SCDM Clinical Trial Operations

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 schedule of protocol-defined site visits by the sponsor monitor

Answer

A plan for recruiting subjects from multiple geographic regions

Answer

A procedure for randomly selecting sites to receive a masked treatment

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

Randomization performed separately at each clinical site

Answer

A method of randomizing subjects based on their screening lab values

Answer

Sequential assignment of subjects to treatment groups by enrollment order

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

To document the schedule of monitoring visits at each site

Answer

To track all protocol deviations identified during the study

Answer

To record the dates when each site received investigational product

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

The first monitoring visit after a site enrolls its first subject

Answer

A visit by a regulatory inspector to verify GCP compliance

Answer

A site visit to install and validate the EDC system hardware

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

The process of verifying that all subjects received the correct dose of study drug

Answer

A financial audit of investigational product procurement costs

Answer

The documentation of investigational product storage temperature logs

Question 6

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

Accepted Answer

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

Answer

To conduct financial audits of sponsor payments to clinical sites

Answer

To monitor ongoing safety data and recommend protocol modifications

Answer

To verify GCP compliance during regulatory inspections