Common use of Quality Plan Clause in Contracts

Quality Plan. The CQA Project Leader will develop a customized Project-specific Quality Plan in partnership with Sponsor. Ideally this contact person will be a CQA representative within Sponsor. The Quality Plan describes the approaches and methodology for the audits and as such, is a component of the Global Project Management Process (GPMP). The plan will include details such as the percentages of sites/patients/data be audited, the timeline of audits, and the plan for generation of individual Audit Report and Certificates. Sponsor will be requested to review and sign off on the plan and any necessary amendments to the original plan, prior to implementation.