Clinical Trial Operations Flashcards

What is 'enrollment rate monitoring' in clinical trial operations?

Answer: Tracking the rate at which subjects are enrolled against planned targets to identify and address recruitment issues

Enrollment rate monitoring compares actual subject enrollment to planned timelines, enabling sponsors to identify underperforming sites and implement corrective actions to meet recruitment goals.

What is a 'protocol waiver' in clinical trial operations?

Answer: A pre-approved, prospective exception allowing a specific deviation from protocol requirements for an individual subject

A protocol waiver is a prospective, sponsor-approved exception authorizing a specific protocol deviation for an individual subject before it occurs, documented to maintain GCP compliance.

What is the purpose of 'risk-based monitoring' (RBM) in modern clinical trials?

Answer: To focus monitoring activities on the highest-risk sites and data points rather than applying uniform 100% SDV to all sites

RBM uses risk assessment to direct monitoring resources where they are most needed, combining central statistical monitoring with targeted on-site visits rather than uniform 100% SDV.

What is 'investigator brochure' (IB) in clinical trial operations?

Answer: A document provided to investigators summarizing all preclinical and clinical data on the investigational product relevant to its study in humans

The IB is a comprehensive compilation of available preclinical and clinical information about the investigational product that informs investigators about risks, doses, and monitoring needs during the trial.

What is a 'subject withdrawal' vs. a 'subject lost to follow-up' in clinical trial operations?

Answer: Withdrawal is a subject's voluntary decision to discontinue; lost to follow-up means the site cannot locate or contact the subject

A withdrawal is an active, documented decision by the subject or investigator to discontinue participation, while lost to follow-up means the site has lost all contact despite reasonable attempts to reach the subject.

What is a 'deviation log' used for in clinical trial site management?

Answer: To document all protocol deviations at a site, including the description, impact assessment, and corrective actions taken

A deviation log provides a site-level record of all protocol deviations, including when they occurred, their potential impact on subject safety or data integrity, and corrective or preventive actions.