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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 (Q94-Q99):

NEW QUESTION # 94
An IND application must contain all EXCEPT:

Answer: C

Explanation:
* 21 CFR 312.23(a):Requires cover sheet, CMC information, and IB.
* Financial disclosureis required separately under21 CFR 54, not part of IND content.
References:21 CFR 312.23(a); 21 CFR 54.


NEW QUESTION # 95
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?

Answer: D

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 # 96
A company's CEO wants to commercially promote a device under an IDE study. This plan:

Answer: B

Explanation:
* 21 CFR 812.7:Prohibits promotion of investigational devices or claiming safety/effectiveness until FDA approval is granted.
* Investigational devices may only be used in clinical trials, not marketed.
Thus, promotion during an IDE study is anFDA violation.
References:21 CFR 812.7.


NEW QUESTION # 97
In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:

Answer: C

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 # 98
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?

Answer: C

Explanation:
* 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."
* Sponsors must confirm IRB approval before authorizing initiation.
References:ICH E6(R2), §4.4.1.


NEW QUESTION # 99
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