Your Easy Guide to Clinical Studies

Administrative tasks include to:

• Notify the completion, discontinuation, interruption, or resumption of the study to the Ethics Committee (EC) and if applicable regulatory Authorities (RA) (i.e. Swissmedic for risk-category B and C, international authorities)
• Update study registries to inform the public and the scientific community of the completion, discontinuation, or interruption of the study protocol or Clinical Investigation Plan (CIP) (i.e. definition used in Medical Device studies)
• Archive the study for a predetermined period of time (i.e. this can encompass several years). This requires that the protocol/CIP including potential protocol/CIP 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/CIP 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/CIPs

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/CIP 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 – see in particular

• Templates / Notifications / template: "Notification of the completion or discontinuation of the clinical trial or of the research project"

Swissmedic website – see in particular

• Template: End of study notification

Swiss Law

ClinO –  see in particular article

• Art. 38 For the first visit and for completion, premature termination, interruption and resumption of a clinical

ClinO-MD – see in particular articles

• Art. 36 Notification of the completion, premature termination and interruption of a clinical trial
• Art. 37 Final report
• Art. 38 Notification and reporting to Swissmedic

HRO – see in particular articles

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