What is it? Why is it important?

Is a printed or electronic tool designed to record from each study participant all information as defined in the study protocol.

The information is made available to the study SP-INV in order to be used during the evaluation or computation of study endpoints.

CRFs exist in paper or in electronic form. In both cases controlled access is restricted to study staff, data confidentiality must be guaranteed and CRF activities must be traceable.

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 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?

  • Modify CRF according to feed-back received from EC
  • Test the correct implementation of the online tool
  • If applicable, upload the randomisation list
  • Distribute access rights according to roles and responsibilities

For more information refer to Documents and Data Handling in this Trial Guide

More

  • Be it electronic or on paper, the SP-INV is responsible for CRF development and implementation. Development can be delegated to the CTU or a CRO. Still, the SP-INV must provide all relevant specifications. Delegated responsibilities are covered in a contract.
  • Check if the developed CRF tool
    • Has secure access (e.g. login and password protected or restricted access to storage folders with respect to paper CRF)
    • Preserves data confidentiality (e.g. the CRF does not include any participant identifiers)
    • For electronic CRFs ensure an audit trail; that tracks data entries made by staff. This includes corrections or changes made on already entered data
  • 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

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
  • CRF – Case Report Form
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • SP-INV – Sponsor-Investigator
Set-Up ↦ 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): Set-Up ↦ Quality and Risk ↦ Case Report Form ↦ Case Report Form

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