CTA Trial Documentation 2

Question 1

Which document defines the responsibilities and procedures for transferring sponsor obligations to a Contract Research Organization (CRO)?

Accepted Answer

Sponsor-CRO Agreement

Answer

A Sponsor-CRO Agreement formally documents the transfer of specific sponsor duties and liabilities to the CRO.

Question 2

What is the purpose of a Source Data Verification (SDV) log maintained during a clinical trial?

Accepted Answer

To document that CRF data matches original source records

Answer

SDV logs provide a traceable record that data transcribed into CRFs accurately reflects the source documents.

Question 3

Under ICH E6(R2), which party is responsible for ensuring that essential documents are retained at the investigator site?

Accepted Answer

Principal Investigator

Answer

The principal investigator is responsible for retaining trial-related essential documents at the site for the required period.

Question 4

A data clarification form (DCF) is issued when:

Accepted Answer

A discrepancy is found between CRF data and source documents

Answer

DCFs are used by monitors or data management to request clarification or correction of inconsistent or missing CRF entries.

Question 5

Which essential document records the date, duration, findings, and follow-up actions from a monitoring visit?

Accepted Answer

Monitoring Visit Report

Answer

A monitoring visit report documents all activities, observations, and action items from a specific site monitoring contact.

(CTA) Clinical Trial Associate Certification Practice Test