Comment from CDISC Protocol Deviation Sub-Team
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Summary: The commenter is seeking clarification and alignment on specific technical variables and terminology within the draft guidance to ensure consistency with existing CDISC standards and other industry guidelines. They request that the FDA consider using the term "Non-Important" and clarify whether the new recommendation requires reporting all protocol deviations in the SDTM DV domain, noting the significant impact this would have on current sponsor processes.
In lines 248 to 250 it states that “a variable in the DV domain that provides the sponsor’s determination of whether the protocol deviation was important.”. Is it acceptable for a sponsor to use an existing SDTM variable e.g. DVCAT (Category for Protocol Deviation) or should a new variable specific to the purpose of "determination of whether the protocol deviation was important" be used e.g. DVCLASI (Classification of Protocol Deviation) as proposed in draft SDTMIG 4.0.
In lines 176 and 177 its states that the sponsor can choose the term to describe “All other protocol deviations that do not meet the definition of an important protocol deviation may encompass the commonly used terms minor, noncritical, and non-significant deviations.”.
Is it possible for the FDA PD guidance to be updated to align the FDA BIMO TCG 3.1 Appendix 3 Table B where the variable 28 NOIMPDEV (Number of Non-Important Protocol Deviations) uses the term Non-Important?
This also aligns with the TransCelerate Protocol Deviations Guidance (2020-08-10) section 3.2.
If it is not possible for the FDA to the single term of "Non-Important" is it possible to add "Non-Important" to the list of examples. Some organizations can read non-binding recommendations from the FDA as Normative and change their processes based on them.
In Line246 to 248 , it states that “Sponsors should also report all protocol deviations in the Study Data Tabulation Model Protocol Deviation (DV) domain, which will assist FDA in confirming whether protocol deviations had a significant impact on data quality.”. Does this new recommendation require all studies to include non-important PD in SDTM DV domain? In the FDA BIMO TCG 3.1 section I.A major (i.e., pivotal) studies are required. A number of sponsor organization in the CDISC Protocol Deviation Sub-Team do not currently report all PDs in the DV domain only those assessed as Important. This recommendation would have a large impact on these organizations.
Does the FDA also recommend to include Non-Important PDs in ADaM or is this a sponsor decision?
When the final PD Guidance is published by the FDA is it possible to update the FDA Study Data Technical Conformance Guide (sdTCG) section 4.1.1.3 DV Domain (Protocol Deviations) with the relevant updates for the DV domain or a reference the FDA PD Guidance.
Having the FDA PD Guidance in or referenced from the sdTCG will support sponsors in adhering to the guidance.