The BioCAB production group
has the responsibility for all project deliverables. BioCAB’s
use of standard systems, processes and procedures significantly
reduces the cost of project management without compromising
the quality or timeliness of the deliverables. BioCAB’s
high quality standardized, validated and tested deliverables
are consistent from project to project. Consequently, the
client’s cost and effort to monitor production and
quality of deliverables is significantly reduced.
The following is a list of the BioCAB
Data Management, Statistical Programming and Project Status
Deliverables:
Data Management
- Draft CRF Design and Final CRF *
- Annotated CRF
- CRF Completion Guidelines
- Permissible Clarification Document *
- Final Data Structure *
- Edit Check Specification *
Database Lock and Delivery Reports
- Coded Terms for Final Medical Review *
- Database QC Report
- Report of Permissible Clarifications Database Updates
- Notification of Database Close and Lock
Statistical Reporting
- Statistical Analysis Plan *
- Draft and Final Tables, Listing and Figures *
- Statistical Report *
- Final Project Data in SAS format
Monthly Status Reports
- Monthly DCF Status Report
- Monthly Data Entry Status and Tracking Report
- Monthly Budget Analysis and Invoicing Detail
* Requires client approval
