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Auditor’s Documentation

Auditor’s Documentation. Office of Research Education and Regulatory Management. Don’t put people of the defensive …. No labs were done CBC missing Unable to locate CBC. Provide Evidence and Information…. Wrong Date on consent Form.

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Auditor’s Documentation

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  1. Auditor’s Documentation Office of Research Education and Regulatory Management

  2. Don’t put people of the defensive… No labs were done CBC missing Unable to locate CBC

  3. Provide Evidence and Information… • 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.

  4. Reference the Protocol Sections… 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.

  5. Writing Tips…Remember “B3” Be clear and to the point Be precise Be accurate

  6. 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.

  7. 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.

  8. 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.

  9. Kristin’s Top Ten Hints…. If you are going to tell the team they must do something then understand the rationale for doing so.

  10. Thoughts and Questions…

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