Office of Research Education and Regulatory Management

No labs were done

CBC missing

Unable to locate CBC

Wrong Date on consent Form

Dictation by Research Nurse on 6/1/07 reflects that subject signed consent on 6/1/07 however, subject’s signature date on informed consent is 6/3/07.

Per section 5.0 of the protocol, the subject should be on birth control at the time of enrollment. Unable to locate documentation of birth control.

Be clear and to the point Be precise Be accurate

Kristin’s Top Ten Hints….Kristin’s Top Ten Hints….10. Review team needs to have had experience

“walking in the research team’s shoes.”

9. Pick your battles.

8. If you have a poorly written protocol expect a poor

audit outcome.

Kristin’s Top Ten Hints….Kristin’s Top Ten Hints…. 7. Do not have a “My way or the highway”

complex.

6. Emphasize that you are not the “protocol police.”

You are there as a part of the research team.

5. Have humility. Admit that you don’t know everything.

It is better to say “I will get back to you” than to give bad advice.

Kristin’s Top Ten Hints….Kristin’s Top Ten Hints…. 4. Let the team know you don’t expect them

to be perfect.

3. Listen to the site and consider what they are telling

you. They are often have more expertise in the disease being studied then the monitor/auditor.

2. Look for the “root of the cause. “ It doesn’t work to just

put a Band-Aid on the problem.

Kristin’s Top Ten Hints….Kristin’s Top Ten Hints….

If you are going to tell the team they must do something then understand the rationale for doing so.

Thoughts and Questions…