Designing Smarter CRFs: Tips from our Clinical Study Builds

Clinical trials are only as strong as the data they collect. At Touchcore Systems, we've supported over 100 clinical study builds across therapeutic areas and phases. A consistent lesson from our experience is this: Case Report Form (CRF) design plays a pivotal role in reducing query rates, accelerating database locks, and ensuring protocol compliance.

Here are our top insights for designing smarter CRFs that streamline clinical trials from day one.

1. Start with the Protocol, Not the Platform

CRF design should mirror the protocol, not the EDC system’s default structure. Before opening your form builder, align your CRF fields with:

• Primary and secondary endpoints

• Visit schedule and assessments

• Inclusion/exclusion criteria

This approach ensures that every field supports a clear data collection purpose tied to regulatory and scientific requirements.

2. Design for the User: The CRC

Clinical Research Coordinators (CRCs) are your primary form users. Smart CRF design prioritizes usability:

• Group fields logically (e.g., vitals, labs, ECGs).

• Keep screen lengths manageable—no endless scrolling.

• Use clear, intuitive field labels (avoid jargon).

• Employ dynamic forms to show/hide sections based on relevant criteria.

Reducing CRC friction leads to more complete, accurate data entry—and fewer downstream queries.

3. Build-In Compliance and Quality Checks Early

Validation rules shouldn’t just catch errors—they should guide correct data entry:

• Use range checks and format constraints for critical fields.

• Add conditional logic to prevent protocol deviations (e.g., date checks ensuring visit windows).

• Implement auto-population where appropriate to reduce redundancy and inconsistency.

The key is balancing automation with flexibility—excessive hard stops frustrate users.

4. Standardize Where Possible, Customize Where Needed

Libraries of standardized forms (labs, vitals, demographics) help speed builds and ensure consistency across studies. But every protocol has its nuances. Effective CRF design:

• Leverages CDASH/CDISC standards for core domains.

• Allows customization for protocol-specific elements, such as novel endpoints or device integration.

A hybrid approach supports scalability while honoring scientific uniqueness.

5. Plan for the Endgame: Lock and Submission

Think beyond study startup:

• Are data exports aligned with analysis plans?

• Are your forms structured to support SDTM conversion?

• Are the audit trails and electronic signatures aligned with 21 CFR Part 11 compliance?

Smarter CRFs reduce reconciliation headaches during database lock and submission prep.

6. Engage Cross-Functional Stakeholders Early

The best CRF builds are never done in silos. Bring in:

• Clinical Ops (for feasibility and workflow insights)

• Biostatistics (to confirm endpoint alignment)

• Medical Monitors (for safety data expectations)

Early collaboration ensures forms are not only compliant but also fit-for-purpose across the trial lifecycle.

Final Thoughts: Smarter Forms, Smarter Trials

At Touchcore Systems, our deep involvement in clinical data operations has shown us how smarter CRF design is a strategic enabler—not just a technical task. Whether you're running a first-in-human study or a global Phase III trial, optimized CRFs can be the difference between costly delays and a smooth, efficient path to database lock.

Want to rethink your CRF strategy? We’d love to share more insights from the field and explore how our team can support your next study build.