What is it? Why is it important?

A Case Report Form (CRF), be it paper (pCRF) or electronic (eCRF), is a tool used to document all data (variables) collected during study conduct.

The CRF consists of various standardised sheets for data entry, used by study staff to answer and document study relevant questions (e.g. lab values, scores, ratings). Consequently, the CRF serves as a guide to Site-INV and staff regarding what data to collect at what timepoint.

The eCRF has:

  • Local or remote access through personalised login
  • An audit trail that documents CRF activities (e.g. staff logging into the database, time of data entry, data entered or changed)
  • Automated data processing (e.g. calculation of BMI based on weight and height)
  • An overview of the ongoing status of data collection (e.g. in what study visits are data complete / where is data missing)

Data can be collected on pCRF prior to being entered into the study relevant eCRF (study database).

More

Paper CRFs must:

  • Be access protected and available only to study staff that need the pCRF for the execution of their task (e.g. under lock and key in a closet)
  • Document and ensure that any changes or corrections made in the pCRFs are tracable. This requires that previous entries remain elgible and that the person making corrections dates and signs the document (where changes and new entries were made)

Data collected on pCRF should be monitored for correctness prior to being entered into the eCRF.

A double data entry process might be included to ensure that data was correctly transferred from paper to the electronic CRF form (2 separate staff members enter the same data).

  • The study SP-INV:
    • Decides on variables required to answer the study question
    • Is responsible for the CRF development
    • Submits the CRF to the EC for approval
  • Both pCRF and eCRFs:
    • Are set-up based on specifications given in the study protocol
    • Must have access control, an audit trail, and protection against disclosure or data loss
    • Adhere to data protection laws (e.g. participants must recorded with individual identifiers and not with participant name or other identifying information)

What do I need to do?

  • For your eCRF select an appropriate CDMS (e.g. secuTrial®, REDCap®)
  • Validate the selected CDMS based on your user environment (e.g. in a hospital setting)
  • Ensure CRF set-up and content reflect specifications given in the study protocol
  • Whenever possible, avoid referential and redundant data. Only data needed to answer the study research question should be collected
  • Ensure CRF set-up fulfils regulatory requirements (e.g. audit trail, access control)
  • The CRF must be submitted to EC for approval

More

  • Be it electronic or on paper, the SP-INV is responsible for CRF development
  • Development can be delegated to a CTU or CRO. Still, the SP-INV must provide all relevant specifications and delegated responsibilities must be named in a contract
  • Check if the developed CRF tool is able to:
    • Guarantee secure access with protected logins for eCRFs and pCRF securely stored under lock and key (in a closet)
    • Preserve data confidentiality (e.g. the CRF does not contain any identifiers allowing for the identification of participants)
    • Provide an audit trail. This allows for data entries and corrections to be tracked over time
  • Provide support in the form of a help guide (e.g. system functionality guidelines, data entry guideline)

Where can I get help?

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

External Links

GCDMP – see in particular

  • Chapter “Data Management Plan” – Design and Development of Data Collection Instruments

References

ICH GCP E6(R2) – see in particular guideline

  • 5.5 Data handling and record keeping

Swiss Law

ClinO – see in particular article and annex

  • Art. 5 Rules of Good Clinical Practice
  • Annex 3 Application documents to be submitted to EC

HRO – see in particular article

  • Art. 5 Storage of health-related personal data and biological material
Abbreviations
  • CDMS – Clinical Data Management System
  • CRO – Contract Research Organisation
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • GCDMP – Good Clinical Data Management Practice Guide
  • pCRF – paper Case Report Form
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Data Handling ↦ Study Database ↦ 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 ↦ Data Handling ↦ Study Database ↦ Case Report Form

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