Your Easy Guide to Clinical Studies

Administrative tasks include to:

• Notify the completion, discontinuation, or interruption of the study protocol to the Ethics Committee (EC) and if applicable regulatory Authorities (RA) (i.e. Swissmedic for risk-category B and C, international)
• Update study registries to inform the public and the scientific community of the completion, discontinuation, or interruption of the study protocol
• Archive the study for a predetermined period of time (i.e. this can encompass several years). This requires that the protocol including potential protocol amendments are archived in such a way as to remain traceable and legible during the entire archiving period
• Document lessons learned. The implementation of a study protocol always includes many challenges. How these challenges are handled during study conduct are important lessons learned. Thus, valuable know can be transferred and mistakes can be prevented when planning future studies and writing future protocols

As a SP-INV:

• Notify the EC/RA regarding the completion, discontinuation, or interruption of your study
• Update study registries applied during the study set-up and conduct phase
• Make yourself familiar with required archiving requirements, and:
  • Write an archiving SOP that defines archiving standards (e.g. access to protected archiving premises, how to ensure documents are protected against theft and destruction such as fire, humidity, and rodents)
  • Ensure the protocol including other archived documents remain legible during the entre archiving period
• Document lessons learned and ensure they remain accessible to be consulted when planning future studies

External Links

Swissethics

Swissmedic website – see in particular

• Template: End of study notification

Swiss Law

ClinO –  see in particular article

• Art. 38 Notification upon study completion, discontinuation or interruption

ClinO-MD – see in particular articles

• Art. 36 Reporting the end, early termination and interruption of a clinical trial
• Art. 38 Notification and reporting to Swissmedic

HRO – see in particular articles

• Art. 22 Notification upon completion or discontinuation of a research project
• Art. 22, 36, 40, 43 Notification of completion or discontinuation of research projects involving biological material and health-related data