CCA CATO Associate Ethics & Good Clinical Practice (GCP) 2 — Questions and Answers
Question 1: Which ethical principle requires that the anticipated benefits of clinical research must justify the risks to participants?
- Autonomy
- Justice
- Beneficence (Correct answer)
- Non-maleficence
Correct answer: Beneficence
Beneficence obligates researchers to maximize benefits and minimize harms so that the study's potential benefits justify the risks.
Question 2: A sponsor discovers a serious unexpected adverse drug reaction mid-trial. Under GCP, the expedited reporting window to regulatory authorities is typically:
- 24 hours
- 7 calendar days for fatal/life-threatening events (Correct answer)
- 30 calendar days
- 15 calendar days for all SUSARs
Correct answer: 7 calendar days for fatal/life-threatening events
Fatal or life-threatening SUSARs must be reported to regulators within 7 calendar days; other SUSARs within 15 calendar days.
Question 3: An IRB/IEC must retain its records of approved studies for at least how long after study completion under ICH E6(R2)?
- 2 years
- 3 years
- 5 years
- As required by applicable regulations, but no less than 3 years (Correct answer)
Correct answer: As required by applicable regulations, but no less than 3 years
ICH E6(R2) states that IRB/IEC records should be retained as required by applicable regulations, with a general minimum of 3 years post-completion.
Question 4: During site selection, a clinical monitor finds that the principal investigator has insufficient time to conduct the study. GCP requires the sponsor to:
- Proceed and provide extra staff
- Select a qualified sub-investigator to replace key tasks
- Not initiate the site (Correct answer)
- Notify the FDA and continue
Correct answer: Not initiate the site
GCP requires sponsors to select only sites where the investigator has adequate time and resources; a site should not be initiated if those conditions are not met.
Question 5: The Declaration of Helsinki's requirement for a 'post-study provision' means that:
- Participants must be compensated financially after the trial
- Sponsors must publish all negative results
- Participants should have access to beneficial interventions identified in the study (Correct answer)
- Data must be archived for future research
Correct answer: Participants should have access to beneficial interventions identified in the study
The Declaration of Helsinki states that participants who benefited from study interventions should have access to them after the study ends.
Question 6: Which GCP document establishes the agreement between the sponsor and the investigator regarding study conduct, confidentiality, and publication rights?
- Clinical Study Report
- Investigator Brochure
- Protocol Amendment
- Clinical Trial Agreement (CTA) (Correct answer)
Correct answer: Clinical Trial Agreement (CTA)
The Clinical Trial Agreement formalizes the responsibilities, financial terms, and rights between sponsor and investigator/institution.
Question 7: Under GCP, source documents are best defined as:
- The final study database after data cleaning
- Original records and certified copies from which CRF data are transcribed (Correct answer)
- The sponsor's protocol and amendments
- IRB approval letters
Correct answer: Original records and certified copies from which CRF data are transcribed
Source documents are the original records (e.g., hospital charts, lab reports) that provide the first-captured data for clinical trial entries.
CCA CATO Associate Ethics & Good Clinical Practice (GCP) 2
Which ethical principle requires that the anticipated benefits of clinical research must justify the risks to participants?