ACRP Certified Professional ACRP-CP Question # 8 Topic 1 Discussion
ACRP-CP Exam Topic 1 Question 8 Discussion:
Question #: 8
Topic #: 1
The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?
Before proceeding with any trial-related activities, including subject screening, the site must first obtain IRB/IEC approval. This approval ensures that the study has been reviewed for ethical considerations, risk assessment, and adherence to regulatory requirements. Without IRB/IEC approval, initiating the study would violate ethical guidelines and regulatory standards.
GCP guidelines mandate that no clinical trial procedures, including screening, commence without prior IRB/IEC approval.
"IRB/IEC approval must be obtained before initiating any study-related activities, including screening and subject recruitment."
Objectives:
Ensure ethical compliance before study initiation.
Protect participant rights and safety.
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