Search clear explanations of essential clinical research terms, expand definitions, and discover why each concept matters in practice.
Any unfavorable medical occurrence in a participant who has received an investigational product, whether or not it is considered related to that product.
Why it matters: Timely identification, documentation, assessment, and reporting protect participants and preserve reliable safety data.
A paper or electronic tool designed to capture protocol-required information for each study participant.
Why it matters: Accurate CRF completion depends on complete source records and clear resolution of inconsistencies.
A record showing which qualified study team members are authorized by the investigator to perform specific trial duties.
Why it matters: It connects responsibility, qualification, training, and actual study conduct.
Documents that individually and collectively permit evaluation of trial conduct and the quality of the data produced.
Why it matters: Complete, current, and traceable files demonstrate oversight and compliance.
An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human participants.
Why it matters: GCP protects participant rights and supports credible trial results.
An ongoing process through which a participant receives understandable information, has the opportunity to ask questions, and voluntarily agrees to participate.
Why it matters: A signed form alone does not prove that meaningful consent occurred.
A structured review conducted to assess participant protection, protocol compliance, data quality, and site performance.
Why it matters: Productive monitoring combines verification, risk awareness, clear communication, and practical follow-through.
A departure from the approved protocol or related study requirements.
Why it matters: Deviations require accurate assessment, documentation, reporting where applicable, and prevention planning.
Original records and certified copies containing clinical findings, observations, or other activities necessary to reconstruct and evaluate a trial.
Why it matters: Clear source records make the participant journey and study decisions understandable to someone who was not present.
