Clinical Research and GCP Update

Changes to Reporting Non Substantial Modifications (NSM) (Q&A 3.3 & 3. 4) & Annex III (A 81.9) • “Non-Substantial changes relevant to the supervision of the trial (Art 81.9) are a new concept under the CTR”, … Some NSMs you may have Expected to report e.g. :-̶ Change of the existing sponsor’s name, but same legal entity̶ Change in the sponsor/co-sponsor contact details Some NSMs reporting that you might NOT have expected e.g.:-̶ Annual IB update without safety, efficacy or benefit/risk update ̶ Change of contact details of principal investigator (email address, phone number) when timely provision of this information is necessary for adequate supervision of the trial • When to submit:- “Sponsors can always provide non-substantial changes as part of an application for a substantial modification (part I only, part II only or part I and part II) whenever the scope of the non-substantial changes matches with the scope of the application under evaluation”

133

134

© Brookwood Global (Canary Ltd) 2021

67