Step 2: Conducting a Cancer Prevention Clinical Trial
Data Management and Analysis
The investigator will establish data management support capabilities that ensure appropriate reporting of clinical trials data to DCP, which will meet the following criteria:
- Support achievement of study objectives;
- Are adequate for quality control and analysis; and
- Commensurate with the needs of the study.
DCP will provide the following for data management:
- Centralized clinical trial information system (Oracle Clinical Remote Data Capture, OC-RDC) for use by members of the consortia;
- Remote Data Capture (RDC) module, a user interface that allows research personnel to enter data in electronic case report form (eCRFs) and to manage data over the Internet;
- DCP Requirements for Data Management; (doc, 58kb)
- Reporting tools that will provide real-time access to the clinical data;
- NCI templates for eCRFs that use DCP-approved terms;
- Protocol specific RDC User Manual;
- Training to site staff on RDC data entry; and
- Help Desk support.
The investigator will provide the following for data management:
- CRFs for Remote Data Capture (RDC);
- A Data Management Plan;
- A Quality Assurance Plan;
- Electronic data as specified by DCP;
- Staff for data entry;
- Staff to perform quality control review of electronic data;
- Reports of data as specified by DCP; and
- Final data set for analysis.
Once the database has been finalized in Oracle Clinical, DCP will provide a protocol-specific user manual to the investigator. The manual will provide specific instructions for RDC data entry and data validation and will serve as a quick reference for frequently used RDC functions. The Lead Organization and all Participating Organizations are expected to follow the instructions when entering the data into RDC and resolving data discrepancies in RDC. The instructions will be updated periodically as the protocol and data entry progresses. The Lead Organization will be notified of any updates to the instructions.
