Conduct
The conduct phase lasts from inclusion of the first participant to closure of the trial database.
Please refer to NorCRIN's website for clinical drug trials.
For clinical drug trials, serious, unexpected, adverse medical events that may be related to the investigational product (SUSARs) should only be reported to the Norwegian Medical Products Agency (DMP), not to the Regional Ethics Committees (REK). Please refer to the SOP Safety Reporting.
Visit the DMP's website for reporting requirements while the study is ongoing (in Norwegian only).
Other serious, unexpected, and adverse events involving research participants must be recorded in the Achilles incident management system as "Patient Events." Incidents related to the use of health data and/or human biological material in research should be recorded in the incident management system as "Other Nonconformities and Improvement Measures." The project manager, project staff, and other personnel are obliged to inform the regulatory authorities of any issues that may pose a risk to the safety of research participants.
Changes to the protocol and other project modifications should follow SOP Modifications After Trial Start..
Correspondence with the DMP/REK, including submissions and decisions, should be sent to godkjenning@ous-hf.no.
The project manager for a clinical trial is responsible for reporting the number of new patients included for each hospital for the previous year. Reporting should take place each spring via an online form. Prior to this, the project manager will receive an email with a personal link to the online form. See Registration and Reporting for more information.