SOCRA ICH Good Clinical Practice 3

Question 1

According to ICH E6, which of the following is a key qualification requirement for a clinical trial investigator?

Accepted Answer

Must be adequately trained and experienced to conduct the trial

Answer

ICH E6 section 4.1 requires investigators to be qualified by education, training, and experience to assume responsibility for the trial.

Question 2

Under ICH GCP, an investigator who delegates trial tasks to study staff must ensure that:

Accepted Answer

Each delegate is qualified and adequately trained for the assigned tasks

Answer

ICH E6 section 4.2 requires investigators to ensure that any delegated individuals are qualified and trained for the specific tasks they perform.

Question 3

When a subject's condition requires a protocol deviation to avoid immediate harm, the investigator must:

Accepted Answer

Document and explain the deviation and notify the sponsor and IEC promptly

Answer

ICH E6 permits urgent deviations to protect subject safety but requires prompt documentation and notification to the sponsor and IEC.

Question 4

According to ICH E6, the investigator's brochure (IB) is provided to the investigator primarily to:

Accepted Answer

Provide clinical and nonclinical data to support the safe use of the investigational product

Answer

The IB compiles relevant clinical and nonclinical information to help investigators understand and manage risks associated with the investigational product.

Question 5

Which statement best describes an investigator's responsibility for investigational product accountability at the site?

Accepted Answer

The investigator must maintain records of product receipt, use, return, and destruction

Answer

ICH E6 section 4.6 requires the investigator to maintain accurate records of the investigational product at the site throughout the trial.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA ICH Good Clinical Practice 3