SCDM Clinical Trial Operations 1

Question 1

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

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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.

SCDM - Society for Clinical Data Management Practice Test

SCDM - Society for Clinical Data Management Practice Test

SCDM Clinical Trial Operations 1