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.
- The study SP-INV
- 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
- 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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
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