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ICH GCP Essential Document Checklist Welcome to URMC Urmc Rochester Form

ICH GCP Essential Document Checklist Welcome to URMC Urmc Rochester Form

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clinical researchers quick short video on what essential documents are when it comes to a research clinic and its participation in any study and it can be broken down into three different categories before the study begins during the study and after the study and it's literally all the regulatory documents pre-study start up which is all the start up documents 1572 financial disclosure form IRB approval protocol approval the protocol itself investigator brochure during the study you get into things like training logs delegation of authorities logs continuing IRB approvals and then closeout you have all the documents again right these are still essential documents but now you have the IRB closeout report and you have the archiving policy of the site also don't forget in the state startup it's the contracts but CRA is typically don't deal with study contracts so those are essential documents

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