RA Industry Best Practices 3

Question 1

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

Accepted Answer

Before IRB approval, provided it is reported to the IRB promptly afterward

Answer

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?

Accepted Answer

When new information emerges that may affect their willingness to continue

Answer

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?

Accepted Answer

18

Answer

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?

Accepted Answer

UN3373

Answer

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?

Accepted Answer

Confirm the value against the source document and record a clear response

Answer

Every query response and data change has to be supported by source documentation.

RA - Certified Research Assistant Practice Test