Clinical Research and GCP Update

Part II Document Harmonisation Guidance Version 3. Nov 2020

• Aim of providing a set of harmonised documents for sponsors is to facilitate the application process. • However – “Member States may have national expectations and requirements…” ! • CTR 2 types of “Investigators” (A2.15 & 16):- 1. an investigator working by him/her self; 2. PI “leader of a team of investigators”. • EMA has decided that only the CV of the PI needs to be submitted … unless .. individual MS require different!

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Investigator Curriculum Vitae. Version 3.4. June 2019

• Very different layout to TransCellerate Biopharma CV template, but broadly has similar content. TransCellerate has more on personal information. • CV does include GCP training • EMA – “National requirements regarding the signature on the CV (electronic, wet, none) vary, sponsors should follow the national requirements”. • EMA has decided that only the CV of the PI needs to be submitted … unless .. individual MS require different!

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