Good day,


We have encountered an EDC vendor who states they do not provide e-copies of the Investigator CRFs at the end of the study to the investigator/site - this is a large, well-known EDC provider. The sponsor is completing a study in the UK and wants to ensure they are in compliance with ICH E6 R2 & MHRA requirements.

This EDC vendor states they only provide PDF copies of the e-CRFs to the investigators at study end. This seems strange to us and results in the sponsor not being in regulatory compliance by providing Investigators with these PDF copies of the eCRFs.

This seems strange to us for the following reasons:
1-certiifed copies definition by ICH E6 R2 is not met with a PDF copy
2-ICH E6 R2 8.1 states copies are to meet the requirements of certified copies
3-ICH E6 R2 8.13 & 8.14 state a copy is kept by the site (ie infers certified copies - yes?)
3-ICH E6 R2 8.4 does not address this topic

Question: Does the sponsor need to be sure that the Investigators/sites are provided with e-copies of CRF, ePRO and eCOA data -by their EDC vendor?

Thank you!