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Our Data Management department is responsible for developing a Data Management Plan (DMP) for each project, which
describes and documents the following data management components/activities that are monitored throughout the course
of the study:
- Case Report Form (CRF) Development, including annotated CRFs and CRF completion guidelines.
- Clinical Data Management System (CDMS): requirements, development, validation plan and user manual.
- External Data Processing and Data Transfer Specifications
- Data Coding Specifications, Data Dictionary and Data Validation Specifications
- Change Management Guidelines
- Performance and Safety Monitoring Report Specifications
- Training Activities that align participant recruitment and retention procedures with the protocol, Manual of Operations (MOO) and CDMS.
- Data Entry Procedures
- Serious Adverse Event (SAE) Reconciliation
- Database Lock and Archiving Procedures
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