Project identification Project name/description Principal Investigator Representative of person or entity responsible for research Identification in continuous record of project activities Information about the trial subject Trial subject's ID in the project Trial subject's age Trial subject's gender Date of inclusion in the project Information about the adverse event Event started on date Event first reported date Event reported to/observed by date Event ended on date Description of the event □ □ Is the event unexpected? Yes No □ □ Yes No Is the event serious? □ □ Yes No Is the event assumed to be related to the research? □ □ Has the event been reported to the Norwegian Board of Health? Yes No Date of report ________________________ dd.mm.yyyy Principal Investigator’s signature
Project identification Project name/description Principal Investigator Representative of person or entity responsible for research Identification in continuous record of project activities Information about the trial subject Trial subject's ID in the project Trial subject's age Trial subject's gender Date of inclusion in the project Information about the adverse event Event started on date Event first reported date Event reported to/observed by date Event ended on date Description of the event Is the event unexpected? Yes □ No □ Is the event serious? Yes □ No □ Is the event assumed to be related to the research? Yes □ No □ Has the event been reported to the Norwegian Board of Health? Yes □ No □ Date of report ________________________ dd.mm.yyyy Principal Investigator’s signature
2.6.-form-for-reporting-adverse-event.docx