NORWAY: NoMA allows changes and safety measures in clinical research prior to approval during COVID-19 emergency
Norwegian Medicine Agency (NoMA) guided many aspects of clinical research in response to COVID-19 emergency.
Meditrial manages several studies in Norway and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
Any safety measure can be immediately implemented and notified for approval at a later date by email.
The use of telemedicine can be undertaken by sponsors if medically justifiable concerning further treatment of the patients.
Any changes regarding patient consent, patient information, the use of remote or electronic information, forms for recruitment must be reviewed by an Ethics Committee.
Monitoring activity change
Sponsors are allowed to implement centralised monitoring based on data reported in electronic Case Report Forms (eCRFs). Although remote Source Data Verification (SVD) is forbidden due to data protection.
Contact for any further info request:
Tel: +47 22 89 77 00
email: klut@noma.no
For email requests, it is recommended to include “Covid-19” in the subject. Delays in response might occur due to staff reduction.
A fast-track processing applies to all studies for treatment/prevention of COVID-19.
For more details, please visit the website.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
