Good Clinical Practice & ICH Guidelines Flashcards

A GCP audit of a lactation study site differs from a routine monitoring visit in that an audit is:

Answer: A systematic, independent examination of trial activities to assess whether the trial was conducted per GCP and regulations

GCP audits are independent, systematic examinations separate from routine monitoring — they assess compliance with GCP, protocol, and applicable regulations.

Under GCP, a subject's right to withdraw from a lactation study at any time without penalty must be:

Answer: Honored immediately and without penalty or loss of benefits to which the subject is otherwise entitled

GCP mandates that withdrawal rights be unconditional — subjects may leave at any time without penalty, and this must be stated clearly in the consent form.

ICH E6 requires that an investigator maintain adequate delegation logs to document:

Answer: Which study tasks have been assigned to which qualified staff members

Delegation logs document which specific study tasks have been assigned to specific qualified personnel, ensuring accountability and GCP compliance.

In the context of ICH GCP, the term 'randomization' in a lactation intervention study refers to:

Answer: The process of assigning participants to treatment groups by chance to minimize bias

Randomization is the chance-based assignment of participants to treatment arms, a key GCP design feature that minimizes selection bias.

A sponsor conducting a GCP-compliant lactation study must ensure that an independent ethics committee (IEC) or IRB reviews and approves all EXCEPT which of the following?

Answer: The sponsor's internal audit report findings

Internal sponsor audit reports are confidential internal documents and are not submitted to or reviewed by the IRB/IEC under standard GCP requirements.

Under GCP, 'direct access' granted to monitors, auditors, and regulatory inspectors in a lactation study means:

Answer: Permission to examine, analyze, verify, and reproduce all records and reports relevant to the trial

GCP 'direct access' means unimpeded permission to examine, analyze, verify, and reproduce any records pertinent to evaluating the conduct and data quality of the trial.

ICH E6 GCP guidance on electronic data capture (EDC) systems in clinical studies requires that such systems:

Answer: Include audit trails, access controls, and validation to ensure data reliability and integrity

GCP requires that EDC systems be validated and include audit trails and access controls to ensure data reliability, traceability, and integrity.