RA Industry Best Practices 3 — Questions and Answers
Question 1: A protocol change is needed right away to eliminate an immediate hazard to participants. When can it be implemented?
- Only after the sponsor approves it in writing
- Before IRB approval, provided it is reported to the IRB promptly afterward (Correct answer)
- Never without prior IRB approval
- Only after FDA reviews the amendment
Correct answer: Before IRB approval, provided it is reported to the IRB promptly afterward
Changes that eliminate apparent immediate hazards may be made before IRB review and must be reported promptly.
Question 2: When should an enrolled participant usually be re-consented?
- Every time they come in for a visit
- Only when they change their address
- When new information emerges that may affect their willingness to continue (Correct answer)
- Only at the final study visit
Correct answer: When new information emerges that may affect their willingness to continue
Participants must be told about new findings relevant to their continued participation, usually by a revised, IRB-approved consent form.
Question 3: How many identifiers must be removed to de-identify data under the HIPAA Safe Harbor method?
- 10
- 12
- 16
- 18 (Correct answer)
Correct answer: 18
The Safe Harbor method requires removing 18 specified identifiers, such as names, dates, and geographic subdivisions smaller than a state.
Question 4: Which UN number applies to shipping Category B biological substances, such as routine clinical trial blood samples?
- UN1845
- UN3373 (Correct answer)
- UN2814
- UN3291
Correct answer: UN3373
UN3373 is used for Biological Substance, Category B, while UN2814 is for Category A infectious substances and UN1845 is for dry ice.
Question 5: What is the best practice when answering a data query in an electronic data capture (EDC) system?
- Change the value to whatever the query suggests
- Answer from memory to save time
- Close the query without answering if the data look reasonable
- Confirm the value against the source document and record a clear response (Correct answer)
Correct answer: Confirm the value against the source document and record a clear response
Every query response and data change has to be supported by source documentation.
Question 6: Why should a site keep a screening log that includes screen failures?
- To record all screened candidates and the reasons they were not enrolled (Correct answer)
- To track how participants are paid
- To replace the enrollment log
- To list adverse events that happen before consent
Correct answer: To record all screened candidates and the reasons they were not enrolled
Screening logs show recruitment activity and eligibility decisions and help detect possible selection bias.
Question 7: Which document best shows that a site centrifuge or scale produces reliable measurements?
- The manufacturer's sales brochure
- Current calibration and maintenance records (Correct answer)
- A note from the coordinator saying it works
- The protocol synopsis
Correct answer: Current calibration and maintenance records
Calibration and maintenance records show that equipment used for study measurements is in working order.
