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SOCRA CCRP Exam Syllabus Topics:
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NEW QUESTION # 23
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:
- A. 1 day
- B. 5 working days
- C. 30 working days
- D. 10 working days
Answer: B
Explanation:
Informed consent is a fundamental ethical requirement. If it is violated in a device trial, the FDA requires rapid reporting.
* 21 CFR 812.150(b)(5):States that a sponsor shall submit to FDA "any report of use of a device without obtaining informed consent, within5 working daysafter the sponsor first receives notice of such use."
* This expedited reporting ensures FDA oversight of serious violations and protection of human subjects.
Incorrect options:
* A (1 day) is overly strict and not codified.
* C (10 days) and D (30 days) are too delayed to meet regulatory intent of immediate oversight.
Thus, the correct timeline iswithin 5 working days.
References:
21 CFR 812.150(b)(5).
NEW QUESTION # 24
Upon completion of a study, the investigator should do which of the following?
- A. Provide the IRB/IEC a final report, but only if the study has a positive outcome
- B. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome
- C. Ensure that all payments from sponsor have been received
- D. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report
Answer: B
Explanation:
Investigators must formally close out a trial with the IRB/IEC.
* ICH E6(R2) 4.13.2:"Upon completion of the trial, the investigator/institution should provide the IRB
/IEC with a summary of the trial's outcome."
* 21 CFR 312.66:Reinforces investigator's duty to keep IRB informed throughout study lifecycle.
This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).
Thus, the correct answer isA (Provide final report to IRB/IEC).
References:
ICH E6(R2), §4.13.2 (Final reporting requirement).
NEW QUESTION # 25
Which of the following is one of the responsibilities of an investigator?
- A. Selecting qualified monitors on the basis of training, experience, and expertise
- B. Maintaining accurate and current case histories of study subjects
- C. Updating the investigator brochure with new safety information
- D. Participating in the IRB/IEC voting process for approval of their protocol
Answer: B
Explanation:
Investigators are required to maintain accurate subject records, often referred to ascase histories.
* 21 CFR 312.62(b):"An investigator shall prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation."
* ICH E6(R2) 4.9.0:Reinforces that investigators are responsible for recording, handling, and storing clinical trial data.
Incorrect options:
* B: Investigators may present protocols but cannot vote on IRB approval.
* C: Sponsor responsibility (ICH E6 §5.18).
* D: Sponsors are responsible for IB updates (ICH E6 §7.3.1).
Correct answer:A.
References:
21 CFR 312.62(b).
ICH E6(R2), §4.9.0.
NEW QUESTION # 26
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
- A. OHRP
- B. Site coordinator
- C. Reviewing IRBs/IECs
- D. Investigational pharmacies
Answer: C
Explanation:
* 21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.
* Ensures subjects are protected and sites stop enrollment.
References:21 CFR 312.56(d).
NEW QUESTION # 27
In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records pertaining to the IRB/IEC's review after a trial has been completed?
- A. At least 3 years
- B. Until the regulatory authority has approved the investigational product for use
- C. Indefinitely
- D. At least 15 years
Answer: A
Explanation:
IRBs/IECs must retain records to permit evaluation of compliance.
* ICH E6(R2) 3.4.2:"IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least3 years after completion of the trial." Extended retention (B-D) may occur institutionally, but ICH minimum is3 years.
Correct answer:A (At least 3 years).
References:
ICH E6(R2), §3.4.2.
NEW QUESTION # 28
In accordance with the ICH GCP Guideline, prior to initiating a trial, which of the following should define, establish, and allocate all trial-related duties and functions?
- A. The sponsor
- B. The IRB/IEC
- C. The study coordinator
- D. The institutional administrator
Answer: A
Explanation:
* ICH E6(R2) 5.2.1:"The sponsor is responsible for implementing and maintaining quality assurance and quality control systems... including allocation of trial-related duties."
* Although tasks may be delegated to CROs or site staff, accountability remains with thesponsor.
References:ICH E6(R2), §5.2.1.
NEW QUESTION # 29
In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:
- A. Maintain accurate records throughout retention
- B. Print a complete paper copy
- C. Generate audit trails
- D. Customize access rights
Answer: B
Explanation:
* 21 CFR 11.10:Requires validation, audit trails, secure access, but does not mandate printing capability.
Thus, (D) is the exception.
References:21 CFR 11.10.
NEW QUESTION # 30
A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub-investigator needs to break the blind. Where can the sub-investigator find a description of the unblinding procedure?
- A. The case report form
- B. The informed consent form
- C. The study protocol
- D. The Investigator's Brochure
Answer: C
Explanation:
Unblinding procedures are aprotocol-level responsibilitybecause they involve trial design, safety management, and subject protection.
* ICH E6(R2) 6.0 (Protocol and amendments):Requires the protocol to specify "the treatment(s) and treatment periods, procedures for randomization and blinding, andprocedures for breaking codes."
* ICH E6(R2) 4.7:"The investigator should follow the trial's randomization procedure, if any, and should ensure that the code is broken only in accordance with the protocol." The informed consent (A) explains risks and rights but does not include operational unblinding procedures.
The Investigator's Brochure (B) summarizes preclinical/clinical data but does not dictate site-specific trial management. The CRF (D) is for data capture and has no procedural detail.
Therefore, the correct answer isC (The study protocol), as it outlines unblinding steps and documentation requirements.
References:
ICH E6(R2), §6.0 (Protocol content).
ICH E6(R2), §4.7 (Randomization and unblinding).
NEW QUESTION # 31
Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?
- A. The FDA may inspect them at reasonable times, in a reasonable manner, but may not take copies unless requested with an affidavit
- B. The FDA does not have regulatory authority to inspect them
- C. The FDA may inspect them only if the IRB/IEC formally requests inspection
- D. The FDA may inspect them at reasonable times, in a reasonable manner, and may take copies of IRB
/IEC records
Answer: D
Explanation:
The FDA has full regulatory authority to inspect IRB/IEC records.
* 21 CFR 56.115(b):"The IRB shall permit representatives of the Food and Drug Administration to inspect and copy all records maintained... at reasonable times and in a reasonable manner." Thus, FDA mayinspect and copyIRB/IEC records without requiring an affidavit or invitation. This ensures regulatory oversight and human subject protection.
Incorrect options:
* (A) limits authority incorrectly.
* (C) is false - FDA explicitly regulates IRBs.
* (D) is false - FDA does not need IRB invitation.
Correct answer:B.
References:
21 CFR 56.115(b).
NEW QUESTION # 32
What is included in the Statement of Investigator (Form FDA 1572)?
- A. A statement disclosing investigator financial interests
- B. A statement describing preclinical and human safety data
- C. A statement responding to FDA inspection observations
- D. A statement agreeing to comply with FDA regulations
Answer: D
Explanation:
FormFDA 1572is the investigator's signed agreement to follow regulations.
* 21 CFR 312.53(c)(1)(vi)(c):Requires investigators to sign Form 1572, committing to conduct trials in accordance withFDA regulations (21 CFR 50 & 56).
* The form includes commitments to personally supervise, obtain informed consent, maintain records, and permit FDA inspections.
It does not include financial disclosures (covered under21 CFR 54) or preclinical data (in theIB).
References:21 CFR 312.53(c)(1)(vi)(c).
NEW QUESTION # 33
Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?
- A. 400 mg/m²
- B. 492 mg/m²
- C. 420 mg/m²
- D. 444 mg/m²
Answer: D
Explanation:
370 × 1.20 =444 mg/m².
Accurate dosing calculations are critical for protocol adherence and patient safety.
References:Standard pharmacology dose adjustment principles; ICH E6(R2) §4.5.1.
NEW QUESTION # 34
In accordance with the CFR, the IRB/IEC membership must have:
- A. A majority of individuals whose primary area of expertise is nonscientific
- B. At least seven individuals
- C. At least one cleric
- D. At least one individual who is not affiliated with the institution
Answer: D
Explanation:
IRBs must be diverse and independent to protect human subjects.
* 21 CFR 56.107(d):"Each IRB shall include at least one member whose primary concerns are in nonscientific areas... andat least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution." There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at leastone unaffiliated member (D)to ensure independence.
Thus, the correct answer isD (At least one unaffiliated individual).
References:
21 CFR 56.107(d) (IRB membership requirements).
NEW QUESTION # 35
Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?
- A. The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects
- B. An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial
- C. The act of reviewing and approving the investigational protocol and informed consent document
- D. The planned and systematic actions established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements
Answer: D
Explanation:
Quality assurance (QA)is proactive and systematic, designed to prevent errors and ensure compliance.
* ICH E6(R2) 1.46:Defines QA as "all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements." Option A describes IRB responsibilities, Option C describesaudit, and Option D describes protocol approval processes. OnlyBaccurately matches the ICH definition of QA. QA is distinct fromquality control (QC), which is operational and focused on detection of issues during conduct.
Thus, the correct answer isB.
References:
ICH E6(R2), §1.46 (Definition of Quality Assurance).
NEW QUESTION # 36
A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?
- A. A copy of the final report for the IRB and investigational product shipment records
- B. Printouts of electronic source documents and the remaining investigational product
- C. Informed consent documents and investigational product documentation
- D. Informed consent documents and printouts of electronic source documents
Answer: C
Explanation:
During study closeout, the monitor verifies subject protection, protocol compliance, and investigational product accountability.
* ICH E6(R2) 8.1 & 8.4:Lists essential documents to be verified at closeout, including signed informed consent forms and investigational product accountability records.
* 21 CFR Part 11:Ensures electronic records are valid, so printed copies are not always necessary unless required for auditing.
Thus, the critical items for monitor review at closeout areinformed consent forms(to confirm subject protection) andinvestigational product documentation(to confirm reconciliation and disposition).
Correct answer:D.
References:
ICH E6(R2), §8.1, §8.4.
NEW QUESTION # 37
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 sponsor
- B. The investigator
- C. The IRB/IEC chair
- D. The CRO
Answer: A
Explanation:
The sponsor holds ultimate responsibility for trial oversight and compliance.
* ICH E6(R2) 5.20.1:If noncompliance is discovered, the sponsor must "take prompt action to secure compliance" and, if necessary, terminate participation of the investigator/institution.
* 21 CFR 312.56(b):Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.
While investigators commit to protocol adherence, once deviations are identified,the sponsor must actto safeguard subjects and trial validity.
References:ICH E6(R2) §5.20.1; 21 CFR 312.56(b).
NEW QUESTION # 38
A subject enrolled in a drug clinical trial has withdrawn from the study. In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?
- A. The protocol
- B. The informed consent document
- C. The data safety monitoring plan
- D. The Investigator's Brochure
Answer: A
Explanation:
Theprotocolgoverns all trial conduct, including whether subjects should be replaced when they withdraw.
* ICH E6(R2) 6.0:The protocol must contain "detailed information on trial design, methodology, statistical considerations, and the organization of the trial."
* ICH E6(R2) 6.9.2:The section on "Subject withdrawal or discontinuation" specifies "whether and under what conditions subjects may be replaced." Other documents serve different functions: the DSM plan (A) manages safety oversight, the IB (C) summarizes product background, and the consent form (D) explains subject rights but does not guide study conduct. Only theprotocolprovides the operational answer regarding replacement.
Thus, the correct answer isB (The protocol).
References:
ICH E6(R2), §6.0 (Protocol content).
ICH E6(R2), §6.9.2 (Subject withdrawal/discontinuation).
NEW QUESTION # 39
An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?
- A. Report to sponsor
- B. Report to FDA
- C. None
- D. Report to OHRP
Answer: C
Explanation:
* 21 CFR 54.4(b):Requires disclosureduring the study and for 1 year after completion.
* After three years, no disclosure is required.
References:21 CFR 54.4(b).
NEW QUESTION # 40
A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?
- A. The completed subject identification code list
- B. The master randomization list
- C. The audit certificate
- D. The final trial closeout monitoring report
Answer: A
Explanation:
Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis a key essential document for ensuring traceability while maintaining confidentiality.
* ICH E6(R2) 8.3.21:"Subject Identification Code List - A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period."
* ICH E6(R2) 8.4:Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.
Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.
Thus, the correct answer isB (Completed Subject Identification Code List).
References:
ICH E6(R2), §8.3.21 (Essential documents: Subject identification code list).
ICH E6(R2), §8.4 (Essential documents for trial closure).
NEW QUESTION # 41
After completion of a Phase III trial, which document should IRB/IEC retain?
- A. Investigational product labels
- B. Subject enrollment logs
- C. Occupations and affiliations of IRB members
- D. Sponsor/investigator contracts
Answer: C
Explanation:
* 21 CFR 56.115(a)(5):IRBs must retain records of IRB membership (names, qualifications, affiliations, occupations).
* Other documents (contracts, enrollment logs, product labels) are site or sponsor responsibilities, not IRB's.
References:21 CFR 56.115(a)(5).
NEW QUESTION # 42
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. The ICH Guidelines
- B. The Declaration of Helsinki
- C. The Nuremberg Code
- D. The Belmont Report
Answer: D
Explanation:
TheBelmont Report (1979), issued by the U.S. National Commission, identifiesthree core ethical principles guiding human subject research:
* Respect for Persons(informed consent, autonomy, protection of vulnerable populations).
* Beneficence(maximize benefits, minimize harms).
* Justice(fairness in subject selection and treatment).
* TheNuremberg Code (1947)was developed post-WWII to prevent unethical experiments.
* TheDeclaration of Helsinki (1964, updated)is a World Medical Association document guiding international physician research ethics.
* TheICH Guidelines (1996)outline harmonized regulatory requirements for good clinical practice.
Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.
Thus, the correct answer isD (The Belmont Report).
References:
The Belmont Report (1979), National Commission for the Protection of Human Subjects.
45 CFR 46 (Human Subject Protections).
NEW QUESTION # 43
Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?
- A. No approvals are necessary if no pharmaceutical drugs are involved
- B. The Department of Health and Human Services
- C. The IRB/IEC
- D. The FDA or another regulatory authority
Answer: C
Explanation:
Even if a study does not involve drugs, devices, or biologics, it still involveshuman subjectsand therefore requiresethical review by an IRB/IEC.
* 45 CFR 46.109(a):"An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy."
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects." Quality-of-life (QOL) studies may involve surveys, interviews, or questionnaires, but since they involve human participants, they are subject to human research protection regulations. FDA involvement is not required unless drugs or devices are tested. Similarly, HHS approval is not required unless the study is federally funded.
Thus, the correct answer isC (The IRB/IEC).
References:
45 CFR 46.109(a) (IRB review of research).
ICH E6(R2), §3.1.2 (IRB/IEC role in subject protection).
NEW QUESTION # 44
During an IND study closeout, a monitor discovered remaining investigational product. Which procedures must be followed for disposition?
- A. Dispensing pharmacy's procedures
- B. Sponsor's procedures
- C. Regulatory authority's procedures
- D. IRB/IEC's procedures
Answer: B
Explanation:
* ICH E6(R2) 5.13.3:The sponsor is responsible for the supply, storage, and final disposition of investigational product.
* 21 CFR 312.59:Sponsors must assure return or proper disposition of unused supplies.
* Sites must followsponsor's written proceduresfor reconciliation, return, or destruction, not IRB or pharmacy processes.
References:ICH E6(R2) §5.13.3; 21 CFR 312.59.
NEW QUESTION # 45
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:
- A. Managed within a validated computer system
- B. Restricted to authorized clinical trial personnel
- C. Printed, signed, and dated
- D. Entered into an electronic case report form
Answer: A
Explanation:
21 CFR Part 11governs the use of electronic records and electronic signatures in FDA-regulated research.
* 21 CFR 11.10(a):Requires "validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."
* Validated systems ensure equivalency between electronic and paper records.
While access controls (D) are also mandated, they arepart of system validation, not the defining requirement. Printing/signing paper copies (A) is unnecessary under Part 11. Entry into an eCRF (C) is just one function, not sufficient for compliance.
Thus, the correct answer isB (Managed within a validated computer system).
References:
21 CFR 11.10(a) (System validation requirement).
NEW QUESTION # 46
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. The sponsor
- B. The IRB/IEC
- C. The regulatory authority
- D. The Data Safety Monitoring Board
Answer: A
Explanation:
Audits are part of sponsor quality assurance to ensure trial compliance.
* ICH E6(R2) 5.19.3:"The sponsor's auditing procedures should include the provision of anaudit certificatewhere required."
* ICH E6(R2) 8.2.20:Audit certificates are essential documents generated and retained by the sponsor.
IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsorissues and maintains audit certificates, providing them to sites when appropriate.
Correct answer:D.
References:
ICH E6(R2), §5.19.3.
ICH E6(R2), §8.2.20.
NEW QUESTION # 47
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
Answer: B
Explanation:
* ICH E6(R2) 4.5.1:Investigators must follow the protocol approved by the IRB/IEC.
* Any modification that is not pre-specified must be approved by sponsor and IRB before continuing.
Only deviations eliminating immediate hazard can be done without prior approval; in this case, continuation requires sponsor + IRB agreement.
References:ICH E6(R2) §4.5.1.
NEW QUESTION # 48
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