What is it? Why is it important?
Amendments are changes to the study protocol during study conduct. Amendments cane either be substantial or non-substantial. Changes impacting the collection of study data are generally substantial amendments (e.g. the inclusion of additional study site(s) or data).
Examples of amendments that affect data collection
- New scientific evidence becomes available that require an adaptation regarding study aim, safety concerns, data collection and statistical study plan
- The collected data is shown to be inadequate to answer the study question. The collection of additional data (e.g. variables) becomes necessary (e.g. additional blood samples, medical tests, participant feedback)
- Total number of study participants needs to be increased. In order to gain access and recruit adequate participants the inclusion of additional study-site(s) becomes necessary
What do I need to do?
- Currently existing study data (eCRF, pCRF), randomisation processes, data analysis and evaluation
- Documentation requirements regarding. This will increase when adding a new study-site (e.g. confidentiality, restricted access, data import, staff responsibilities and staff trainings)
- Potential risks to data quality and participant safety
- Participant recruitment and potentially having participants re-consent to study participation (e.g. signing of an amended ICF)
Implement an amendment:
- In collaboration with the DMan
- Only once EC if applicable RA (e.g. Swissmedic) approval has been received
- Establish and save the database as a new updated version
- Validate the amended database and ensure it works as intended
- Train staff on applicable changes
- Upon successful validation and training release the amended database for data entry
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
Swissethics – search in particular
- Definition of substantial and non-substantial amendments
ICH GCP E6(R2) – see in particular guidelines
- 5.5. Trial Management, data handling, and record-keeping