Study/Trial Design Model

Trial Design Examples are now posted in the members area.

Status of Study/Trial Design

CDISC work on Study Design began as part of the SDS team, and resulted in the Trial Design datasets first introduced in SDTM V1.0 and SDTMIG 3.0.  Study Design has also been in the scope of the Protocol Representation Group since its inception. The TDM (Trial Design Model) team continues to develop concepts in this area, and coordinates study design work occuring in several CDISC and CDISC-HL7 teams.

In October 2005, a proposal for TDM Part 2 was published for public comment.  It included proposals for several SDTM-style datasets which would be used to represent the schedule of activities (planned assessments, interventions, administrative activities, and encounters).  Consideration of the comments received and further thought about the challenges presented by complex scheduling examples led the team to abandon this approach and to concentrate on creating a UML model for study design. That model was harmonized with BRIDG, and study design concepts were included in BRIDG Release 1.1.

Two xml implementations of study design are currently under development, an extension to ODM and an HL7 message.  The first builds on the representation of study data collection definitions already in ODM, adding information on activities, their timing and workflow, as well as inclusion and exclusion criteria, study summary and high-level experimental design information.  The HL7 Study Design message builds on existing HL7 messages and methodolgy for describing workflow, while adding representation of experimental design.

Work on study design within the SDTM framework has been incorporated into SDTM 1.2 and SDTM 3.1.2.  The SEND pilot is utilizing a proposed Trial Sets dataset, and the TDM team is working on generalizing the Trial Visits dataset to other kinds of encounters (e.g., telephone contacts, diary entries) and developing datasets to describe planned timepoints.