Questions & Responses for Data Submissions
| Question | Team Collective Response |
|---|---|
| At one point there was a joint CDISC/FDA team working on defining locations in SDTM/ADaM for BIMO components so that the CLINSITE information could be pulled from the submitted data instead of a separate dataset. This joint effort has currently been put on hold. However, at this point, the team recommends to continue to reference the current BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioresearch-monitoring-technical-conformance-guide https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioresearch-monitoring-technical-conformance-guide) and Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standardized-format-electronic-submission-nda-and-bla-content-planning-bioresearch-monitoring-bimo) for details. | Team Response Dated: 13th August 2020 The team has provided their response to the question on "Requirements for Clinical Site Data and Subject Level Data Listings for FDA CDER's Inspection Process (also called BIMO submission or OSI Pre-NDA request)." in the past. https://www.phusewiki.org/wiki/index.php?title=Requirements_for_Clinical_Site_Data_and_Subject_Level_Data_Listings_for_FDA_CDER%27s_Inspection_Process_(BIMO) |
| These questions are primarily going out to the sub-team that worked on the Best Practices for Submission of Event Adjudication Data Whitepaper. The whitepaper provided very useful tips on how to map adjudicated data to the new custom SDTM domain of EA. The following are the follow-up questions to this whitepaper. Are there any plans of including the EA domain in future CDISC SDTM IG releases? If so, which IG is this being targeted for? Is it ok to assume that sponsors can submit this as a custom domain to regulatory agencies until then? | PHUSE Team Response: 14th July 2020 CDISC SDS informed that the adjudication project is under consideration and may be in the future SDTMIG (beyond SDTMIG v3.4). Submitting EA as a custom domain is allowed by the current SDTMIG. The proposed domain in the whitepaper is based on previous submission experiences and can be used for submission until a new domain is published by the CDISC. The whitepaper did not get into any suggestions on how to map this into ADaM. This may be intentional, as it may depend on the nature of the analysis surrounding adjudicated data or even the type of adjudicated data itself. Is there any general recommendation you can make? PHUSE Team Response: 14th July 2020 For ADaM, a statistical/reporting analysis plan determines which data should go into the analysis datasets and how the data are used for reporting and associated analyses. An example is not included in the whitepaper because, in general, only the final adjudication assessment is included in the ADaM dataset. However, an example of how to capture final assessments in EA domain is provided in the whitepaper. |
| Is exposure data from the parent study required to be in the SDTM data of a follow-up study (no treament given in follow-up study)? Is it required for FDA and PMDA? Can the exposure data be carried over from the parent study SDTM into the follow-up study SDTM data, or does it need to be re-collected on the CRF of the follow-up study? | PHUSE Team Response: 9th January 2020 In general, if the data is not collected on the CRF for the follow up study, then it is not recommended to report that into SDTM datasets. In this example, we recommend not to carry it over to SDTM for the follow up study. Instead, this information can be presented in the analysis dataset. |
| Is there a Standard in the Industry of how they determine the study start date for clinical studies? Is it the protocol finalised date, first subject in date or first initiation date? | PHUSE Team Response: 22nd November 2018 As per the guidance from the FDA - Providing Regulatory Submission in Electronic Format - Standardised Study Data, 'the study start date for clinical studies is the earliest date of informed consent among any subject that enrolled in the study'. For example, see Study Start Date in the SDTM Trial Summary Domain (TSPARMCD = SSTDTC). For nonclinical studies, the study start date is the date on which the study protocol or plan is approved (signed) by the Study Director, also known as the study initiation date. For example, see Study Start Date in the SEND Trial Summary Domain (TSPARMCD = STSTDTC). This definition is consistent with the Study Data Standardised Plan (SDSP) PHUSE template, which is reviewed and authorised for usage. References FDA Guidance, "Providing Regulatory Submissions In Electronic Format —Standardized Study Data” https://www.fda.gov/downloads/Drugs/Guidances/UCM292334.pdf Study Data Standardized Plan PhUSE template https://www.phuse.eu/css-deliverables, direct link to the template: https://www.phuse.eu/documents//sop/wp/phuse-tp001-study-data-standardization-plan-v1-8409.docx |
| Requirements for Clinical Site Data and Subject Level Data Listings for FDA CDER's Inspection Process (also called BIMO submission or OSI Pre-NDA request) | PHUSE Team Response: 26th April 2018 As there is a lot of detailed information here, a new page has been created |