Trial Documentation Flashcards

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

Answer: Sponsor-CRO Agreement

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

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

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.

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

Answer: Principal Investigator

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

A data clarification form (DCF) is issued when:

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.

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

Answer: Monitoring Visit Report

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

When must an investigator notify the sponsor of a protocol deviation?

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.

Which document provides the rationale for the investigational product dose, formulation, and route of administration?

Answer: Investigator Brochure

The Investigator Brochure compiles preclinical and clinical data to support the proposed dosing and administration regimen.