SOCRA CCRP Documentation 3

Question 1

When must a protocol deviation be documented and reported to the IRB/IEC?

Accepted Answer

Promptly, in accordance with the IRB/IEC's reporting requirements

Answer

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.

Question 2

What is the correct procedure for correcting an error in source documentation?

Accepted Answer

Draw a single line through the error, write the correction, initial, and date it

Answer

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.

Question 3

Which document formally authorizes the investigator to conduct the clinical trial at a specific site?

Accepted Answer

The regulatory authority approval letter or clinical trial authorization

Answer

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.

Question 4

What information must be included in the site's regulatory binder for each clinical trial?

Accepted Answer

All essential documents listed in ICH-GCP Section 8

Answer

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.

Question 5

What is the purpose of a certificate of analysis (CoA) for the investigational product?

Accepted Answer

To certify that the product batch meets predetermined quality specifications

Answer

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.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Documentation 3