SOCRA ICH Good Clinical Practice 3 — Questions and Answers
Question 1: According to ICH E6, which of the following is a key qualification requirement for a clinical trial investigator?
- Must hold a medical degree regardless of the trial type
- Must be adequately trained and experienced to conduct the trial (Correct answer)
- Must have at least 5 years of prior GCP research experience
- Must be employed full-time at the investigational site
Correct answer: Must be adequately trained and experienced to conduct the trial
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:
- Each delegate holds a medical license
- All staff are aware that the investigator alone takes responsibility
- Each delegate is qualified and adequately trained for the assigned tasks (Correct answer)
- Delegation is limited to licensed healthcare professionals only
Correct answer: Each delegate is qualified and adequately trained for the assigned tasks
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:
- Obtain IEC approval before deviating from the protocol
- Document and explain the deviation and notify the sponsor and IEC promptly (Correct answer)
- Withdraw the subject from the trial immediately
- Continue the deviation without reporting if the subject is not harmed
Correct answer: Document and explain the deviation and notify the sponsor and IEC promptly
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:
- Satisfy regulatory filing requirements for the site
- Provide clinical and nonclinical data to support the safe use of the investigational product (Correct answer)
- Serve as the protocol for the trial
- Document the investigator's product training
Correct answer: Provide clinical and nonclinical data to support the safe use of the investigational product
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?
- Accountability may be delegated to the pharmacy without any investigator oversight
- The investigator must maintain records of product receipt, use, return, and destruction (Correct answer)
- Product accountability records are kept exclusively by the sponsor's CRO
- Only unused product needs to be accounted for at the end of the trial
Correct answer: The investigator must maintain records of product receipt, use, return, and destruction
ICH E6 section 4.6 requires the investigator to maintain accurate records of the investigational product at the site throughout the trial.
Question 6: Under ICH GCP, when is an investigator permitted to break the blind in a double-blind trial?
- Whenever the monitor requests it during a routine visit
- Only when it is medically necessary to protect the subject's safety (Correct answer)
- At any time if the investigator believes the subject is in the control arm
- Only after written IEC permission is obtained
Correct answer: Only when it is medically necessary to protect the subject's safety
ICH E6 allows unblinding only when medically necessary for subject safety, and the investigator must document and promptly report the unblinding.
Question 7: An investigator fails to report a serious adverse event to the sponsor within the ICH GCP-required timeframe. This is considered a:
- Minor protocol deviation that can be noted in the study close-out report
- Significant protocol deviation with potential regulatory and ethical consequences (Correct answer)
- Administrative error correctable by a sponsor waiver
- Non-issue if the event resolved without sequelae
Correct answer: Significant protocol deviation with potential regulatory and ethical consequences
Failure to report SAEs within the required timelines is a significant GCP deviation that can compromise subject safety and data integrity, with regulatory consequences.
SOCRA ICH Good Clinical Practice 3
According to ICH E6, which of the following is a key qualification requirement for a clinical trial investigator?