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

2. 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!

3. 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