Interested in how "updated" as in "updated section 1 of the Protocol" is translated language to language. ...
Good afternoon, A sponsor is questioning patient data input from a report in 2012. The sponsor asked ...
Over the past 2 decades, the administrative burden for study site coordinator has significantly increased. ...
I think the sponsor should be able to supply their policy. Wouldn't the study protocol have included ...
The site already did the remote consenting (which was 21 CFR Part 11 compliant and compliant with the ...
I would think all parties would have to be okay with remote consenting. The IRB would definitely have ...