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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q123-Q128):

NEW QUESTION # 123
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?

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 # 124
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?

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 # 125
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 # 126
During the closeout visit, a monitor is completing the documentation of reconciliation of investigational product. All packaging, as well as the used and unused investigational product, are being returned to the sponsor for disposition. Which of the following documents wouldNOTbe required to be filed at the research site?

Answer: D

Explanation:
Investigators must document the receipt, use, return, or alternative disposition of investigational product (IP).
* ICH E6(R2) 4.6.3:Requires investigators to maintain records of IP delivery, inventory, use by subjects, and return/disposition.
* ICH E6(R2) 8.2.14-8.2.16:Essential documents include shipment records, accountability logs, and inventory records.
However,certificates of destructionare generated and retained by the sponsor (or authorized destruction facility), not required at the site unless the destruction occurred there. In this scenario, all IP was returned to the sponsor, so no destruction certificate would exist at the site.
Thus, the correct answer isD (Certificate of destruction).
References:
ICH E6(R2), §4.6.3 (Investigator product accountability).
ICH E6(R2), §8.2.14-8.2.16 (Essential documents).


NEW QUESTION # 127
According to ICH GCP, sponsor-specific essential documents must be retained until:

Answer: B

Explanation:
* ICH E6(R2) 5.5.12 & 8.1:Essential documents must be retained2 years after the last approval of a marketing application in an ICH region and until no applications are pending, or2 years after discontinuation of development.
This ensures availability for inspection.
References:ICH E6(R2) §§5.5.12, 8.1.


NEW QUESTION # 128
......

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