CCRC - Certified Clinical Research Coordinator IRB Roles and Responsibilities Questions and Answers

Question 1

A clinical research study that was initially approved by a full IRB committee is approaching its one-year approval anniversary.
What is the primary purpose of the IRB's continuing review for this ongoing study?

Accepted Answer

To reassess the risk-benefit ratio and ensure the continued protection of the rights and welfare of research participants.

Answer

To verify the accuracy of the data collected and ensure it aligns with the study's primary objectives.

Answer

To provide a formal summary of enrollment statistics to the study sponsor and regulatory authorities.

Answer

To renegotiate the site's budget based on the complexity and number of participants enrolled.

Question 2

A PI submits a protocol for a new minimal-risk study that will involve a one-time blood draw and a quality-of-life survey for healthy adults. This type of research typically does not require review at a convened IRB meeting. This level of review is known as:

Accepted Answer

Expedited Review

Answer

Exempt Determination

Answer

Full Board Review

Answer

Delayed Review

Question 3

During the conduct of a trial, the Principal Investigator realizes that a participant's screening lab tests were inadvertently performed one day before the informed consent form was signed and dated. How should the CRC expect this event to be handled with respect to the IRB?

Accepted Answer

The event must be reported to the IRB as a protocol deviation, as study procedures were conducted prior to obtaining consent.

Answer

The event should be documented in the site's internal files but does not need to be reported to the IRB as long as the participant was ultimately eligible.

Answer

The PI should inform the sponsor but wait for sponsor direction before taking any action with the IRB.

Answer

The participant should be asked to re-consent and back-date the form to the day before the lab draw to correct the error.

Question 4

Which of the following is a mandatory membership requirement for an Institutional Review Board (IRB) as specified by federal regulations (45 CFR 46)?

Accepted Answer

The IRB must have at least one member who is not affiliated with the institution.

Answer

The IRB must include at least two members with doctoral degrees in a biomedical science.

Answer

All members of the IRB must be employees of the institution to ensure accountability.

Answer

The IRB chairperson must be a physician with clinical research experience.

Question 5

The sponsor of a global oncology trial issues a protocol amendment. The only change is the addition of a new, non-investigational laboratory test to be drawn at the Week 8 visit to monitor for a rare but known side effect. What must the CRC confirm before implementing this change for any participants?

Accepted Answer

That the protocol amendment and any revised consent forms have been submitted to and approved by the IRB.

Answer

That the sponsor has notified the FDA of the change.

Answer

That the site's lab is certified to perform the new test.

Answer

That the Principal Investigator has personally signed off on the scientific merit of the change.

Question 6

What is the primary and overarching responsibility of an Institutional Review Board (IRB)?

Accepted Answer

To protect the rights and welfare of human subjects participating in research.

Answer

To ensure the scientific integrity and statistical power of the research design.

Answer

To protect the institution from legal and financial liability arising from research activities.

Answer

To facilitate the efficient and timely completion of clinical trials.

A clinical research study that was initially approved by a full IRB committee is approaching its one-year approval anniversary.What is the primary purpose of the IRB's continuing review for this ongoing study?

A clinical research study that was initially approved by a full IRB committee is approaching its one-year approval anniversary.
What is the primary purpose of the IRB's continuing review for this ongoing study?