Clinical Trial Operations Flashcards

What is a 'randomization scheme' in a clinical trial?

Answer: A pre-planned method for randomly assigning subjects to treatment groups to minimize bias

A randomization scheme defines the method (e.g., simple, stratified, block) for randomly assigning subjects to treatment arms, ensuring comparability between groups and reducing selection bias.

What is 'stratified randomization' in clinical trials?

Answer: Randomization within subgroups defined by key prognostic factors to ensure balanced treatment arms within each stratum

Stratified randomization first divides subjects into subgroups (strata) based on prognostic factors like age or disease severity, then randomizes within each stratum to ensure balance across key variables.

What is the purpose of a 'screening log' in clinical trial operations?

Answer: To record all subjects who were screened for eligibility, including those who failed screening and the reasons why

A screening log documents every subject screened for eligibility, including screen failures with reasons, providing a complete accounting of the screening process for regulatory review.

What is a 'site initiation visit' (SIV) in clinical trial operations?

Answer: A visit conducted by the sponsor before a site begins enrolling subjects to verify readiness and train site staff

An SIV is conducted by the sponsor or CRO before enrollment begins to confirm the site is qualified, staff are trained, and all materials and systems are in place for compliant trial conduct.

What is 'investigational product accountability' in clinical trial operations?

Answer: The tracking, documentation, and reconciliation of all investigational product received, dispensed, returned, and destroyed at each site

IP accountability involves maintaining complete records of IP receipt, storage, dispensing, returns, and destruction at each site to verify that IP was used only as specified by the protocol.

What is the role of an 'independent ethics committee' (IEC) in clinical trial operations?

Answer: To review and approve trial protocols, amendments, and consent forms to protect the rights and welfare of research subjects

An IEC (equivalent to an IRB in the US) reviews and approves study protocols, amendments, and informed consent forms before a trial begins to ensure ethical conduct and subject protection.