- The Forecast
- At the point of accrual (or during screening or randomization) the template is used to create a forecast of events for a patient
- Outcomes
- As the patient moves through the study temporally, real dates, times and links to appointment, clinical, lab and pathological data is associated with the patient

## Workflow model

## Workflow model

-  	Time	Process	Phase

## Workflow model

-  	Time	Process	Phase

## CTMS Development Goals for 2006

## Next Steps

- Assemble a ‘library’ of prototypical study schemas/templates for refining requirements
*	**Mayo has given their templates as an example, but we would like this from every clinical trials group.*
- Harmonize the Study Calendar definitions with existing caDSR definitions
- Integrate the harmonized definitions and workflow into BRIDG
*Start application development of a study calendar module, including HL7 v3 messaging*