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.
- 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)
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
- 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 5.5 Data handling and record keeping
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