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lechia ☆ C of U, 2016-09-19 23:37 (2768 d 09:20 ago) Posting: # 16650 Views: 6,815 |
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Hi all, Starting in December all BE studies will require data to be submitted in CDISC format. I was wondering if anyone knew what is specifically required? Are SDTM, i.e. PC and PP datasets sufficient or do we need to provide the AdAM datasests ADPC and ADPP, as well? Thank you. |
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DavidManteigas ★ Portugal, 2016-09-22 12:47 (2765 d 20:10 ago) @ lechia Posting: # 16665 Views: 5,931 |
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Hi lechia, Please, take a look at the Study data technical conformance guide. It is quite clear on what and how you should submit. http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf ADaM datasets are necessary for the analysis of the primary objective (Bioequivalence) so at least ADSL and ADPP should be submitted imo. It is up to you to decide wheter you need additonal ADaM datasets, just keep in mind that ADaM datasets purpose is to facilitate the review in case of SDTM domains require a lot of programing to generate the output of the primary objectives (tranpose, etc). If the ADaM dataset is just a "copy" of the SDTM domain with less variables and different variable names, I would use SDTM instead. |
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lechia ☆ C of U, 2016-11-22 23:33 (2704 d 08:24 ago) @ DavidManteigas Posting: # 16807 Views: 5,292 |
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Thank you for your response, David. A related question is whether pilot studies that are submitted to the FDA along with the pivotal studies for information/completeness purposes must also follow CDISC standards. The guidance says: "... all studies with a start date 24 months after the publication date must use the appropriate FDA-supported standards, formats, and terminologies ... for NDA, ANDA, and certain BLA submissions." Not sure how to interpret this. Would only pivotal studies fit this description or any study since any study done on a particular IP since it would be part of the submission? Presumably this would not matter if a study is ANDA or NDA. Thanks. |
Ing. Helmut Schütz