How to Create an Audit Plan For Clinical Trials

Want to know how to create an audit plan for clinical trials? It is only a good business practice to audit a company's quality systems -internally and externally. These audits are conducted by a Quality Assurance person. The sponsor, CRO (if applicable), ethics committees, central laboratory (if applicable) and clinical investigator sites are major players during clinical trials and it is important to have documentation showing they were qualified to do their respective tasks. Here is how one should create an audit plan for clinical trials and assess compliance.

Things You'll Need

• Basic knowledge about clinical research
• Computer
• Project Planning software (at a minimum Word or Excel)
• Knowledge about the company's goals
• Telephone

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Instructions

• 1

  Know your company's goals.

  Quality Assurance (QA) is like the "police" of the company. Their main function is to keep the company out of trouble with the FDA. I always tell my CEO that I come to work to keep him out of jail. I give him the knowledge he needs to stay out of jail, now if it is not heeded, oh well. Non-compliance can also be costly in many ways in the pharmaceutical and biotechnology industry. Therefore, companies hire QA to learn the regulations, stay current with regulations and regulatory trends so they can keep the company out of trouble. This is why a good QA person knows the company's goals and plans their audits to support the company.

• 2

  Know your resources.

  You can't do anything until you know what you are working with. Do you have sufficient staff to do everything required to be compliant? If not, convince your management to increase your head-count or allow you to out source. If management doesn't agree to either, choose the areas that could get the company in the most trouble and focus on them. In the case of clinical trials; I suggest that the investigator site and the pharmaceutical manufacturer can probably cause the company the most damage. Focus on auditing these two groups.

• 3

  Create an audit objective.

  The audit objective is to determine compliance with approved procedures. These approved procedures include internal procedures, contracts, and government and state regulations. For example, a doctor would be audited for compliance with the protocol, regulations and investigational plan. A drug manufacturer would be audited for compliance with the manufacturing software requirements, equipment validation and qualification, master drug file, approved processes, SOPs (standard operating procedures) and regulations. A sponsor would be audited for clinical trial management, clinical data management, adequate monitoring and overall handling of clinical trial safety profiles.

• 4

  Define the audit scope.

  The audit scope would apply to all personnel involved with your project.

• 5

  Develop the actual audit plan.

  The audit plan will specify the number of audits to be conducted, the days audit will occur, and the name of the individual who will conduct the audit. This part of the planning process is conducted in conjunction with your clinical research department management. You work your audit schedule around their schedule to minimize personnel conflicts and ensure the clinical trial run smoothly. The audit plan is agreed to by the auditee and may change throughout the year. Therefore, it is clearly stated that dates and times are subject to change.