| Protocol Representation Group
Important Note: The posting package has been revised as of 4 May 2009. The following changes have been made:
- The document “Protocol Representation Model Documentation v1 0 - 29 April 2009.pdf” has been updated to include Study Design and other important concepts, which were inadvertently omitted from the original document.
- The spreadsheet “PRM-BRIDG Mapping 4May2009.xls” has been updated to include a workbook for Version 1.0 elements only and a workbook for all Protocol elements.
- The Enterprise Architect (EA) model file “PRMV1.0 29April2009.EAP” has been included for those reviewers that would like to look at the model in the EA tool. If you don’t have EA and don’t want to purchase it, you can download a free EA viewer from www.sparxsystems.com if you’d like to review the model in the tool rather than reviewing the model in the pdf.
- A printable version of the model diagram “PR Model Overview Diagram V1.0 print view.pdf” has been included in the package for those reviewers who would like to print the model on 8 1/2 x 11 paper. Please note that the model prints on 25 pages of 8 ½ x 11 paper that will then need to be taped together.
The CDISC Protocol Representation Group has now posted the Protocol Representation Model Version 1.0 (PRM V1.0) for review and comment. Please use the comment spreadsheet included in the posting package to provide comments to CDISC by 15 June 2009.
PRM V1.0 is represented in a domain analysis model and includes semantics for Study Design, Clinical Trial Registry, and Eligibility Criteria.
To review the document and register your comments, please click here. (Posted on 16 April 2009)
Status of Study 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 already in ODM, adding information on the timing and conditions for data collection, as well as 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.
See SDTM Trial Design datasets.
See BRIDG Study Design diagram.
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