Governing and Maintaining Standards for Collecting Clinical Data
Setting Up Standards for Success
- Team Effort and Organizational Buy-In: Establishing standards requires a team effort and strong executive support. Involving representatives from stats, clinical, medical, and data management teams ensures alignment.
- Right People and Codification: Identify individuals with organizational tendencies towards data standards and codify decisions as you go, building a library of standards over time.
- Learning from Others: Partner with data and technology providers to leverage their existing standards and insights.
Reuse Delivers Many Benefits
- Faster Builds and Higher Quality Data Entry: Reusing case report form (CRF) designs and edit checks can lead to faster builds, higher quality data entry, easier reporting, and more efficient cleaning and transformations.
- Resource Efficiency: Reusing CRFs can free up resources to focus on study-specific matters.
Defining Data Standards
- Industry Standards Foundation: Use industry standards like CDISC's CDASH as a foundation to ensure traceability and mapping to end deliverables.
- Segregation and Lean Standards: Segregate standards by therapeutic area and keep them lean, avoiding unnecessary exploratory fields.
- Suggested Templates: Offer suggested templates in addition to formal standards to increase efficiency and flexibility.
Defining eCRF Standards in Practice
- Superset Management: Track and manage eCRF standards at the top level, including versions and specifications.
- Example Specification: An example company's eCRF standard includes detailed specifications for each data element, including variable names, code lists, and instructions.
Establishing Governance, Deviations, and Updates
- Change Control Process: Implement a formal change control process with a governance committee to manage deviations and updates.
- Governance Structure:
- Executive Committee: Maintain corporate commitment and approve new standards and changes.
- Governance Committee: Manage changes and deviations effectively.
By following these guidelines, organizations can successfully establish and maintain robust clinical data collection standards, ensuring efficiency, quality, and compliance.
