Exam (elaborations)
CCRC Module 3 GCP for the Experienced Clinical Research Professional
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CCRC Module 3 GCP for the Experienced Clinical Research Professional
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Solution 2024/2025Pepper
CCRC Module 3: GCP for the Experienced
Clinical Research Professional
The ICH for GCP describes the responsibilities of these 4 groups: ANS✔✔ Sponsors
Investigators
Institutional Review Boards
Independent Ethics Committees
The International Council on Harmonisation Guidelines for Good Clinical Practice describes the responsibilities of
sponsors, investigators, and institutional review boards, as well as independent ethics committees in order to: [2
Reasons] ANS✔✔ 1. Safeguard the safery and well-being of trial subjects.
2. Ensure the scientific integrity of the study data.
Per this ICH guideline, the conduct of any clinical research trial is ultimately the responsibility of the ___. ANS✔✔ Per
ICH E6, the investigator has full responsibility.
The investigator can ___ various trial related duties and tasks to any qualified staff in order to ensure good ____ _____.
ANS✔✔ Delegate; good trial conduct.
In order to ensure good trial conduct, the investigator may delegate various trial tasks and duties presented in this
guideline to any qualified staff. Qualified staff could include: ANS✔✔ Clinical research coordinators, clinical research
nurses, clinical trial assistants, pharmacists, etc.
Investigator(s) should be qualified by education, training, and __ to assume responsibility for the proper conduct of the
trial, meet all qualifications specified by the applicable regulatory requirement(s), and provide evidence through up-to-
date curriculum vitae and/or other relevant documentation. ANS✔✔ Experience
The investigator and ____ should permit monitoring and auditing by the sponsor, and inspection by the appropriate
regulatory authority(ies). ANS✔✔ Institution
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Pepper
The investigator and institution should permit monitoring and auditing by the _____, and inspection by the appropriate
___. ANS✔✔ Sponsor; Regulatory Authorities
It is recommended that the investigator inform the subject's ___ about the subject's participation in the trial if the
subject has a _____ and if the subject agrees to the ____ being informed. ANS✔✔ Primary physician
Although a subject is not obliged to give his/her reasons for prematurely withdrawing from a trial, the investigator
should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's ____. ANS✔✔ Rights
Where allowed/required, the investigator/institution may/should assign some or all of the investigator's/institution's __
for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist/appropriate individual who's
under the supervision of the investigator/institution. ANS✔✔ Duties
Neither the investigator, nor the trial staff, should coerce or unduly ____ a subject to participate or to continue to
participate in a trial. ANS✔✔ Influence
The investigator/person they designated, should fully inform the subject or, if the subject is __ to provide informed
consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written
information and the approval/ favorable opinion by the IRB/IEC. ANS✔✔ Unable.
The language used in the oral and written information about the trial, including the written informed consent form,
should be as non-technical as practical and should be ___ to the subject or the subject's legally acceptable
representative and the impartial witness, where applicable. ANS✔✔ Understandable
The investigator should ___ written summaries of the trial status to the IRB/IEC annually, or more frequently, if
requested by the IRB/IEC. ANS✔✔ Submit
The ___ should submit written summaries of the trial status to the ___ annually, or more frequently, if requested by the
___. ANS✔✔ Investigator; IRB/IEC
All ___ adverse events should be reported immediately to the Sponsor except for those that the protocol or other
document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should
be followed promptly by ____. ANS✔✔ Serious; Detailed, written reports.
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Pepper
Immediate/follow-up reports should ID subjects by their unique trial code numbers rather than their name, ID numbers,
and/or addresses. The investigator should also comply with the applicable __ requirement(s) related to the reporting of
unexpected serious ADRs to the regulatory authorities/IRB/IEC ANS✔✔ Regulatory
Immediate/follow-up reports should ID subjects by their ____rather than their name, ID numbers, and/or addresses.
ANS✔✔ Unique trial code numbers
The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of ____ to
the regulatory authorities/IRB/IEC. ANS✔✔ Unexpected serious ADRs
List the most significant mistakes made by investigators during the course of clinical trials: [8 items] ANS✔✔ 1. Subject
enrollment: selection criteria not complied with
2. Protocol violations that were committed and negatively impacted subject safety.
3. Site staff did not have the appropriate trainings/qualifications.
4. Source documents not handled properly: not documented, discrepancies with CRFS, data
corrections/changes/falsified.
5. Informed consent process was inadequate or not used.
6. Essential documents were incomplete or missing.
7. Problems with storage, dispensation, retrieval, or destruction of the investigational product.
8. Assessments of efficacy and safety were not conducted according to the protocol.
While recruiting subjects, these 3 things related to that are important for trial planning and execution: ANS✔✔ 1.
Accurate prediction of trial subject recruitment.
2. Recruitment of eligible subjects according to the approved plan.
3. Retention of subjects.
Predicting subject recruitment, retaining subjects, and recruiting only eligible subjects are factors that can affect these 4
items of a trial: ANS✔✔ 1. Timing and duration of the trial.
2. Number of subjects and sites.
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