Your Easy Guide to Clinical Studies

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

 

Substantial amendments require:

• An initial protocol revision followed by an approval by the EC if applicable RA (e.g. Swissmedic)
• Applicable adaptations to the study database (eCRF)
• Validation, approval and release of the newly adapted database

As a SP-INV and in collaboration with the study Data Manager (DMan) and Statistician, evaluate the impact of an amendment on:

• 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

External Links

Swissethics – search in particular

• Definition of substantial and non-substantial amendments

References

ICH GCP E6(R2) – see in particular guidelines

• 4.5 Compliance with the protocok
• 5.5. Trial Management, data handling, and record-keeping