Demo Questions

A sponsor may transfer trial-related activities to a CRO or other service provider, but the sponsor retains ultimate responsibility for those sponsor activities. Outsourcing does not transfer accountability for participant protection or data reliability. Exams often test the difference between delegated work and retained sponsor responsibility.

The FDA guidance explains that the IRB should review the protocol, the consent documents, and the methods and materials proposed to recruit subjects. For studies under an IND, the investigator’s brochure is also among the materials reviewed. That makes this option the best match because it includes the protocol, consent forms, recruiting scripts, and investigator’s brochure. The other choices add items that are not the core required set for this question, such as debriefing forms, research monitoring plans, conflict of interest information, or enrollment bonuses.

When significant noncompliance persists despite remediation, the sponsor should take proportionate action and may need to terminate the site’s participation. Persistent enrollment of ineligible participants can affect both participant safety and data integrity. Serious noncompliance may also require notification under applicable requirements.

The sponsor and investigator or institution should maintain a record of where essential records are located so they can be identified, retrieved, and reviewed when needed. Splitting records across systems is not automatically wrong, but uncontrolled storage creates risk. Traceability and retrievability are key close-out and inspection concepts.

Delegation records are still important, but ICH E6(R3) allows a proportionate approach. When activities are part of routine clinical practice, formal delegation documentation may not need the same level of detail as highly specialized trial tasks. The investigator remains responsible for oversight and should ensure roles are clear and appropriate to the activity.

Site staff should be appropriately trained for their delegated roles before trial activities begin. Activating a site without adequate training increases the risk of consent errors, eligibility mistakes, and poor documentation. Competitive enrollment pressure does not justify bypassing readiness requirements.

Computerized systems used for trial purposes should be validated as fit for purpose. The scale of validation can be proportionate to the system’s complexity, intended use, and the importance of the data, but small size does not remove the requirement. Documentation should show the system is reliable for its trial role.

All of the listed items are basic informed consent elements. A consent form should explain that the activity is research, state its purpose, describe experimental procedures, and give the expected duration of participation. Since each individual statement is part of the required basic content, the combined answer is correct.

The investigator should have timely access to protocol-collected data needed to make decisions about eligibility, treatment, ongoing participation, and participant safety. Waiting for data cleaning is not appropriate when safety-related decisions may be affected. The sponsor should ensure the flow of clinically relevant data supports safe trial conduct.

The participant or legally acceptable representative should have enough time and opportunity to review the information, ask questions, and decide whether to participate. A rushed signature does not meet the ethical and regulatory standard for informed consent. The process must support real understanding and voluntary choice unless there is a justified emergency situation.

Transferred sponsor activities should be described in a documented agreement so responsibilities are clear. A vendor’s reputation or certification does not replace the need for defined roles and responsibilities. This supports oversight, accountability, and inspection readiness.

Potential safety issues should be assessed promptly, not delayed until a routine monitoring visit. The investigator should review the event, determine the appropriate medical response, and ensure required reporting happens within protocol and regulatory timelines. Participant safety takes priority over administrative convenience.

The investigator or institution must retain essential records for the required retention period under applicable requirements or until informed they are no longer needed. The sponsor’s trial master file does not replace the site’s own responsibility to retain site records. Exams often test this separation of sponsor and investigator obligations.

The correct answer is that the consent should include the need for contraception. When a study presents possible reproductive risk, subjects should be informed of precautions needed to reduce that risk. The other options are either incomplete, overly specific, or inaccurate. The source material identifies the contraception requirement as the best answer.

The FDA guidance specifically says communications intended to be seen or heard by health professionals, including dear doctor letters and doctor-to-doctor letters, are not considered direct subject advertising that requires IRB review. In contrast, brochures in a clinic waiting room, flyers posted in the institution, and emails sent to potential community participants are directed toward prospective subjects or the public and generally do require IRB review.

Any premature unblinding, including accidental unblinding, should be documented and explained promptly to the sponsor. Even if the participant was not harmed, unblinding can affect trial integrity and may require additional action. Proper documentation protects both the participant and the study’s credibility.

The correct answer is all of the above because informed consent must address risks and benefits, alternative procedures when appropriate, confidentiality of records, contact information for questions about rights or injuries, and any compensation or treatment information for injury when applicable. Since each option reflects a recognized consent element, the combined answer is the best choice.

The investigator should document all protocol deviations, even when they may appear minor. Important deviations should also be explained. The site should not decide that undocumented deviations are acceptable simply because participant harm was not obvious.

Essential records should be collected and filed in a timely manner rather than left loose until an audit or close-out. Delayed filing increases the chance of loss, inconsistency, and poor oversight. Good documentation practice means maintaining records in a controlled and current state throughout the trial.

Final accountability of investigational product should be confirmed during close-out activities. Unresolved discrepancies should not be casually deferred because drug accountability is a core control for participant safety and data reliability. The close-out process should confirm the final disposition, return, or destruction status as applicable.

The investigator should be qualified by education, training, and experience, and the site should have adequate staff, facilities, and resources to conduct the trial properly. Trial experience matters, but it is not the only deciding factor. Exams often test whether candidates can distinguish true site suitability from prestige or publication history.

The FDA guidance states that certain communications are not considered direct advertising for subject recruitment that requires IRB review. These include communications intended to be seen or heard by health professionals, news stories, and publicity intended for other audiences such as financial page advertisements for investors. Since each listed item falls into that exempt group, the best answer is all of the above.

Close-out should confirm that essential trial tasks are adequately completed, including resolution of important outstanding issues. Archiving records before necessary close-out activities are addressed can make retrieval and correction more difficult. Records should remain accessible until close-out expectations are met and then be retained in a controlled archive.

ICH E6(R3) allows the informed consent discussion to be conducted by the investigator or other appropriately delegated site staff, if this is permitted by local requirements. The PI remains responsible for oversight of the process. The key point is that consent is a process requiring qualified, delegated personnel, not necessarily the PI alone.

The FDA guidance says an internet listing for a clinical trial does not need IRB review when it is limited to basic descriptive information. This includes the study title, a brief protocol summary or purpose, basic eligibility criteria, the study location, and contact information. If the listing goes beyond that and emphasizes benefits, payment incentives, or extra free services, it may require IRB review because it could influence participation in a way that should be evaluated.