Investigator Brochure receipt

[Eileen]

I cannot find any reference for the need to keep evidence of the Investigator's signed receipt of an Investigator Brochure in the sponsor/CRO TMF. Although I feel that it is right to do so to prove that the Investigator actually received the Brochure (as opposed to a secretary signing the courier receipt) without any direct reference to a regulation I am having difficulty in convincing my peers. What are other's views on this?

[Vyara Stefanova]

Hi,
you can try to reffer the GCP point that investigator should be informed aboout any new information avaialble for the IMP, which is the update of the IB. The IB receipt is documentation of this sponsor responsibility. I would also reccomend that sub-investigator are also informed, which can be done by the CRA and documented in atraining log for example
Hope this helps