DRM SIAC Paper Destruction Working Group 13 September 2011 v0.2 of Framework for the Destruction of Paper - Feedback and Next Steps DRM SIAC Paper Destruction Working Group 13 September 2011

The Past… The Framework for the Destruction of Paper was sent for broader review within the Working Group companies on August 17th. All feedback that was sent, even after the deadline, was accepted and considered. 9 persons forwarded varying degrees and scope of feedback from their review or their company representative review Drug Information Association www.diahome.org

Feedback was considered both within and across topic teams. The Present… Feedback was collated into a single excel document and distributed to the TTL Feedback Who provided Discussion Action Feedback was considered both within and across topic teams. TTL have completed or are completing the response to each feedback item Drug Information Association www.diahome.org

Feedback Summary – General Receive both comment that the framework is “Comprehensive” and “Not ready for broad review” Bibliographies need to be more precise, following a standard Not only for TMF in an eTMF as it applicable to all clinical trial records in ECMS? Latter. Scary – how can it be organized in a more friendly way Summary Statement that sums the conclusion In preparation by the TTLs Drug Information Association www.diahome.org

Feedback Summary – Technology Received several very good suggestions on Technology parameters and  interpretations Made several modifications to the parameters and added new parameter Not all changes could be accommodated as in several instances it is up to the readers interpretation as to what should/should not be within scope. Drug Information Association www.diahome.org

Feedback Summary – Records Management Evaluated all feedback to assess for RM position/impact Still 4 items to have further discussion Glossary updated and more coming Parameters -several reworded to make more clear or isolate to our current topic Drug Information Association www.diahome.org

Feedback Summary - Regulatory Validation of Systems Origin - Information Technology SVP Felt that parameters surrounding system validation needed more development Action - It was decided in the TTL this needed to handled through technology team Varied Feedback Minor grammatical edits but no substantial changes to proposed content of parameters Action - Updated as described Drug Information Association www.diahome.org

Feedback Summary - Legal Agreement that the framework can be distributed for broader review Update of scope Discussion about “industry opinion” Of the industry representatives polled, only one response indicated that their organization has a documented position on such a process.  That position is that it is permissible to destroy paper copies once an agreed framework is in place.  The details provided are in alignment with our proposed framework.  The collective team was aware of at least one other company that implemented such a framework but that company would not agree to be on record – thus not formally cited. Drug Information Association www.diahome.org

Feedback Summary - Quality 12 minor updates made to quality parameters Rewording Clarification about certification 2 no actions 1 deletion (of text only from a reference only) Drug Information Association www.diahome.org

TBD is when Regulators will be invited to review. The Future… Version 0.2 is to be soon ready (end of September or earlier) for broader release to DRM SIAC members and beyond such as professional groups, for feedback. TBD is when Regulators will be invited to review. Feedback will taken for 30 days and then considered for another 30 days. It is the intent to release v1.0 of the framework in December 2011 . Feedback mechanism will be included to allow continual feedback. Version 1.1 or 2.0 (depending on severity of changes) in 2012. Drug Information Association www.diahome.org

To Become Involved in this Initiative… To become involved with the continued enhancement and maintenance of this framework: Contact the DIA DRM SIAC, located on the DIA website www.diahome.org Contact Lisa Mulcahy directly at mulcahy67@comcast.net Join the LinkedIn Group called “TMF Reference Model” and request assistance to connect with this working group, or Drug Information Association www.diahome.org