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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 | 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. 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)BIMO: Requirements for Clinical Site Data and Subject Level Data Listings for FDA CDER's Inspection Process |
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 White Paper 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 White Paper 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 White Paper |
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 Link to new page |
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 According to the FDA Study Data Technical Conformance Guide (version 4.0), Section 7, which describes the Electronic Submission Format, the misc folder should “contain datasets that do not qualify as analysis, profile, or tabulation datasets in this subfolder.” These datasets should be in SAS Transport Format (.xpt). Since these datasets do not qualify as analysis, profile, or tabulation they do not need to be included in the define.xml however information about use of these datasets should be included in the reviewer’s guide. If you have other documents/files that support the creation of your datasets, be they analysis or tabulation, or your TLGs, such as a spreadsheet for CTC Toxicity Grade or SMQ assignment, you can convert it to an acceptable format (e.g. PDF, TXT, or XPT) and place these in the “misc” folder. The file name must be in all lowercase letters or numbers with no spaces or special characters, only a hyphen is allowed in the name. Conventions on the files names can be found in the FDA document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Appendix 2, Name, page 11-12. Information about these additional files and their use in creating the datasets should be included in the reviewer’s guides Additional References: https://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163556.pdf |
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
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 FDA provides a dedicated website page on how to Submit an eCTD or Standardized Data Sample to the FDA – see reference below. The pages provides recommendations and steps to submit a sample submission Additional References: Submit an eCTD or Standardized Data Sample to the FDA.: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm174459.htm |
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 google code repository held by the PhUSE Standard Scripts working group. 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 Guidance for Industry, Providing Regulatory Submissions in Electronic Format - Standardized Study Data (PDF - 131 KB) 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)
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