Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?

After completion of a Phase III trial, which document should IRB/IEC retain?

A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?

On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. According to the CFR, what is the earliest date when the site may begin to destroy the study records?

A study will enroll 420 subjects over 3.5 years. What is expected average monthly accrual?

Which document was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and summarizes the basic ethical principles and guidelines for the conduct of research involving human subjects?

A subject was instructed to do a glucose check 4 times a day for 10 days using an investigational glucose meter. The meter requires one new glucose test strip for each test. The subject received the meter along with 45 glucose test strips. How many unused test strips should the subject have after the 10 days?

For a Significant Risk device study, an investigator must report within 5 working days which event?

An unconscious patient experiencing life-threatening cardiac arrhythmias has been admitted to an emergency room. No FDA-approved treatment is available, and no legal representative is present. The clinical investigator determined that the use of an investigational antiarrhythmic drug is required. In accordance with the CFR, who must certify the investigator's determination?

After the sponsor’s auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?

A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:

A research site was invited to participate in an investigational drug study. Which of the following parties is responsible for determining the risk-benefit ratio at the site?

During an IND study closeout, a monitor discovered remaining investigational product. Which procedures must be followed for disposition?

According to the ICH GCP Guidelines, what is the purpose of source documents?

When can the IRB/IEC require that additional information be given to subjects as part of informed consent?

A sponsor received a report from an investigator regarding the investigator's use of an investigational device without having obtained informed consent. The sponsor must submit a copy of the report to the FDA within:

In accordance with 45 CFR 46, in addition to the Office for Human Research Protections (OHRP), a suspension of IRB/IEC approval must be reported to which of the following?

Sponsor must maintain drug disposition records for how long after marketing approval?

A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?

According to ICH GCP, an electronic data capture (EDC) system must:

An approved investigational device exemption (IDE) permits a device to be:

In accordance with the ICH GCP Guideline, who is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the case report forms and in all required reports?

Which document was created as a response to unethical WWII human experiments?

In accordance with 21 CFR Part 11, in order for an electronic record to be equivalent to a paper record the electronic record must be:

In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?

When can an IRB/IEC review a study using expedited review?

Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?

A nonrandomized study of 30 subjects entitled "A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for the treatment of subjects with chronic arthritis" is an example of a:

In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?

A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard. Before applying this change to all subjects, what must occur?

In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:

Which of the following would be considered an addendum to an investigator's brochure for an unapproved Investigational Product?

Which of the following is an example of an additional protection required when conducting research on children?

An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?

An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?

A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?

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?

Which case history documents must be at both sponsor and site?

According to the CFR, when children who are wards of the state are enrolled into a clinical trial, what is required?