Quality Assurance Activities for C3D from Outside Sites When CCR Is the Coordinating Center
Next Review Date: 07/2010
Version #: 1
Review Interval Period: Biennial
Approved Version #: 1 Date: 07/2008
Purpose: To define Quality Assurance activities for C3D for outside sites when CCR is the Coordinating Center
STEP 1: Data Entry at Participating Site
- Data will be entered by identified Data Entry personnel at remote sites.
STEP 2: Remote Quality Control at Outside Site
- Data will be Verifiedby personnel independent of Data Entry staff at remote sites.
- Note: Participating sites may not have the same research team structure as the CCR. A non-Research Nurse team member may verify the data.
STEP 3: Quality Assurance Checks by CCR Study Coordinator
- Data entered in C3D by outside sites should be reviewed by CCR Study Coordinator.
- CCR Study Coordinator should review data in C3D to ensure data is being entered by each site per the timeline outlined in the protocol.
- CCR Study Coordinator should review the data for missing data, or the incorrect use of CRFs.
- CCR Study Coordinator should contact the sites with any data issues.
STEP 4: Monitoring Activities at Outside Site
- Protocol monitoring will be conducted per the protocol.
STEP 5: Data Clarification Routing
- Monitors will use the Approval functionality to track monitoring activities.
- Monitor will be able to create Manual Discrepancies to be resolved by the Site Study Coordinator/DM.