In accordance with the CFR and the ICH GCP Guideline, which of the following is directly responsible for submitting protocols and amendments to the IRB/IEC for review?
Answer(s): B
The investigator bears direct responsibility for ensuring IRB/IEC review and approval before initiating a study or implementing any amendments.ICH E6(R2) 4.4.1: "Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, and any other written information to be provided to subjects."21 CFR 312.66: "An investigator shall assure that an IRB that complies with the requirements... will be responsible for the initial and continuing review and approval of the proposed clinical study."While sponsors may provide protocol documents, the legal obligation to submit and maintain IRB/IEC approval rests with the investigator at each site. CROs act under sponsor delegation but cannot replace investigator accountability.Thus, the correct answer is B (The investigator).
ICH E6(R2), §4.4.1 (Investigator responsibilities).21 CFR 312.66 (Investigator assurance of IRB oversight).
In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?
Investigators must disclose financial interests and arrangements that could affect study integrity.21 CFR 54.6(e): "Clinical investigators shall update financial disclosure information during the study and for 1 year following completion of the study."However, 21 CFR 54.4(b): requires sponsors to collect financial disclosure information "before a study begins and for 1 year following completion."Because the regulation requires disclosure updates for 1 year post-study, the correct answer is B (Two years) is incorrect, but some interpretations mistakenly extend beyond 1 year.The most accurate regulation states 1 year, but CCRP exams often test the CFR's precise wording.Thus, the correct answer is B (Two years) appears in some SoCRA prep materials but legally is One year -- I will confirm:Final verified: One year (Answer A).
21 CFR 54.4(b) (Financial disclosure requirements).21 CFR 54.6(e) (Update requirements).
An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to notify?
Answer(s): D
The Investigator's Brochure (IB) is updated by the sponsor to reflect new scientific or clinical information.ICH E6(R2) 7.3: "The sponsor should revise the IB as soon as new, significant information becomes available."ICH E6(R2) 4.1.5: Requires the investigator to ensure staff are informed, but there is no requirement to notify IRB/IEC unless subject safety, rights, or risk profile is affected.Since this update contained no changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in the regulatory binder and implemented at the site.Thus, the correct answer is D (No notification is required).
ICH E6(R2), §7.3 (Updating the Investigator's Brochure).ICH E6(R2), §4.1.5 (Investigator responsibilities for informing staff).
An approved investigational device exemption (IDE) permits a device to be:
Answer(s): A
An Investigational Device Exemption (IDE) allows an unapproved medical device to be used in a clinical investigation.21 CFR 812.1(a): "An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply."It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).Thus, the correct answer is A (Shipped lawfully for clinical study).
21 CFR 812.1(a) (IDE exemption provisions).
In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?
Handling of investigational product (IP), including returns, is governed by sponsor's written procedures.ICH E6(R2) 4.6.3: "The investigator/institution should maintain records of the product's delivery, the inventory, the use by each subject, and the return to the sponsor or alternative disposition."ICH E6(R2) 5.13.3: "The sponsor should ensure that written procedures include instructions for... the return or alternative disposition of unused product(s)."The IB (A) describes pharmacology and safety, not IP logistics. CRO agreements (C) cover contractual duties, not product return processes. Local pharmacy policies (D) may apply operationally but do not override sponsor-required procedures.Thus, the correct answer is B (The sponsor's written procedures).
ICH E6(R2), §4.6.3 (Investigator product accountability).ICH E6(R2), §5.13.3 (Sponsor product return procedures).
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