Unless otherwise noted,
the following publications and presentations
are available in in Adobe Acrobat PDF format,
and can be read using the Adobe Acrobat Reader
or by a browser that supports viewing of PDF
files. Download
the free Adobe Acrobat Reader.
FDA Information/Documents Relevant to CDISC
For abstracts of the following, click here.
EMEA Information/Documents Relevant to CDISC
The European Medicines Agency (EMEA) Inspections – Good Clinical Practice
“The Sector draws on the expertise of member states’ inspectorates for the fulfilment of many of its GCP related tasks.
This is primarily achieved through the GCP Inspectors Working Group”. A new Document of Interest has been posted in this EMEA website area.
This document references the CDISC eSource Data Interchange initiative. (http://www.cdisc.org/eSDI/eSDI.pdf)
The Draft Reflection Paper on Expectations for Electronic Source Documents used in Clinical Trials is now available (click here)
This document has been released for consultation until 31 April 2008 and can be found at the following EMEA links.
http://www.emea.europa.eu/Inspections/GCPInspmtg.html
and
http://www.emea.europa.eu/Inspections/WhatsNew.html
CDISC SDTM/ADaM Pilot Project
The CDISC SDTM / ADaM Pilot Project was conducted as a collaborative pilot project with FDA and Industry. (This pilot project is also referred to as “Pilot 1.” It was conducted during 2006 and 2007). The objective of the pilot project was to test how well the submission of CDISC-adherent datasets and associated metadata met the needs and the expectations of both medical and statistical FDA reviewers. In doing this, the project also assessed the data structure, resources and processes needed to transform source data into the SDTM and ADaM formats and to create the associated metadata.
This pilot project effort represented an unprecedented amount of work and collaboration between CDISC, the Industry and FDA and led to a number of valuable learnings, documented in the project report. However, it must be noted that all comments, statements, and opinions attributed in the project report to the regulatory (FDA) review team reflect views of those individuals conveyed as informal feedback to the pilot project team, and must not be taken to represent guidance, policy, or evaluation from the Food and Drug Administration
All of the aforementioned goals were met by the CDISC SDTM/ADaM Pilot Project. The project established that the package submitted using CDISC standards met the needs and the expectations of both medical and statistical reviewers participating on the regulatory review team. The regulatory review team noted the importance of having both data in SDTM format to support the use of FDA review systems and interactive review, and data in ADaM format to support analytic review. The project also demonstrated the importance of having documentation of the data (e.g., the metadata provided in the data definition file) that provides clear, unambiguous communication of the science and statistics of the trial.
The regulatory review team expressed a favorable impression of the pilot submission package. They were optimistic about the impact that data standards will have on the work associated with their review of new drug applications.
Project Report
The project report describes the pilot submission package and the processes followed, including the decisions made to produce the package, and lessons learned from the experiences of the pilot and from feedback from the regulatory review team. Each step of the pilot process and work completed are easily followed in the report beginning with the de-identification of the pilot legacy data, application of CDISC Standards (including SDTM, ADaM, and CRTDDS), and resulting in the creation of a CDISC-compliant electronic clinical study report submission. Comments on this project report can be posted through the CDISC Discussion Board.
Additional pilot project materials available
The revised pilot submission package is available to CDISC members (on the “members-only” section of the CDISC webpage) for use as an example of the application of the CDISC standards.
In addition, various presentations about this pilot project have been made during 2006-2007; those presentations can be found here in the Publications and Presentations section. For example, presentations made during the 2006 CDISC Interchange are available at this location.
eSource Data Interchange (eSDI) Document
The eSDI document is the product of the CDISC eSDI Initiative, the purpose of which was "to investigate the use of electronic technology in the context of existing regulations for the collection of eSource data (including that from eDiaries, EHR, EDC) in clinical trials for regulatory submission by leveraging the power of the CDISC standards, in particular the Operational Data Model (ODM)".
The overarching goals are to make it easier for physicians to conduct clinical research, collecting data only once in an industry standard format for multiple downstream uses, and thereby to improve data quality and patient safety.
The eSDI Document includes:
- An extensive review and analysis of the relevant existing regulations
- Twelve requirements for conducting regulated clinical research using eSource data collection in the context of existing regulations
- Five potential scenarios, three of which include the use of electronic health record systems (EHR), and associated benefits of standards
- An Appendix on Responsibilities of each of the various functional groups conducting clinical research
- A Template for evaluating an eSource data collection process against the requirements
- A Good Practices Checklist for Investigators
Please click here to read the document.
The eClinical Forum and PhRMA
EDC/eSource Taskforce announce the release of
their discussion paper: The
Future Vision of EHR as eSource for Clinical
Research, Version 1 (PDF) (14-Sep-06)
This discussion paper is issued with the intention
of convincing eHealth designers (government
sponsored initiatives) and providers of technology
to support these nationwide initiatives, of
the feasibility and practicality of including
requirements for facilitation of clinical studies
within the Electronic Health Record data structure. The paper identifies the perceived benefits
that implementation of this vision can realize,
and associated regulatory issues, and discusses
interim steps that all stakeholders can do towards
achieving this goal.
The discussion paper, and comments to the initial
draft of this paper (March '06) can be downloaded
from the eClinical Forum website homepage: www.eclinicalforum.co
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