• Pamela Nelson, RN


In clinical research a quality program that adheres to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) which is universally recognized as a critical requirement to the conduct of research involving human subjects is the ideal state of any quality program.

Quality programs in clinical research are important to the overall conduct, reliability and repeatability of the trial. A big picture view is needed to see the entire project timeline and the processes and procedures that must be followed in order to realize end product or project. Project management must remain objective in planning and reviewing the overall health of a clinical project.

Ensure that there is consistent review of teams conducting projects using guidelines that are adopted at a high level across all agencies. Key areas that should be addressed within project planning and development are:

  • Management of work order/scope changes and amendments

  • Project management for early contract termination

  • Project Launch

  • Project Plan- standardization

  • Monitoring Plan

  • Safety Management Plan (if applicable)

  • Data Management Plan

  • Communication Plan

A quality program measures the results of actions of teams, individuals and processes that are producing a product or service. The data produced from quality reporting procedures can be utilized in a positive way which is to identify potential flaws, repair, identify the cause and mitigate the risk of having the same issue develop again over time. At times, companies may know what issues or indicators for which they want to collect data, but have no idea how to get started or what information should be collected to produce data that is actionable and credible.

Here is a listing of Program quality measures for consideration

•Audit Methodology

•Investigator Site Audits

•Trial Master File Audits

•Database Audits

•Clinical Study Report Audits

•Management of Corrective and Preventative Actions

Bracane Company| Research Service Provider| mail@bracaneco.com | Ph: 888-568-4271


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