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Covid19 actions

Actions taken due to Coronavirus / Covid-19

Protocol change related to changes

• for monitoring

• for shipping / handling of IMP

• of visits or related site of the study participants

• in documentation practice

will be allowed without prior approval from the committee system. However, the committee must be informed as soon as possible of the change, together with a detailed risk assessment. Other protocol changes as a consequence of Covid19 for already approved projects must continue to be submitted to the regional committee that initially approved the project.

New projects as a result of Covid-19 must be submitted to the regional committees. New projects relating to especially complex areas must continue to be submitted to NVK.

Urgent processing from NVK and The Regional Committees has been committed to inquiries and projects related to COVID-19. The committee meeting process could take the form of virtual meetings. Write "COVID-19" in the subject field in the e-mail to komite@rsyd.dk to make sure that the urgent treatment will be initiated. 

For other projects and inquiries, the committees endeavor to comply with normal processing times, provided that the committee members who also perform clinical functions in the hospitals have the opportunity to spend time on the committee work during the Covid-19 situation.

Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
 

The Council of Europe Committee on Bioethics (DH-BIO) has

The Directorate General site of Human Rights and Rule of Law has dedicated

 


Siden er sidst opdateret 20-4-2020
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Region Syddanmark | Damhaven 12 | 7100 Vejle | Email: komite@regionsyddanmark.dk | Tlf: 76 63 10 00