SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates ICH Good Clinical Practice 1

Question 1

According to ICH E6(R2), which of the following best describes the definition of 'Good Clinical Practice' (GCP)?

Accepted Answer

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects

Answer

ICH E6(R2) defines GCP as an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects, ensuring that the rights, safety, and well-being of subjects are protected and that clinical trial data are credible.

Question 2

Under ICH E6(R2), what is the primary purpose of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC)?

Accepted Answer

To safeguard the rights, safety, and well-being of all trial subjects by reviewing and providing ongoing oversight of the trial

Answer

Per ICH E6(R2), the IRB/IEC exists to safeguard the rights, safety, and well-being of human subjects involved in a trial. It reviews protocols, informed consent documents, and other relevant information, and provides continuing oversight throughout the trial.

Question 3

Which ICH E6(R2) section specifies that an investigator must be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial?

Accepted Answer

Section 4 — Investigator

Answer

ICH E6(R2) Section 4 outlines investigator responsibilities and qualifications, stating that the investigator must be qualified by education, training, and experience to conduct the trial properly, and must be thoroughly familiar with the investigational product and protocol.

Question 4

According to ICH E6(R2), what is the required timeframe for an investigator to report an unexpected serious adverse event (SAE) to the sponsor?

Accepted Answer

Within 24 hours of becoming aware of the event, followed by a written report within 8 days

Answer

ICH E6(R2) Section 4.11 requires that all serious adverse events be reported immediately to the sponsor, except those identified in the protocol as not requiring immediate reporting. The standard expectation is immediate (within 24 hours) notification with a detailed written follow-up within 8 days.

Question 5

Under ICH E6(R2), which of the following is considered an essential document that should be in the Trial Master File (TMF) before the clinical phase of the trial begins?

Accepted Answer

The signed investigator protocol agreement and CV of the principal investigator

Answer

ICH E6(R2) Section 8.2 lists essential documents that should be available before the clinical phase begins. These include the signed protocol agreement and the investigator's current CV, which demonstrate the investigator's qualifications and their formal commitment to the protocol.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates ICH Good Clinical Practice 1