Protocol_Development flashcards

What is a trial protocol?

An essential document that provides a full description of the trial and all its procedures, outlining the rules, eligibility, and roles involved.

Why are clinical trial protocols important?

They ensure ethical and scientific quality in trial design and implementation, facilitate proper data collection and patient safety.

Who takes primary responsibility for the conduct of a trial?

The Chief Investigator.

What are essential documents in a clinical trial?

Documents that aid in evaluating trial conduct, participant safety, and data quality.

What should a good protocol include?

Clarity, operational feasibility, compliance with guidelines, and incorporation of expert opinion.

What are the risks of a poorly written protocol?

Delays in timelines, misinterpretation by staff, jeopardized patient safety, and compromised data integrity.

What approvals are needed before starting a clinical trial?

Approval from a regulatory body (e.g. MHRA) and ethical approval from a Research Ethics Committee (REC).

What distinguishes substantial amendments from non-substantial amendments in protocol changes?

Substantial amendments significantly impact scientific value or safety, while non-substantial amendments do not.

How should protocol deviations be managed?

They must be reported to the Sponsor to aid trial management and ensure adherence to the protocol.

What is the importance of publishing clinical trial protocols?

It promotes transparency and allows for appraisal of the trial's design and conduct by various stakeholders.

What are some key sections to include in a clinical trial protocol?

Introduction, trial design, aims and objectives, eligibility criteria, safety section, data management, and participant timeline.

What is the primary document that guides the conduct of a clinical trial?

The trial protocol.

What is ICH GCP?

International Council for Harmonisation Guideline for Good Clinical Practice, an international standard ensuring ethical and scientific quality in trials.

What is patient and public involvement (PPI) in trial protocols?

The involvement of patients and the public in the trial design and conduct process.

What is the purpose of a protocol review committee (PRC)?

To evaluate and provide feedback on the clinical trial protocol before approval.