Documentation Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Documentation flashcards as text
When must a protocol deviation be documented and reported to the IRB/IEC?
Answer: Promptly, in accordance with the IRB/IEC's reporting requirements
Protocol deviations must be documented and reported to the IRB/IEC promptly according to their specific reporting requirements. Many IRBs require reporting within a defined timeframe, especially for deviations that may affect subject safety or data integrity.
What is the correct procedure for correcting an error in source documentation?
Answer: Draw a single line through the error, write the correction, initial, and date it
The proper method for correcting source documents is to draw a single line through the error so the original entry remains legible, write the correct entry, and add initials and date of the person making the correction.
Which document formally authorizes the investigator to conduct the clinical trial at a specific site?
Answer: The regulatory authority approval letter or clinical trial authorization
The regulatory authority approval letter (or clinical trial authorization/IND approval) is the formal document that authorizes the investigator and site to conduct the clinical trial within that jurisdiction.
What information must be included in the site's regulatory binder for each clinical trial?
Answer: All essential documents listed in ICH-GCP Section 8
The regulatory binder must contain all essential documents as listed in ICH-GCP Section 8, including but not limited to the signed protocol, IRB/IEC approvals, CVs, financial disclosures, delegation logs, lab certifications, and correspondence.
What is the purpose of a certificate of analysis (CoA) for the investigational product?
Answer: To certify that the product batch meets predetermined quality specifications
A Certificate of Analysis certifies that a specific batch of investigational product has been tested and meets all predetermined quality specifications, including identity, purity, potency, and other quality attributes.
How should amendments to an approved protocol be handled according to GCP?
Answer: Submitted to the IRB/IEC for review and approval before implementation, except for safety changes
Protocol amendments must be submitted to and approved by the IRB/IEC before implementation. The only exception is when an amendment is necessary to eliminate an immediate hazard to trial subjects, in which case it may be implemented before approval but must be submitted promptly thereafter.