Data Management Overview
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Protocol Development
CTDD Data Managers are involved very early in the protocol development process. They collaborate with key members of the study team such as the Biostatistician and Study Chair or Sponsor to review and update the protocol document. This team approach ensures consistency of sections affecting data management processes such as eligibility, study calendar, forms due section, and overall protocol flow.
Data Management will collaborate with the Sponsor’s Interactive Response Technology (IRT) vendor to integrate the registration and randomization system with the selected EDC.
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Case Report Form Lifecycle Management
The CTDD has experience developing and curating standardized common data element (CDE) eCRFs and CDASH compliant forms for the collection of wide range of required assessments including dose-limiting toxicity assessment, adverse events, and drug administration, among many others. Standardized forms can be developed using common data elements (CDE) from the NIH CDE repository or CDASH standard content from the Clinical Data Interchange Standards Consortium to ensure consistent data collection across studies and sites. Data Management can leverage the robust global library of case report forms which were created in accordance with the data standards mentioned above. CRFs will be supported by a comprehensive set of CRF Completion Guidelines which can serve as an aid to the partner’s sites during the data entry process.
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Data Integrity & Quality Control
The CTDD has a proven track record of providing comprehensive data management quality control and quality assurance programs to ensure high data integrity and timely data for analysis.