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ACRP CCRC EXAM 2025-2026|WITH QUESTIONS AND
ANSWERS|A+GRADE|
The has developed the Declaration of Helsinki (DoH): ANS:->>> World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of in medical research to protect the life, health, privacy and dignity of the human subject. ANS:->>> the physician (DoH) In medical research, societal/scientific interest should always be prioritized after: ANS:->>> prioritization of the subject's health and well being (DoH) The primary purpose of medical research involving human subjects is to: 2 part answer... ANS:->>>
**1) improve prophylactic, diagnostic and therapeutic procedures
- improve the understanding of the aetiology and pathogenesis of disease** (DoH) The must be independent of the investigator, the sponsor or any other kind of undue influence. ANS:->>> Institutional Review Board/Committee (DoH) The physician should cease any investigation if: ANS:->>> the risks are found to outweigh the potential benefits. (DoH) What is obtained in the place of 'consent' when the subject is deemed legally incompetent (such as a child)? ANS:->>> 1 ) obtain the subject's assent
- obtain the subject's legally authorized representative's consent (ICH-E2A) Definition of Adverse Event (or Adverse Experience)(AE): ANS:->>> any untoward medical occurrence in a patient or
consistent with the applicable product information (e.g. Investigator Brochure ). (ICH-E2A) Definition of Serious Adverse Event: ANS:->>> any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (ICH-E2A) In regards to SAEs, what does the term 'life-threatening' mean? ANS:->>> an event in which the patient was at risk of death at the time of the event; (it does not refer to an event which hypothetically might have caused death if it were more severe) (ICH-E2A) Regarding SAEs, differentiate the difference between the terms 'serious' and 'severe': ANS:->>> Serious: seriousness is determined by the outcome (think
of the definition of SAE) Severity: used to describe the intensity of a specific event (as in mild, moderate, or severe myocardial infarction) Example: a headache can be severe, but is not 'serious' until it results in either death, hospitalization/prolonged hospitalization, birth defect, significant disability. (ICH-E2A) What documents should be used to determine whether an adverse event is expected or unexpected? ANS:->>> **1) Investigator's Brochure
- Reports which add significant information on specificity or severity of a known, already documented serious ADR constitute unexpected events Example: an acute renal failure as a labeled ADR with a subsequent new report of interstitial nephritis.**
"As soon as possible, but no later than 15 calendar days after first knowledge by the sponsor." A subject in a Phase I oncology trial experiences nausea with vomiting after IP infusion which results in an inpatient hospitalization. Nausea with vomiting does not appear in the Investigator's Brochure. The investigator should rate this event as: ANS:->>> A. expected and serious. B. expected and not serious. C. unexpected and serious. D. unexpected and not serious. (C) Which of the following documents are required to be present in the investigator's trial files at the end of the trial? ANS:->>> 1. subject enrollment logs
- IP certificate of analysis
- sample of labels affixed to IP containers
- investigator notification of new IP safety information A. 1 and 3 only B. 1 and 4 only C. 2 and 3 only D. 2 and 4 only (B) A clinical trial is being conducted to determine the safety and tolerability of a new anti-emetic IP. The sponsor expects to enroll 20 subjects. This would be considered a: ANS:->>> A. Phase I trial. B. Phase II trial. C. Phase III trial. D. Phase IV trial (A) A subject has a history of dermatitis. During visit 2 of the trial, the
(B)
From the sponsor's initial receipt of information about an SAE that is serious, unexpected, considered related to the use of the drug but did not result in death and was not considered life- threatening, how long does the sponsor have to notify the regulatory authorities? ANS:->>> A. within 24 hours B. within 7 calendar days C. within 15 calendar days D. within 30 calendar days (C) A CRC reports discovering records in the site's storage area from a trial that closed 4 years ago. Based on the ICH Guidelines regarding trial record retention, which of the following should occur? ANS:->>> A. The sponsor will notify the site after 2 years with record disposition information. B. The site personnel will contact the IRB/IEC to request permission to dispose of the records. C. The site will forward the trial records to the regulatory document
manager of the CRO. D. The sponsor will contact the site when record retention is no longer required. (D) Which of the following are conducted as part of a pre-trial visit? ANS:-
- Evaluate the qualifications of the investigator and staff.
- Confirm the availability of an acceptable monitoring plan.
- Execute two copies of the clinical trial agreement.
- Assess the storage location of IP. A. 1 and 2 only B. 1 and 4 only C. 2 and 3 only D. 3 and 4 only (B) During the trial close-out visit, the CRA is reviewing the investigator's responsibility to retain source documents. Which of
- sponsor-designated form where ECG measurements were transcribed A. 1 and 2 only B. 1 and 3 only C. 2 and 4 only D. 3 and 4 only (B) While conducting an interim monitoring visit, the CRA notices that the IRB/IEC reapproval submission has been completed and a faxed confirmation is present. Which of the following are the MOST appropriate actions for the CRA? ANS:->>> 1. Document the reapproval submission in the monitoring report.
- Request that the PI sign and date the faxed confirmation.
- Ensure the documented IRB/IEC receipt is placed in the regulatory binder.
- Contact the IRB/IEC requesting documentation of receipt.
A. 1 and 3 only B. 1 and 4 only C. 2 and 3 only D. 2 and 4 only (A) Which of the following is considered to be an SAE? ANS:->>> A. skin cancer B. transient hypotension C. treatment at an urgent care center D. a congenital anomaly in a male subject's offspring (D) A trial protocol amendment is required if there is ANS:->>> A. a replacement of a site. B. a site investigator change. C. an increase in the sample size. D. a merger involving the sponsor. (C) While at a monitoring visit, a CRA notes that the first three subjects
- instruct the investigator to reconsent the active subjects with the current, approved ICF.
- discuss with the investigator and have him decide if the subjects should sign a new consent.
- recommend the site document their corrective action plan. A. 1, 2, and 3 only B. 1, 2, and 4 only C. 1, 3, and 4 only D. 2, 3, and 4 only (B) The purpose of trial-specific monitoring procedures is to provide ANS:->>> A. a comprehensive safety review of the IP. B. a small-scale version of company SOPs. C. written guidelines for each individual trial. D. federal regulations and company SOPs in a user-friendly format. (C)
A CRA is at a site and finds an unreported event of death while the subject was involved in the trial. Which of the following should the CRA do? ANS:->>> 1. Discuss the SAE with relevant research staff.
- Contact the IRB/IEC to report the SAE.
- Notify the regulatory authority of a 15-day reportable SAE.
- Report the SAE to the sponsor. A. 1 and 2 only B. 1 and 4 only C. 2 and 3 only D. 3 and 4 only (B) During an initiation visit, the CRA should explain that source documents include: ANS:->>> 1. results of all laboratory tests performed.
A. 1, 2, and 3 only B. 1, 2, and 4 only C. 1, 3, and 4 only D. 2, 3, and 4 only (B) The schedule of monitoring visits is determined by the: ANS:->>> 1. ICH Guidelines.
- regulatory submission guidelines.
- protocol complexity.
- rate of enrollment. A. 1 and 2 only B. 1 and 3 only C. 2 and 4 only
D. 3 and 4 only (D) A CRC informs the CRA by phone that a subject has lost his trial inhaler. Where should the CRA instruct the CRC to document the subject's loss of IP? ANS:->>> 1. source document
- subject identification log
- CRF
- drug accountability log A. 1 and 2 only B. 1 and 4 only C. 2 and 3 only D. 3 and 4 only (B) A subject is participating in a clinical trial where only the pharmacist
