CTA Trial Documentation 2 — Questions and Answers
Question 1: Which document defines the responsibilities and procedures for transferring sponsor obligations to a Contract Research Organization (CRO)?
- Investigator Brochure
- Clinical Trial Agreement
- Sponsor-CRO Agreement (Correct answer)
- Site Initiation Visit Report
Correct answer: Sponsor-CRO Agreement
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?
- To record protocol amendments approved by the IRB
- To document that CRF data matches original source records (Correct answer)
- To track investigational product shipments
- To log adverse event narratives
Correct answer: To document that CRF data matches original source records
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?
- IRB/IEC
- Sponsor
- Regulatory authority
- Principal Investigator (Correct answer)
Correct answer: Principal Investigator
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:
- The protocol requires an amendment
- A discrepancy is found between CRF data and source documents (Correct answer)
- An SAE is reported to the sponsor
- A subject withdraws informed consent
Correct answer: A discrepancy is found between CRF data and source documents
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?
- Site Qualification Report
- Monitoring Visit Report (Correct answer)
- Protocol Deviation Log
- Investigator Brochure
Correct answer: Monitoring Visit Report
A monitoring visit report documents all activities, observations, and action items from a specific site monitoring contact.
Question 6: When must an investigator notify the sponsor of a protocol deviation?
- Only at study close-out
- Within the timeframe specified in the protocol or monitoring plan (Correct answer)
- Annually during audit preparation
- Only if the deviation affects a primary endpoint
Correct answer: Within the timeframe specified in the protocol or monitoring plan
Protocol and monitoring plan requirements dictate the notification timeline so sponsors can assess impact and take corrective action.
Question 7: Which document provides the rationale for the investigational product dose, formulation, and route of administration?
- Case Report Form
- Investigator Brochure (Correct answer)
- Site Master File
- Drug Accountability Log
Correct answer: Investigator Brochure
The Investigator Brochure compiles preclinical and clinical data to support the proposed dosing and administration regimen.
CTA Trial Documentation 2
Which document defines the responsibilities and procedures for transferring sponsor obligations to a Contract Research Organization (CRO)?