4 Radnor Corporate Center
Suite 350
Radnor, PA 19087
+1 (888) 507-2270
OpenCDISC 1.2.1 & 1.3 (FDAs Use)
Forums: General Discussion
Re: OpenCDISC 1.2.1 & 1.3 (FDA's use)
Hi Mike,
I don't want to speak for FDA, so it’s better to direct this question to them. You can email them at cder-edata@fda.hhs.gov (CDER) or cber.cdisc@fda.hhs.gov (CBER).
Max
Re: OpenCDISC 1.2.1 & 1.3 (FDA's use)
Hi Max,
Thank you for the reply back. I did email both addresses and currently awaiting a response back from each division.
Mike
OpenCDISC FDA [Update]
All,
FDA had indicated that OpenCDISC v.1.2 is currently being used, but 1.2.1 was also inclusive due to the bug fixes. However, 1.3 has not been officially tested and current business and technical rules are being validated. No actual release date in its official use was noted. Disclaimer: It's should be checked with your review division prior to submission on obtaining up-to-date information on technical questions.
Hope this helps!
I would be VERY cautious
You cannot expect to get the answer for such questions on public forums. People, who are working for FDA, may not disclosure information.
I would be VERY cautious about the statement, that FDA is actually using v1.2 now, which is 2 year old.
My advice is always to use the most recent available versions to avoid unexpected surprises.
Sergiy Sirichenko /OpenCDISC
FDA SDS Page
All,
As Sergiy has indicated, each submission needs to discuss this with their respective review division. It will vary from that aspect. However, the FDA has provided those standards to the public (refer to link below). I have had emails with the agency regarding reviwer guides and the reporting of errors/warnings. Essentially, if the sponsor uses version X and agency Y, then the reports will have differentiating findings. The goal here is to bring this to the open for discussions. Validation departments cannot always keep up with the newest versions, espcially if projects are already utilizing a set version. Apprecaite everyone's comments!
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm
Hi All,
I'm wondering if the FDA would be confused in receiving 1.3 output error/warning reports? Essentially, the FDA Study Data Standards page for OpenCDISC business/technical validation (config-sdtm-3.1.2-v1.2), which I believe is based on OpenCDISC 1.2, but correct me if I'm wrong. Therefore, the use of OpenCDISC 1.2 and possibly 1.2.1 (same technical/business checks) would suffice. As such, the additional checks found in 1.3 would cause more confusion if relayed back to the FDA within the submission under the reviewersguide.pdf. Anyone else know what version has been okayed by the FDA?
Greatly appreciated!