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SOCRA CCRP Exam Syllabus Topics:
Topic
Details
Topic 1
Topic 2
SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q95-Q100):
NEW QUESTION # 95
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
Answer: D
Explanation:
Serious adverse events are subject to expedited reporting requirements.
* ICH E2A 3.2.2:"Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than7 calendar daysafter first knowledge."
* ICH E2A 3.2.3:Other serious unexpected events must be reported within 15 days.
Thus, the 7-day rule applies tolife-threatening and unexpected events(as in this case).
Correct answer:B (7 days).
References:
ICH E2A, §3.2.2.
NEW QUESTION # 96
Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?
Answer: C
Explanation:
Even if a study does not involve drugs, devices, or biologics, it still involveshuman subjectsand therefore requiresethical review by an IRB/IEC.
* 45 CFR 46.109(a):"An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy."
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects." Quality-of-life (QOL) studies may involve surveys, interviews, or questionnaires, but since they involve human participants, they are subject to human research protection regulations. FDA involvement is not required unless drugs or devices are tested. Similarly, HHS approval is not required unless the study is federally funded.
Thus, the correct answer isC (The IRB/IEC).
References:
45 CFR 46.109(a) (IRB review of research).
ICH E6(R2), §3.1.2 (IRB/IEC role in subject protection).
NEW QUESTION # 97
A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?
Answer: C
Explanation:
During study closeout, the monitor verifies subject protection, protocol compliance, and investigational product accountability.
* ICH E6(R2) 8.1 & 8.4:Lists essential documents to be verified at closeout, including signed informed consent forms and investigational product accountability records.
* 21 CFR Part 11:Ensures electronic records are valid, so printed copies are not always necessary unless required for auditing.
Thus, the critical items for monitor review at closeout areinformed consent forms(to confirm subject protection) andinvestigational product documentation(to confirm reconciliation and disposition).
Correct answer:D.
References:
ICH E6(R2), §8.1, §8.4.
NEW QUESTION # 98
A study coordinator is preparing an IRB submission for a Phase II oncology study. Which document must be included?
Answer: C
Explanation:
* ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998):Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.
* CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.
References:ICH E6(R2) §3.1.2; FDA Recruitment Guidance, 1998.
NEW QUESTION # 99
Which of the following would be considered an addendum to an investigator's brochure for an unapproved Investigational Product?
Answer: D
Explanation:
The IB must be updatedas new significant safety information emerges.
* ICH E6(R2) 7.3:"The sponsor should revise the IB as soon as new, significant information becomes available."
* ICH E2A:Requires sponsors to reportSuspected Unexpected Serious Adverse Reactions (SUSARs) in expedited reports and include them inIB updates or addenda.
A SUSAR report (B) represents new, unexpected, and serious safety information not previously documented, and therefore warrants inclusion as anIB addendumuntil the IB is formally updated.
Revised consent forms (A) are submitted to IRBs, not IBs. Site-specific SAE reports (C) remain at site
/sponsor level, not in the IB. Product monograph updates (D) apply to approved products, not investigational ones.
Thus, the correct answer isB (SUSAR report).
References:
ICH E6(R2), §7.3 (Updating the Investigator's Brochure).
ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
NEW QUESTION # 100
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