Best Practices for Data Collection Instructions
The development of a Study Data Standardization Plan (SDSP) was identified as a need in recent draft FDA Guidance on Providing Regulatory Submissions in Electronic Format - Standardized Study Data (Final FDA Guidance December 2014). In the Draft Study Data Technical Conformance Guide that accompanies the draft guidance the identification of a Study Data Standardization Plan was highlighted for both non-clinical and clinical studies. (see: UCM384744.pdf).
This team will work on a standardized approach to the development of a Study Data Standardization Plan (SDSP). The goals of the team are to provide a template, instruction, and some examples that may be utilized by sponsors to develop the SDSP. It is expected that the SDSP will support the Clinical Development and Non-Clinical development plans, as well as the Target Product Profile for a particular compound of device.
The Study Data Standardization Plan deliverables have been sent to FDA for the next level of review. They are attached.
Project Leadership Team
|Michael Brennan||Project Leader||ArborSys Group||mbrennan (at) arborsys.com|
|Jane A Lozano||Project Leader||Eli Lilly||lozano_jane_a (at) lilly.com|
|Nhi Beasley||FDA Liaison||FDA||nhi.beasley (at) fda.hhs.gov|
- The SDSP deliverables have been sent to the FDA Champion, Helena Sviglin, who will ensure they are reviewed at the next level. They were received by FDA on March 31, 2016. The team will not meet until the comments have been received from the public review, which is scheduled to occur via a Federal Registry notice after the review period is over for the SEND SDRG.
Objectives and Timelines
|Template Finalized (Ready for CSS Steering Committee Reviw)||End of June, 2015|
|First draft completion guidelines||September 1, 2015|
Project Content and Activities
- The following presentation documents sub-groups and who is currently assigned to the sub-group.
- The following link is to the Lab Units White Paper