Our friend and colleague Dawn Edgerton is back again to provide us with more information on changing data standards and FDA submissions. Thank you Dawn for sharing your knowledge and expertise!
What is the SDSP?
The SDSP is a list of planned and completed clinical and nonclinical studies associated with an Investigational New Drug (IND) application. For each study, the sponsor specifies the type of study (ex. Phase I); the study design (ex. cross-over); and the data standards, formats, terminologies along with their versions. Here is an example entry from the FDA website of a clinical study.
When do I submit the SDSP?
In the past, the SDSP would be expected in the briefing package for the End-of-Phase 2 FDA meeting; but the FDA Study Data Technical Conformance Guide recommends sponsors submit a SDSP as part of their IND application and include an updated version with each subsequent meeting package.
Why does the FDA want a SDSP?
The SDSP assists FDA in identifying potential data standardization issues early in the development program. You may submit the SDSP as part of the briefing package and ask the Agency if the plan is acceptable in your list of questions. The Agency will likely respond in written form.
How do I get help filling it out?
The FDA’s Study Data Standards Resources Web page provides recommendations for preparing a SDSP. FDA Study Data Standards Resources
You may also choose to use the template published by the Pharmaceutical Users Software Exchange (PhUSE). PhUSE Wiki SDSP
Remember, a prepared reviewer is a happy reviewer! The SDSP facilitates agreement between the sponsor and the Agency regarding the expectations on data standards.
Dawn M. Edgerton, MBA, RAC