SCDM Clinical Trial Operations 1 — Questions and Answers
Question 1: What is a 'randomization scheme' in a clinical trial?
- A pre-planned method for randomly assigning subjects to treatment groups to minimize bias (Correct answer)
- A schedule of protocol-defined site visits by the sponsor monitor
- A plan for recruiting subjects from multiple geographic regions
- A procedure for randomly selecting sites to receive a masked treatment
Correct 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.
Question 2: What is 'stratified randomization' in clinical trials?
- Randomization within subgroups defined by key prognostic factors to ensure balanced treatment arms within each stratum (Correct answer)
- Randomization performed separately at each clinical site
- A method of randomizing subjects based on their screening lab values
- Sequential assignment of subjects to treatment groups by enrollment order
Correct 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.
Question 3: What is the purpose of a 'screening log' in clinical trial operations?
- To record all subjects who were screened for eligibility, including those who failed screening and the reasons why (Correct answer)
- To document the schedule of monitoring visits at each site
- To track all protocol deviations identified during the study
- To record the dates when each site received investigational product
Correct 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.
Question 4: What is a 'site initiation visit' (SIV) in clinical trial operations?
- A visit conducted by the sponsor before a site begins enrolling subjects to verify readiness and train site staff (Correct answer)
- The first monitoring visit after a site enrolls its first subject
- A visit by a regulatory inspector to verify GCP compliance
- A site visit to install and validate the EDC system hardware
Correct 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.
Question 5: What is 'investigational product accountability' in clinical trial operations?
- The tracking, documentation, and reconciliation of all investigational product received, dispensed, returned, and destroyed at each site (Correct answer)
- The process of verifying that all subjects received the correct dose of study drug
- A financial audit of investigational product procurement costs
- The documentation of investigational product storage temperature logs
Correct 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.
Question 6: What is the role of an 'independent ethics committee' (IEC) in clinical trial operations?
- To review and approve trial protocols, amendments, and consent forms to protect the rights and welfare of research subjects (Correct answer)
- To conduct financial audits of sponsor payments to clinical sites
- To monitor ongoing safety data and recommend protocol modifications
- To verify GCP compliance during regulatory inspections
Correct 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.
SCDM Clinical Trial Operations 1
What is a 'randomization scheme' in a clinical trial?