Quality Control SOP 3.12 Release Date: 08/10/2015.

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Presentation transcript:

Quality Control SOP 3.12 Release Date: 08/10/2015

What is Quality Control? Periodic operational checks to verify that clinical data is generated, collected, handled, analyzed, and reported according to protocol, SOPs, and GCPs. QC is a tool to confirm all charts meet the quality required. Accurate No Errors No Omissions Records Reconciled with source Good Clinical Practice Develop a PLAN, Develop PROCEDURES, Develop DETERMINATION to DO IT RIGHT, the first time!

The QC Challenge Operational QC The ongoing challenge in managing the quality of clinical data is to continually monitor data collection procedures and data management practices at every level of the study. ensuring that data generated during the study reflect what is specified in the protocol (case report form [CRF] vs. protocol) ensuring that the data analyzed is the data recorded in the CRF Operational QC sampling plan metrics to be documented acceptable quality levels appropriate methods to report and distribute results completion guidelines subject informed (signed informed consent form) subject's eligibility (inclusion/exclusion) protocol compliance compliance with regulations