Which document lists all subjects enrolled and is kept confidential for potential follow-up?

Prepare for the ICH Good Clinical Practice (GCP) Exam for Certified Clinical Research Coordinator with engaging multiple-choice questions and detailed explanations. Elevate your understanding and expertise to excel in your certification exam!

Multiple Choice

Which document lists all subjects enrolled and is kept confidential for potential follow-up?

Explanation:
The document that lists every enrolled subject with their coded study identifiers while keeping real identities confidential is the Completed Subject Identification Code List. This list links each participant’s code to their actual identity in a secure, restricted-access file, enabling legitimate follow-up (for safety checks, data verification, or regulatory inquiries) without exposing personal information in the study data. It is kept separate from the main datasets and reports to protect confidentiality. Other documents serve different purposes—final investigator reports summarize results, records of retained body fluids pertain to specimens, and audit certificates document compliance—so they do not function as the confidential linkage key for follow-up.

The document that lists every enrolled subject with their coded study identifiers while keeping real identities confidential is the Completed Subject Identification Code List. This list links each participant’s code to their actual identity in a secure, restricted-access file, enabling legitimate follow-up (for safety checks, data verification, or regulatory inquiries) without exposing personal information in the study data. It is kept separate from the main datasets and reports to protect confidentiality. Other documents serve different purposes—final investigator reports summarize results, records of retained body fluids pertain to specimens, and audit certificates document compliance—so they do not function as the confidential linkage key for follow-up.

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