At which study visits can the site expect the sponsor to review subjects' signed informed consent forms?

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25-08-2017
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At which study visits can the site expect the sponsor to review subjects' signed informed consent forms?

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celai celai · Answer 1 · 2017-09-06T10:43:23+02:00

The answer is close out visit which

• Ensure regulatory documents on site match in house file
• Endure all CRF are complete and submitted to sponsor
• All queries are addressed
• AE/SAE follow up are addressed
• All signed informed consent forms are files
• Ensure study drug logs are complete and all study drug returned to sponsor per instructions
• Ensure investigator brochure and study materials are filed together
• Review long term storage and final report is completed and submitted to IRB and sponsor