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 study data collected during study conduct. CRFs are the basis needed to set-up the study database.


The eCRF:

  • Allows for local and remote access (not at the study site) through personalised logins
  • Records all data entry activities in an audit trail (e.g. date and time of staff login, type 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. participant questionnaires, medical examinations, study inclusion/exclusion criteria)
  • Is reviewed during study monitoring to ensure eCRF entries correspond to original pCRF 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.


A CRF developer (e.g. data manager) should provide a user manual on how to access, use, and enter data. The developer should also be available for questions and support during study conduct


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


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

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Data Handling ↦ Database Development ↦ Case Report Form

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