| Exam Code | CCRP |
| Exam Name | Certified Clinical Research Professional (CCRP) |
| Questions | 130 Questions Answers With Explanation |
| Update Date | July 16,2026 |
| Price |
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According to the ICH GCP Guidelines, what is the purpose of source documents?
A. To establish diverse subject enrollment
B. To validate insurance reimbursement
C. To provide a record of subjects’ investigational medical treatment
D. To validate reports submitted to the IRB/IEC
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?
A. Immediately
B. Within 7 working days
C. Within 10 working days
D. Within 15 working days
Which of the following is considered a source document?
A. The subject instruction sheet
B. Standard operating procedures (SOPs)
C. The protocol
D. Pharmacy dispensing records
What is included in the Statement of Investigator (Form FDA 1572)?
A. A statement disclosing investigator financial interests
B. A statement responding to FDA inspection observations
C. A statement describing preclinical and human safety data
D. A statement agreeing to comply with FDA regulations
After randomization, investigational drug is shipped to site. Who is responsible for accountability?
A. Investigator
B. Research coordinator
C. Investigational pharmacist
D. Sponsor
A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?
A. Number of staff members
B. Available storage square footage
C. Storage facility temperature range
D. Storage cost
The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site’s investigator has a subject actively receiving this study drug. Which of the following is the site investigator’s responsibility to the subject?
A. To discontinue the subject’s study drug
B. To submit this safety update to the regulatory authority
C. To provide the subject with information regarding the significant new findings
D. To give the subject’s contact information to the sponsor in order to allow the sponsor to contact the subject
In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB/IEC will conduct the initial and continuing review of a study?
A. The sponsor
B. The monitor
C. The investigator
D. The study coordinator
In accordance with the CFR, the IRB/IEC membership must have:
A. At least seven individuals
B. A majority of individuals whose primary area of expertise is nonscientific
C. At least one cleric
D. At least one individual who is not affiliated with the institution
An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?
A. FDA
B. Sponsor
C. Research pharmacist
D. OHRP
In determining the classification of risk for a study involving a medical device, it is necessary to consider the:
A. Number of patients to be treated with the device
B. Cost of device
C. Investigators’ prior training and experience
D. Use of the device in the particular study
A study coordinator is developing an informed consent form for the first time. As per the CFR and ICH GCP Guideline, which of the following elements must be included?
A. An explanation of the person to contact at the sponsor for further information regarding research subjects’ rights
B. A note that the qualified investigator could be financially compensated by the sponsor to conduct the clinical trial
C. A statement confirming that the subject has received a copy of the signed consent document
D. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
In accordance with the ICH GCP Guideline, who is responsible for ensuring that all study site personnel working on a clinical trial are qualified to conduct the trial?
A. The sponsor
B. The clinical investigator
C. The clinical research coordinator
D. The study monitor
Upon completion of a study, the investigator should do which of the following?
A. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome
B. Ensure that all payments from sponsor have been received
C. Provide the IRB/IEC a final report, but only if the study has a positive outcome
D. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report
A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?
A. Yes, per protocol
B. Only after sponsor and IRB approval
C. Only after medical monitor approval
D. Only for a short time, then change to placebo
A company’s CEO wants to commercially promote a device under an IDE study. This plan:
A. Requires a large advertising budget
B. Would violate FDA regulations
C. Requires IRB/IEC approval
D. Requires IDE approval
Which of the following identifies content that should be included in a clinical research protocol?
A. IRB/IEC approval and meeting minutes
B. Standard operating procedures for data collection
C. Criteria for the selection of an investigator
D. A summary of findings of nonclinical studies that potentially have clinical significance
According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
A. OHRP
B. Investigator/institution
C. Regulatory authority
D. DSMB
During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?
A. The investigator
B. The IRB/IEC chair
C. The sponsor
D. The CRO
A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?
A. Any amount
B. $5,000
C. $10,000
D. >$25,000
Which of the following elements should NOT influence the investigator’s ability to obtain endpoint data?
A. Participant compliance
B. Complexity of study
C. Length of study follow-up
D. Complexity of CRFs
During an internal compliance review, the site study team identified that a protocol-required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should:
A. Suspend all trial-related activities until the events of the deviation have been mitigated
B. Document and explain the deviation from the protocol
C. Assign another investigator to perform sample collections until an internal investigation is completed
D. Immediately report the observation to the regulatory authority
In a Phase III cardiovascular trial, who is responsible for ongoing clinical trial safety evaluation?
A. IRB/IEC
B. Sponsor
C. FDA
D. Pharmacist
In order to meet recruitment goals, a sponsor is adding a new site to a multi-center study. Which of the following documents should the sponsor obtain from a new site prior to starting research at the site?
A. The site’s SOPs
B. The delegation of duties log
C. The site’s accreditation certificate
D. The IRB/IEC trial approval documentation
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?
A. Obtain IRB/IEC approval
B. Inform all subjects
C. Train sub-investigators
D. Document change in study file
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