How Do You 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. 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
