What is it? Why is it important?

A Case Report Form (CRF) is a paper (pCRF) or electronic (eCRF) standardised document used by the SP-INV to document data collected during study conduct. CRFs are the basis needed to set-up the study database.

 

The eCRF:

  • Allows for the local and remote access (not at the study site) through personal logins
  • Records all data entry activities in an audit-trail (e.g. date and time of staff login, value of data entered, implemented changes)
  • Allows for automated data processing (e.g. calculation of BMI based on weight and height)
  • Provides an overview of ongoing data collection during study conduct (e.g. completed visits / currently missing data)

 

The pCRF:                          

  • Is used to collect data from study participants (e.g. questionnaires, medical examinations, eligibility criteria ( e.g. study inclusion/exclusion)
  • Is reviewed during study monitoring to ensure it corresponds eCRF entries 

What do I need to do?

As a SP-INV:

  • Design the study CRF based on the planned study and its required data (variablers)
  • Ensure CRF content only includes variables specified in your study protocol
  • Ensure the CRF complies with regulatory requirements (e.g. audit-trail, access protected (pCRF), and access control (eCRF), protection against disclosure and data loss)
  • Guarantee data confidentiality (e.g. data protection law). Participant identifiers (e.g. name, DOB) are not entered in the CRF, but they are provided individual ID-codes. Plan to keep a separate participant identification-log
  • Set-up data entry requirements based on ALCOA+ guidelines
  • Submit the CRF to Ethics Committee (EC) for approval

 

CRF responsibilities can be delegated to a data manger, study staff, or CRO (e.g. document responsibilities in a staff delegation-log or in a partner contract). Final responsibility remains with the SP-INV.

More

ALCOA+ guidelines state that data must be:

  • Attributable: ability to retrace when (date and time), and who made a data entry
  • Legible: changes or corrections to entries are legible. Corrected entries are be obscured
  • Contemporaneous: current
  • Original: not faked, documented by the attributable person
  • Accurate: correct
  • Complete: no missing data
  • Consistent:
  • Enduring: cannot be deleted
  • Available: data is accessible to relevant persons (e.g. study staff, monitor)

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 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
  • ClinO – Clinical Trials Ordinance
  • CRO – Contract Research Organisation
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • DOB – Date of Birth
  • EC – Ethics Committee
  • HRO- Human Research Ordinance
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SP-INV – Sponsor-Investigator
Development ↦ Data Management ↦ Database Development ↦ Case Report Form
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Data Management ↦ Database Development ↦ Case Report Form

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