Clinical Research and GCP Update

Individual Site Closures used to be required to be notified (A81.9) but Version 3 changed to NSM. Feb21

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Non ‐ Substantial Modification (NSM) which are NOT A81.9 NSMs. 3.3 V3

Non ‐ substantial modification NSM, i.e. without substantial impact on safety or rights of subjects and/or reliability and robustness of data and when information is not necessary for oversight) should not be notified as such . • No legal basis in the CTR to submit changes other than SM or A81.9. • No functionality developed in CTIS to support changes to trial data/documents other than via an SM or Art 81.9 • These changes should be implemented during the next substantial modification SM. • NSMs can be introduced in the trial documentation irrespective of the scope of the SM application, but they need to be listed and identified as NSMs in the cover letter • NSMs will have to be recorded in the Trial Master File

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© Brookwood Global (Canary Ltd) 2021

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