Apr-2026 SOCRA CCRP Actual Questions and Braindumps
CCRP Dumps To Pass SOCRA Exam in 24 Hours - TestInsides
SOCRA CCRP Exam Syllabus Topics:
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NEW QUESTION # 40
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. Available storage square footage
- B. Number of staff members
- C. Storage cost
- D. Storage facility temperature range
Answer: D
Explanation:
Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:
* ICH E6(R2) 5.13.3:"The sponsor should ensure that investigational products are stored... under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s)."
* ICH E6(R2) 4.6.4:"The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product (s) are used only in accordance with the approved protocol." During site qualification/selection, the monitor evaluates storage conditions - particularlytemperature ranges- to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.
Thus, the correct answer isC (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.
References:
ICH E6(R2), §5.13.3 (Product storage requirements).
ICH E6(R2), §4.6.4 (Investigator product storage responsibilities).
NEW QUESTION # 41
A subject has creatinine 1.6 mg/dL, slightly above eligibility (#1.5). Investigator believes this is normal for size. When can subject be enrolled?
- A. After sponsor revises eligibility and IRB approves amendment
- B. After investigator documents explanation in chart
- C. After repeat test confirms 1.6
- D. After monitor approves deviation
Answer: A
Explanation:
* ICH E6(R2) 4.5.1:"The investigator should conduct the trial in compliance with the protocol approved by IRB/IEC."
* Deviations must not occur unless to eliminate hazard. Eligibility criteria cannot be overridden by investigator opinion.
Thus, enrollment requires protocol amendment and IRB approval.
References:ICH E6(R2), §4.5.1.
NEW QUESTION # 42
When can an IRB/IEC review a study using expedited review?
- A. For protocol changes involving more than minimal risk
- B. For initial review of a study using specimens with identifiers
- C. For minor changes to previously approved protocol
- D. For initial review of Phase III IND protocol
Answer: C
Explanation:
* 21 CFR 56.110(b):IRBs may use expedited review forminor changesin previously approved research.
* Expedited review cannot be used for initial reviews of high-risk protocols or major modifications.
Correct answer isD.
References:21 CFR 56.110(b).
NEW QUESTION # 43
A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB/IEC?
- A. Proof of citizenship
- B. A letter of recommendation from a fellow physician
- C. A copy of medical license
- D. A curriculum vitae
Answer: D
Explanation:
Investigators must provideevidence of qualificationsto conduct the study.
* ICH E6(R2) 4.1.1:"The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial."
* ICH E6(R2) 8.2.10:Essential documents include thecurriculum vitae (CV)or other documents evidencing investigator qualifications, submitted to both sponsor and IRB/IEC.
Proof of citizenship (A) and letters of recommendation (B) are irrelevant. A copy of a medical license (D) may be provided but isnot specifically requiredby ICH. The CV is the universally required document.
Thus, the correct answer isC (Curriculum vitae).
References:
ICH E6(R2), §4.1.1 (Investigator qualifications).
ICH E6(R2), §8.2.10 (Essential documents: CV).
NEW QUESTION # 44
In determining the classification of risk for a study involving a medical device, it is necessary to consider the:
- A. Use of the device in the particular study
- B. Investigators' prior training and experience
- C. Number of patients to be treated with the device
- D. Cost of device
Answer: A
Explanation:
FDA regulations for investigational devices are found under 21 CFR 812. Risk classification determines whether a device is considered Significant Risk (SR) or Non-Significant Risk (NSR). The critical factor is how the device will be used in the specific study.
21 CFR 812.3(m): Defines a "significant risk device study" as one that "is intended as an implant, is purported or represented to be for a use in supporting or sustaining human life, or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject." Risk is judged within the context of the protocol - i.e., use of the device in that particular study (D).
Number of patients (A), device cost (B), or investigator experience (C) are irrelevant to FDA's risk classification. For example, a stent used in an approved indication may be NSR, but if used in a new anatomical location, it may be SR.
Therefore, the correct answer is D. This ensures ethical review bodies and FDA assess safety in the intended clinical context rather than device attributes alone.
References:
21 CFR 812.3(m) (Definition of significant risk device).
FDA Guidance on Significant Risk and Nonsignificant Risk Medical Device Studies.
NEW QUESTION # 45
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?
- A. A printout of the EDC record
- B. The electronic medical record
- C. The EDC record
- D. A printout of the electronic medical record
Answer: C
Explanation:
Source data areoriginal records where data are first recorded.
* ICH E6(R2) 1.51:Defines source data as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial." Since subjects directly enter responses into the EDC, theEDC record itself is the original source document.
EMRs (B, C) and printouts (D) are secondary records.
Correct answer:A (The EDC record).
References:
ICH E6(R2), §1.51 (Definition of source data).
NEW QUESTION # 46
A clinical investigator is planning to conduct a quality of life medical device study in the United States. The study has been designed to comply with the approved indication for use of the device. In this situation, who must approve the investigator's proposed patient recruitment materials?
- A. The FDA
- B. A scientific review board
- C. An IRB/IEC
- D. The Office for Human Research Protections (OHRP)
Answer: C
Explanation:
Recruitment materials must be reviewed to protect subjects from misleading or coercive messaging.
* 21 CFR 56.111(a)(3):IRBs must ensure equitable subject selection.
* ICH E6(R2) 3.1.2:IRBs safeguard rights, safety, and well-being, including review of recruitment strategies.
FDA and OHRP do not approve recruitment materials; responsibility lies withIRB/IEC.
References:21 CFR 56.111(a)(3); ICH E6(R2) §3.1.2.
NEW QUESTION # 47
A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?
- A. Notify enrolled subjects
- B. Ship under dangerous goods requirements
- C. Execute material transfer agreement
- D. Obtain IRB/IEC approval for revised protocol and ICF
Answer: D
Explanation:
* 21 CFR 56.109(a):IRB must review and approve any protocol amendments before implementation.
* ICH E6(R2) 4.5.2:Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.
Thus, site must first obtainIRB approval for revised protocol and ICF.
References:21 CFR 56.109(a); ICH E6(R2) §4.5.2.
NEW QUESTION # 48
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 Nuremberg Code
- C. The Belmont Report
- D. The Declaration of Helsinki
Answer: C
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 # 49
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?
- A. The quality control specialist
- B. The clinical investigator
- C. The IRB/IEC coordinator
- D. The contract research organization monitor
Answer: B
Explanation:
The investigator holds ultimate responsibility for all data reported.
* ICH E6(R2) 4.9.1:"The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports."
* Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.
Correct answer:A (The clinical investigator).
References:
ICH E6(R2), §4.9.1.
NEW QUESTION # 50
Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?
- A. India
- B. Switzerland
- C. Brazil
- D. China
Answer: A
Explanation:
India has aligned national regulations with ICH-GCP.
* DCGI/ICMR Guidelines (India):Explicitly adopt ICH E6(R2) as part of its Good Clinical Practice standards.China and Brazil are harmonizing, but full official adoption is noted in India.
References:Indian GCP Guidelines (2017 revision).
NEW QUESTION # 51
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?
- A. The sponsor
- B. The investigator
- C. The Food and Drug Administration
- D. The contract research organization
Answer: B
Explanation:
Theinvestigatorbears 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 isB (The investigator).
References:
ICH E6(R2), §4.4.1 (Investigator responsibilities).
21 CFR 312.66 (Investigator assurance of IRB oversight).
NEW QUESTION # 52
A sponsor became aware of a new serious adverse event related to a drug. Who must be notified in addition to FDA?
- A. All participating investigators
- B. OHRP
- C. All IRBs/IECs of record
- D. All investigational pharmacists
Answer: A
Explanation:
* 21 CFR 312.32(c)(1)(ii):Sponsors must notifyall participating investigatorsof any serious and unexpected suspected adverse reactions.
* Investigators then inform IRBs and subjects as appropriate.
References:21 CFR 312.32(c)(1)(ii).
NEW QUESTION # 53
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. 30 working days
- B. 1 day
- C. 5 working days
- D. 10 working days
Answer: C
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 # 54
According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
- A. Investigator/institution
- B. Regulatory authority
- C. OHRP
- D. DSMB
Answer: A
Explanation:
* ICH E6(R2) 5.6.1:"The sponsor should ensure agreement from the investigator/institution on the financial aspects of the trial."This ensures transparency in compensation, reimbursement, and budget.
References:ICH E6(R2) §5.6.1.
NEW QUESTION # 55
According to the ICH/GCP Guideline, which of the following should a sponsor provide to the clinical investigator before entering into a clinical trial agreement?
- A. Staff training
- B. The protocol
- C. Proper equipment
- D. Adequate resources
Answer: B
Explanation:
Before an investigator can commit to conducting a trial, they must review thestudy protocol.
* ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.
* ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator's brochure and the current approved protocol.
Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.
References:ICH E6(R2), §§4.2.3, 4.5.1.
NEW QUESTION # 56
Why would a Phase IV study be conducted?
- A. Different marketing strategy
- B. Different schedule of administration
- C. Different off-label population
- D. Different dosage
Answer: C
Explanation:
Phase IV studies (post-marketing) examine real-world safety and effectiveness.
* ICH E8(R1):Describes Phase IV as "studies performed after drug approval to delineate additional information including the drug's risks, benefits, and optimal use."
* They often test drugs innew or broader populationsbeyond original approval.
While dosing and schedules are Phase I-III, Phase IV focuses onnew patient populationsor long-term outcomes.
References:ICH E8(R1).
NEW QUESTION # 57
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
Answer: B
Explanation:
The investigator has ultimate responsibility for site staff qualifications.
* ICH E6(R2) 4.2.4:"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product, and their trial-related duties and functions."
* ICH E6(R2) 4.1.5:Investigator must maintain current documentation of staff qualifications.
While sponsors and monitors oversee compliance, accountability rests with theclinical investigator.
Coordinators may implement duties, but do not hold legal responsibility.
Correct answer:B (The clinical investigator).
References:
ICH E6(R2), §4.2.4.
ICH E6(R2), §4.1.5.
NEW QUESTION # 58
In accordance with the CFR, clinical trial sponsors are required to retain records and reports after a marketing application is approved for at least:
- A. 15 years
- B. 3 years
- C. 2 years
- D. 5 years
Answer: C
Explanation:
TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57 (c)and21 CFR 312.62(c).
* 21 CFR 312.57(c):"A sponsor shall retain the records and reports... for2 years after a marketing application is approvedfor the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified."
* 21 CFR 312.62(c):Investigators also must retain study-related records for2 years following the date a marketing application is approvedor 2 years after the investigation is discontinued.
This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.
Thus, the correct answer isA (2 years).
References:
21 CFR 312.57(c) (Sponsor record retention).
21 CFR 312.62(c) (Investigator record retention).
NEW QUESTION # 59
A research assistant on a study was recently promoted to a clinical research coordinator (CRC) role after one year on the study. In order to fulfill the significant new responsibilities, the CRC completed additional institutional training. According to ICH GCP Guidelines and 21 CFR, which of the following must be filed in the regulatory binder?
- A. A brochure from the training course
- B. The letter documenting the promotion to a CRC
- C. An updated curriculum vitae
- D. An updated performance review summary
Answer: C
Explanation:
The regulatory binder (investigator site file) must contain documents verifying qualifications of all personnel.
These include curricula vitae (CVs), professional licenses, and training certificates.
ICH E6(R2) 4.1.5: "The investigator should ensure that all persons assisting with the trial are qualified by education, training, and experience... Current curriculum vitae and/or other relevant documents evidencing qualifications should be maintained."
21 CFR 312.53(c)(1): Sponsors must select investigators qualified "by training and experience," and investigators must provide sufficient documentation, typically updated CVs.
Letters of promotion (A), training brochures (B), or performance reviews (C) may remain in personnel files but are not required regulatory documents. The only acceptable regulatory proof is an updated CV (D), which reflects the individual's training and qualifications for their new role.
Therefore, the correct answer is D (Updated CV). This ensures compliance with ICH and FDA requirements for staff qualification documentation in clinical research.
References:
ICH E6(R2) Good Clinical Practice, §4.1.5 (Investigator responsibilities for staff qualification).
21 CFR 312.53(c)(1) (Investigator qualifications and documentation).
NEW QUESTION # 60
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 Investigator's Brochure
- B. The data safety monitoring plan
- C. The informed consent document
- D. The protocol
Answer: D
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 # 61
For a study with a significant risk investigational medical device that could optimize the effects of radiation therapy on cancer tumors, the investigational plan states mild burns are an anticipated effect. One subject developed severe burns with blistering. In accordance with the CFR, this effect must be reported to the sponsor and the IRB/IEC as soon as possible and at most how long after the investigator first learns of the effect?
- A. 2 working days
- B. 10 working days
- C. 5 working days
- D. 7 working days
Answer: B
Explanation:
In device trials,unanticipated adverse device effects (UADEs)must be promptly reported.
* 21 CFR 812.150(a)(1):"An investigator shall submit to the sponsor and the reviewing IRB a report of anyunanticipated adverse device effectas soon as possible, but in no event later than10 working days after the investigator first learns of the effect." In this case,severe burns with blisteringgo beyond the anticipated effect of mild burns listed in the investigational plan. Therefore, it qualifies as aUADEand triggers expedited reporting. Options A, B, and C are too short; the regulation specifically mandates a10 working day maximumtimeframe.
Thus, the correct answer isD (10 working days).
References:
21 CFR 812.150(a)(1) (Reporting requirements for investigators).
NEW QUESTION # 62
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 CRO
- B. The sponsor
- C. The IRB/IEC chair
- D. The investigator
Answer: B
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 # 63
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 # 64
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. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report
- C. Provide the IRB/IEC a final report, but only if the study has a positive outcome
- D. Ensure that all payments from sponsor have been received
Answer: A
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 # 65
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