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SOCRA CCRP Exam Syllabus Topics:

TopicDetails
Topic 1
  • 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 2
  • 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.

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q126-Q131):

NEW QUESTION # 126
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?

Answer: D

Explanation:
Investigators are obligated to inform subjects ofnew informationthat may affect their willingness to continue.
* ICH E6(R2) 4.8.2:"If new information becomes available that may be relevant to a subject's willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner."
* 21 CFR 50.25(b)(5):Consent must include a statement that "significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided." Thus, the investigator mustcommunicate new risk information to the subject.
Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor's role. Sharing subject contact with sponsor (D) would violate confidentiality.
Correct answer:C.
References:
ICH E6(R2), §4.8.2.
21 CFR 50.25(b)(5).


NEW QUESTION # 127
An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?

Answer: B

Explanation:
* 21 CFR 56.109(a):IRBs must review all changes to informed consent before implementation.
* ICH E6(R2) 4.8.2:If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.
Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.
References:21 CFR 56.109(a); ICH E6(R2) §4.8.2.


NEW QUESTION # 128
If a subject experiences a serious adverse event related to the study drug and only minimal information is available, the investigator must submit the information to the:

Answer: B

Explanation:
* ICH E6(R2) 4.11.1:Investigators must "immediately report all serious adverse events to the sponsor except for those the protocol identifies as not requiring immediate reporting."
* IRB must also be informed promptly per21 CFR 312.64(b).
* Follow-up information is submitted later as available.
References:ICH E6(R2), §4.11.1; 21 CFR 312.64(b).


NEW QUESTION # 129
Upon completion of a study, the investigator should do which of the following?

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 # 130
When can an IRB/IEC review a study using expedited review?

Answer: B

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 # 131
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