Questions | Teams 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. | PHUSE Team Response: 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. |
These questions are primarily going out to the sub-team that worked on the Best Practices for Submission of Event Adjudication Data White Paper. The White Paper 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 White Paper.
| PHUSE Team Response: 14th July 2020
|
Is exposure data from the parent study required to be in the SDTM data of a follow-up study (no treatment 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://phuse.global/Deliverables/1, direct link to the template |
What goes in the 'misc' folder with an m5 eCTD folder structure? For example, a lookup file containing SMQ assignment. The file is used during the creation of pooled ADaM to support an ISS. We want to provide this dataset to the reviewer. This does not contain subject’s data and it is not SDTM or ADaM. Should this go to the 'misc' folder? or to the analysis folder and described in the define.xml and classified as non-ADaM? or is it enough to describe its structure in the ADRG?. | PHUSE Team Response: 12th April 2018 Name, page 11-12. Information about these additional files and their use in creating the datasets should be included in the reviewer’s guides. |
Does the legacy data in non-CDISC format need to be converted to SDTM for all studies that are part of the FDA or PMDA submissions? If a sponsor has one pivotal study in non-CDISC and the other pivotal study in CDISC, do I need to convert both to CDISC format before submission?. | PHUSE Team Response: 7th June 2017
For other phase I and CP studies that don’t meet above criteria, electronic data required when PMDA needs them for their review. The study types will be those where standard PK analysis conducted, Population PK, and PBPK. Providing Regulatory Submissions in Electronic Format
FDA Non-binding documents and other resources can also be found in the FDA webpage for Study Data Standard Resources.
PMDA Non-Binding documents and other resources can also be found on the PMDA website for Advanced Review with Electronic Data Promotion Group. |
How do I make a test submission to the FDA?. | PHUSE Team Response: 7th June 2017 |
Will JumpStart (DataFit) services be available for Pharma clients before submission? What kind of checks are included in JumpStart?. | PHUSE Team Response: 7th June 2017 JumpStart as a Service is specific to FDA. There are multiple versions of open source validator tools available for use that are similar to the version of DataFit that FDA use. Use of a validator to check for compliance issues and inclusion of a Study Data Reviewer’s Guide will get a Sponsor close to all the information FDA looks at during the data fitness portion of a JumpStart service. The standard demographics analysis panels are available via the GitHub code repository. FDA will be sharing more scripts in the near future. Additional References: https://github.com/phuse-org/phuse-scripts |
When will CDISC (SDTM/ADaM) data standards be mandatory for data submission and how does this differ from for each regulatory agency?. | PHUSE Team Response: 12th September 2017
FDA Submission Type & Timing NDA, ANDA, and certain BLA submissions - Studies which start after 2016-12-17 (December 17th, 2016). Commercial INDs and amendments, except for submissions described in section 561 of the Federal Food, Drug, and Cosmetic Act - Studies which start after 2017-12-17 (December 17th, 2017). For the definition of "study start date," see the Providing Regulatory Submissions in Electronic Format - Standardized Study Data (PDF - 131 KB). Source for FDA: Japan (PMDA): Electronic data submission starts from 01-Oct-2016 with the transition period as noted below. PMDA Submission Type & Timing NDAs (eStudy Data submission criteria*) - Transition Period - Submission on or after 2016-10-01 (October 1st 2016) until 2020-03-31 (March 31st, 2020). All NDAs (eStudy Data submission criteria*) - Submission on or after 2020-04-01 (April 1st, 2020). During the transition period, PMDA accepts the legacy submission and partial data submission (hybrid submissions).
All required study data need to be submitted in CDISC format after April 1st, 2020.
*eStudy Data submission criteria: electronic data in CDISC format needed for studies meeting the following criteria.
Supported standard and versions data standard catalog and validation rules including rejection criteria are available together with applicable guidance on the PMDA Advance Review with Electronic Data promotion group website. Advice to European Medicines on Clinical trial data formats. (30APR2013)
China Food and Drug Administration (CDFA) has endorsed CDISC standards in their Clinical Trial Data Management Technology Guide* (July 2016): they mention "CDISC standards have seen more and more recognised and widely used in the industry, has become an international clinical trial data "common language". |
Manage space
Manage content
Integrations