RA Industry Best Practices 2 — Questions and Answers
Question 1: In the ALCOA+ data integrity framework, what does the added "C" stand for?
- Complete (Correct answer)
- Certified
- Confidential
- Controlled
Correct answer: Complete
ALCOA+ adds Complete, Consistent, Enduring, and Available to the original Attributable, Legible, Contemporaneous, Original, Accurate.
Question 2: A research assistant notices an incorrect blood pressure value on a paper source document. What is the correct way to fix it?
- Apply correction fluid and write the right value
- Draw a single line through the error, write the correction, and initial and date it (Correct answer)
- Black out the entry completely and rewrite it beside it
- Remove the page and recopy all data onto a fresh form
Correct answer: Draw a single line through the error, write the correction, and initial and date it
GCP-compliant corrections keep the original entry legible and are attributable and dated.
Question 3: Who is ultimately responsible for signing the delegation of authority log that assigns study tasks to site staff?
- The sponsor's clinical research associate
- The IRB chair
- The principal investigator (Correct answer)
- The lead clinical research coordinator
Correct answer: The principal investigator
The PI delegates trial-related duties and stays responsible for supervising those individuals.
Question 4: Which step must be completed before any study-specific screening procedure is performed on a potential participant?
- Randomizing the participant
- Drawing baseline laboratory samples
- Scheduling all study visits
- Obtaining documented informed consent (Correct answer)
Correct answer: Obtaining documented informed consent
No protocol-specific procedure may be performed until informed consent is obtained and documented.
Question 5: The temperature log shows that the investigational product refrigerator went above its allowed range overnight. What should the research assistant do first?
- Quarantine the affected product and notify the sponsor before any further dispensing (Correct answer)
- Keep dispensing because a short excursion is acceptable
- Throw the product away without recording it
- Move the product to another fridge and continue dispensing
Correct answer: Quarantine the affected product and notify the sponsor before any further dispensing
Product exposed to an excursion is quarantined until the sponsor decides whether it can still be used.
Question 6: According to ICH E6, what is the main purpose of essential documents?
- To meet hospital billing requirements
- To replace the need for monitoring visits
- To allow evaluation of how the trial was conducted and of the quality of the data produced (Correct answer)
- To serve as marketing material for the sponsor
Correct answer: To allow evaluation of how the trial was conducted and of the quality of the data produced
Essential documents show that the investigator, sponsor, and monitor complied with GCP and regulatory requirements.
Question 7: Under 21 CFR 312.62, how long must an investigator keep records for an IND drug study?
- 5 years after the first participant is enrolled
- 1 year after the last participant visit
- 2 years after marketing approval, or 2 years after the investigation is discontinued and FDA is notified (Correct answer)
- Permanently, with no end date
Correct answer: 2 years after marketing approval, or 2 years after the investigation is discontinued and FDA is notified
FDA requires retention for 2 years after approval for the indication, or 2 years after discontinuation and FDA notification.
