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SOCRA CCRP Exam Syllabus Topics:

Topic	Details
Topic 1	Research Study Start-Up: This section of the exam measures the skills of Clinical Research Coordinators and covers the initial planning and setup of a clinical trial. It involves coordinating the development of the study protocol, ensuring it considers ethical guidelines and regulatory pathways like IND or IDE. It also includes creating essential study documents like informed consent forms and case report forms. The domain covers obtaining necessary approvals from stakeholders like the IRB and sponsor, selecting study sites, training staff, and ensuring the study's compliance with various laws. Additionally, it involves obtaining the research product and preparing all necessary tools and documentation for the study's commencement.\|Research Study Implementation: This section of the exam measures the skills of Clinical Research Associates and covers the active management and execution of the clinical trial. It focuses on following the study protocol and standard operating procedures, managing the investigational product, and ensuring ongoing regulatory compliance. The domain includes identifying, documenting, and reporting any study anomalies such as adverse events or protocol deviations. It also involves managing subject recruitment, consent, and retention, as well as maintaining all study records and essential documents. Furthermore, it covers communicating with all study stakeholders and participating in study audits to ensure quality and adherence to regulations.
Topic 2	Research Study Closure: This section of the exam measures the skills of Clinical Research Coordinators and covers the activities required to properly conclude a clinical trial. It involves participating in the study closeout visit to verify documentation and account for the investigational product. The domain also includes developing and submitting final closure reports to the IRB, study sponsor, regulatory authorities, and clinicaltrials.gov. Finally, it covers the procedures for archiving study records.

Topic

Details

Topic 1

Research Study Start-Up: This section of the exam measures the skills of Clinical Research Coordinators and covers the initial planning and setup of a clinical trial. It involves coordinating the development of the study protocol, ensuring it considers ethical guidelines and regulatory pathways like IND or IDE. It also includes creating essential study documents like informed consent forms and case report forms. The domain covers obtaining necessary approvals from stakeholders like the IRB and sponsor, selecting study sites, training staff, and ensuring the study's compliance with various laws. Additionally, it involves obtaining the research product and preparing all necessary tools and documentation for the study's commencement.|Research Study Implementation: This section of the exam measures the skills of Clinical Research Associates and covers the active management and execution of the clinical trial. It focuses on following the study protocol and standard operating procedures, managing the investigational product, and ensuring ongoing regulatory compliance. The domain includes identifying, documenting, and reporting any study anomalies such as adverse events or protocol deviations. It also involves managing subject recruitment, consent, and retention, as well as maintaining all study records and essential documents. Furthermore, it covers communicating with all study stakeholders and participating in study audits to ensure quality and adherence to regulations.

Topic 2

Research Study Closure: This section of the exam measures the skills of Clinical Research Coordinators and covers the activities required to properly conclude a clinical trial. It involves participating in the study closeout visit to verify documentation and account for the investigational product. The domain also includes developing and submitting final closure reports to the IRB, study sponsor, regulatory authorities, and clinicaltrials.gov. Finally, it covers the procedures for archiving study records.

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q75-Q80):

NEW QUESTION # 75
Which of the following identifies content that should be included in a clinical research protocol?

A. IRB/IEC approval and meeting minutes
B. Criteria for the selection of an investigator
C. Standard operating procedures for data collection
D. A summary of findings of nonclinical studies that potentially have clinical significance

Answer: D

Explanation:
Theprotocolmust provide scientific rationale, including prior nonclinical findings that justify human research.
* ICH E6(R2) 6.2.2:"The protocol should include... a summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial." Other listed options belong elsewhere:
* IRB approvals (A) are separate administrative records.
* SOPs for data collection (B) are sponsor-level procedural documents.
* Investigator selection (C) is a sponsor's responsibility, not protocol content.
Thus, the correct answer isD (Summary of nonclinical findings with clinical relevance).
References:
ICH E6(R2), §6.2.2 (Protocol contents).

NEW QUESTION # 76
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. Storage facility temperature range
C. Available storage square footage
D. Storage cost

Answer: B

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 # 77
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. Within 10 working days
B. Within 15 working days
C. Within 7 working days
D. Immediately

Answer: D

Explanation:
ICH requiresimmediatereporting of all SAEs to the sponsor (except those protocol-identified as not requiring immediate reporting). Exact extract:
* ICH E6(R2) 4.11.1: "The investigatorshould report all serious adverse events immediately to the sponsorexcept for those SAEs that the protocol... identifies as not needing immediate reporting." Therefore, "Immediately" (A) is correct. The other timeframes are not aligned with ICH GCP for initial SAE notification from investigator to sponsor.
References:
ICH E6(R2) Good Clinical Practice, §4.11.1 (Safety reporting by investigators).===========

NEW QUESTION # 78
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 informed consent form
B. The case report 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 # 79
Which case history documents must be at both sponsor and site?

A. Signed informed consent forms
B. Medical records
C. Case report forms (CRFs)
D. Study visit notes

Answer: C

Explanation:
* ICH E6(R2) 1.11:CRFs are documents used to record protocol-required data reported to sponsor.
* Sites keep originals; sponsor retains copies.Consent forms and medical records stay at site only.
References:ICH E6(R2), §1.11.

NEW QUESTION # 80
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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q75-Q80):

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