ICH-GCP Compliance Flashcards

Under ICH E6(R2), which of the following best describes a 'Serious Adverse Event' (SAE)?

Answer: Any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, results in disability, or is a congenital anomaly

ICH E6(R2) defines an SAE as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability, or is a congenital anomaly/birth defect.

What does ICH-GCP require regarding direct access to source data/documents for regulatory authorities and sponsors?

Answer: The investigator and institution must allow direct access for monitoring, audits, and inspections

ICH E6(R2) Section 4.1.3 requires that the investigator/institution permit direct access to source data and documents for trial-related monitoring, audits, IEC/IRB review, and regulatory inspections.

According to ICH-GCP, what action is required when there is a change to an approved protocol?

Answer: A protocol amendment must be prepared, submitted, and approved by the IRB/IEC before implementation

ICH E6(R2) Section 4.5 requires that amendments to the protocol be documented as protocol amendments and approved by the IRB/IEC prior to implementation, except when immediate action is needed to protect subjects.

In ICH-GCP terminology, what is a 'Legally Acceptable Representative' (LAR)?

Answer: An individual or juridical body authorized by applicable law to consent on behalf of a prospective subject

ICH E6(R2) defines a LAR as an individual or juridical body authorized under applicable law to provide informed consent on behalf of a prospective subject who cannot consent for themselves.

What does ICH E6(R2) specify about the investigator's financial interests in a clinical trial?

Answer: Financial arrangements between the sponsor and investigator should be documented and any conflict of interest disclosed to the IRB/IEC

ICH E6(R2) requires that financial arrangements and any potential conflicts of interest between sponsors and investigators be documented and disclosed to the IRB/IEC as required.

Under ICH-GCP, what is the role of the 'Coordinating Investigator' in a multi-site clinical trial?

Answer: To take responsibility for coordinating investigators at different participating sites

ICH E6(R2) defines the Coordinating Investigator as an investigator assigned responsibility for the coordination of investigators at different centers participating in a multi-center trial.

Which of the following scenarios best illustrates a violation of ICH-GCP informed consent requirements?

Answer: A subject is enrolled before signing the consent form because the investigator believes delay could affect their health

Enrolling a subject before obtaining informed consent is a fundamental GCP violation; the only exception is a documented emergency where the subject cannot consent and no LAR is available.