What is it? Why is it important?

A case report form (CRF) is a paper or electronic document used by the SP-INV to collect all study protocol required data from study participants.

The eCRF:

  • Uses standardised sheets for data entry
  • Provides local or remote access through personalised login
  • Records all activities in an audit trail (e.g. staff login, time, data entries, changes)
  • Allows for automated data processing (e.g. calculation of BMI based on given weight and height)

Paper CRF:

  • Must be access protected and available only to study staff (e.g. locked closet)
  • Changes are documented directly in the pCRF which must be dated and signed

More

  • The study SP-INV
    • Is responsible for CRF development
    • Decides on variables required to answer the study question
    • Submits the list of selected variables to the EC for approval
  • The paper or electronic CRF must
    • Be strictly based on- and mirror specifications given in the study protocol
    • Function based on requirements given in the law (e.g. audit trail, access control, protected against disclosure and loss)
    • Follow data protection laws (e.g. participants are recorded with individual identifiers instead of participant name or other personal information)

What do I need to do?

  • For your eCRF select an appropriate CDMS (e.g. REDCap, secuTrial)
  • Validate the selected CDMS with respect to your user environment
  • Ensure CRF set-up and content reflect specifications given in the study protocol, (e.g. only data required to answer the study research question(s) are collected)
  • Ensure CRF set-up fulfils regulatory requirements, (e.g. audit trail, access control)
  • Planned data collection requires EC approval, (e.g. provide a list of variables included in the CRF)

For more information refer to Data Handling in this Trial Guide

More

  • Be it electronic or on paper, the SP-INV is responsible for CRF development. Development can be delegated to the CTU or a CRO. Still, the SP-INV must provide all relevant specifications. Delegated responsibilities are named in a contract.
  • Check if the developed CRF tool
    • Guarantees secure access, (e.g. protected login or restricted access to storage folders with respect to paper CRF)
    • Preserves data confidentiality (e.g. the CRF does not include any participant identifiers)
    • Has an audit trail. This allows for all data entries and corrections to be tracked over time
  • The CRF developer should provide a user manual on how to access, use and enter data. This can be very useful to applicable users.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.11 Case Report Form (CRF) definition
  • 5.1 Quality assurance and quality control

Swiss Law

HRO – see in particular article

  • Art. 5 Storage of health related data and biological material

ClinO – see in particular article

  • Art. 18 Storage of health related data and biological material
Abbreviations
  • BMI – Body Mass Index
  • CDMS – Clinical Data Management System
  • CRO – Contract Research Organisation
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – electronic Case
  • pCRF – paper Case Report Form
  • SP-INV – Sponsor-Investigator
Development ↦ Quality and Risk ↦ Case Report Form ↦ Case Report Form
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Quality and Risk ↦ Case Report Form ↦ Case Report Form

Please note: the Easy-GCS tool is currently under construction.