The Trial Design Subteam of the SDS Team and
PR Group released Part 2 of the Trial Design
Model (TDM) for comment in October, 2005. TDM
Part 2 adds functionality to describe the scheduling
of Trial Activities such as assessments, interventions,
and administrative actions. It also provides
a new concept called Trial Arm Segments to describe
trials with dissimilar Arms. The Trial Design
Subteam is revising Part 2 in light of the comments
received and other input, and a new release
is planned for Q3 of 2006. The Trial Design
team is also working on UML diagrams as part
of the BRIDG Model, available at www.bridgproject.org.
Trial Design Model Part 2,
October 12, 2005 (pdf)
TDM Comments Spreadsheet (xls)
Zip file containing both of the above documents
(zip)
Protocol Elements for Regulated
Clinical Trials
| Protocol
Elements Full List 2-0-0.pdf |
This document is Version 2
of the comprehensive protocol elements spreadsheet.
|
| Protocol
Supplements 1-0-0.pdf |
The ICH E6 guidance identifies certain
essential documents that are required for
the conduct of a clinical trial and may
supplement the clinical trial protocol.
The "Protocol Supplements" posted
here is a listing of such documents assembled
by the PR group. Each document has been
listed together with a citation of the section
of the guidance that identifies it (Field
Source column). This Protocol Supplements
list is posted together with the "Protocol
Elements" document so that reviewers
familiar with the various documents that
are frequently part of trial planning and
execution can see clearly which are included
in the protocol itself and which ones are
typically attached to protocols as supplements.
Reviewers may wish to suggest adding other
documents to the list of Protocol Supplements
or comment on removing ones the Protocol
Group has included. |
| PR
Group F2F Presentations 26-27Jan2006.zip
|
This zip file contains presentations from
the 26-27 January 2006 PR Group face-to-face
meeting. |
| PR
and BRIDG DIA EDM Presentations Feb2006.zip
|
This zip file contains presentations from
the February 2006 DIA EDM Conference. |
| DIA
2005 PR Presentations.zip |
This zip file contains DIA Annual Meeting
2005 presentations related to the Protocol.
|
