How to Build Quality Into Your Clinical Trials With Monitoring & Auditing

Inadequate monitoring continues to be the top deficiency cited in FDA inspections of clinical trials, according to the Medical Device and Diagnostic Industry Magazine. A good study should begin monitoring after a few subjects have been treated in the trial to make sure those involved understand the trial and are following the protocol. By monitoring early in the trial, you can also immediately catch mistakes, which could save the trial in the long run. A predetermined strategy for monitoring and auditing should be laid out before a trial begins.

Things You'll Need

• Trial subjects
• Consent forms
• Institutional review board
• Auditing plan
• Auditing schedule
• Case report forms

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Instructions

• 1

  Begin the monitoring process by making sure that all subjects in the clinical trial have signed an informed consent and that the forms were reviewed and approved by an institutional review board. Perform this step before beginning a trial, and do not begin until a form is signed and approved for each trial subject.

• 2

  Set up an auditing plan for the clinical trial; such as how often someone should audit the trial; what days and times the audits will take place; the name of the person who will perform the audit each of those days; what that person will check for in each of the audits. Create a schedule, for the person performing the audit, to check off once they've completed the process.

• 3

  Set up auditing visits throughout the trial, beginning after the first few subjects have begun the trial. At each audit, check for continual protection of the subjects --- including continued consent, periodic reviews of the study and private information protection. Then, check for continued conformity between the initial plan of the trial and the actions of the study. If you find a lack of conformity, fix the issue before continuing the trial.

• 4

  Complete case report forms after each auditing session. Keep track of actions, observations and conclusions, using completeness and accuracy. The National Academies Press recommends only keeping track of data that is directly related to the outcome of the trial. This will allow less room for error.