CRP Research Project Management & Coordination Flashcards

What is the purpose of a protocol deviation report?

Answer: To document and assess instances where protocol requirements were not followed

Protocol deviation reports document unplanned departures from the approved protocol and assess their impact on participant safety and data integrity.

What distinguishes a protocol 'deviation' from a protocol 'violation' in most research settings?

Answer: Violations involve unapproved changes that may affect safety or data integrity, while deviations are minor unplanned variances

Violations are generally more serious departures that may compromise participant safety or data validity, requiring prompt IRB and possibly sponsor reporting.

What is the purpose of a monitoring visit conducted by a sponsor's Clinical Research Associate (CRA)?

Answer: To verify data accuracy, protocol compliance, and participant safety at the site

Sponsor monitoring visits verify that data are accurate, complete, and consistent with source documents, and that the protocol and regulations are being followed.

In clinical trial management, what is 'randomization'?

Answer: Random assignment of participants to study groups to reduce bias

Randomization assigns participants to treatment or control groups by chance, minimizing selection bias and confounding.

What does the term 'blinding' (or 'masking') refer to in a clinical study?

Answer: Keeping participants and/or staff unaware of treatment assignments to prevent bias

Blinding keeps one or more parties unaware of treatment assignments, reducing the risk of bias in outcomes assessment.

What is a CONSORT diagram used for in research project management?

Answer: Reporting the flow of participants through each stage of a clinical trial

The CONSORT flow diagram transparently shows how participants moved from screening through completion or withdrawal, supporting reproducibility.