Planning
The planning phase comprises activities performed until the trial is ready for inclusion of the first participant.
Please refer to the NorCRIN webpage for clinical drug trials, SOP LM2 Planleggingsfasen.
Procedures concerning anchoring and internal approval at OUS, described under Health Research Projects, apply.
Login link for the electronic data collection solution (eCRF) must be provided in the electronic notification form to the Data Protection Officer and the Chief Information Security Officer. The latter assesses whether the solution meets current requirements or whether a Data Protection Impact Assessment (DPIA) must be carried out.
In addition to prior approval from REK, prior approval from SLV is required. NorCRIN SOP LM 2.08 Søknadsprosess, godkjenninger og oppstart (Application Processes, Approvals and Start-up) provides a thorough description of what needs to be done and how.
Correspondence with authorities and ethics committees, including submissions and approvals/decisions, must also be sent to godkjenning@ous-hf.no.
The trial must be registered in EUCTR/ClinicalTrials.gov and at the hospitals' webpages/Helsenorge.no. For registration procedures, see Registration and Reporting.