NorTrials Launches New Service for Quality Assurance of Information and Consent forms

The implementation of the Clinical Trial Regulation EU No 536/2014 means that the role of the national coordinating investigator (NCI) for clinical trials is no longer required. One of NCI's tasks has been to ensure the quality of study information and consents forms in accordance with applications to national authorities. This task and responsibility has now been delegated to the sponsor.

Checklist for patient information and consent sheet for participation in clinical trials

The NorTrials coordinating unit has developed the following checklist, which we
recommend reviewing before submitting the information document and consent
form to the Regional Ethical Committee for Clinical Trials of Medicinal Products and
Medical Devices (REK KULMU).

See checklist

NorTrials' coordinating unit now offers a service to assist industry sponsors in reviewing and ensuring the quality of study information before submission to authorities. This is to reduce the number of comments related to the informed consent form during application processing by the Regional Committee for Medical and Health Research Ethics for Clinical Trials of Medicinal Products and Medical Devices (REK KULMU).

The service is free and carried out by advisors at NorTrials coordinating unit.

The offer includes:

General language editing
Review in accordance with the REK template (Template for study information for drug trials)

This is in accordance with ICH-GCP and the national SOP for preparing written information and consent declarations.

If necessary, the NorTrials coordinating unit has the ability to obtain medical expertise through the NorTrials centers to professionally review the content.

To provide this service, we need from the sponsor:

Original information sheet (s) (if in a language other than Norwegian)
Draft of Norwegian information sheet(s)

The processing time is estimated to 5 working days after receiving the documents.

Note that the estimated time for review is dependent on the complexity and the number of ICFs.