Industry Best Practices Flashcards

A protocol change is needed right away to eliminate an immediate hazard to participants. When can it be implemented?

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.

When should an enrolled participant usually be re-consented?

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.

How many identifiers must be removed to de-identify data under the HIPAA Safe Harbor method?

Answer: 18

The Safe Harbor method requires removing 18 specified identifiers, such as names, dates, and geographic subdivisions smaller than a state.

Which UN number applies to shipping Category B biological substances, such as routine clinical trial blood samples?

Answer: UN3373

UN3373 is used for Biological Substance, Category B, while UN2814 is for Category A infectious substances and UN1845 is for dry ice.

What is the best practice when answering a data query in an electronic data capture (EDC) system?

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.

Why should a site keep a screening log that includes screen failures?

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.

Which document best shows that a site centrifuge or scale produces reliable measurements?

Answer: Current calibration and maintenance records

Calibration and maintenance records show that equipment used for study measurements is in working order.