Module 15 Presentations

10/04/2024

MHRA submissions:

How to apply 1. Notify the MHRA via e-mail of your intention to conduct the study. 2. Applications must be made via the Integrated Research Application System (IRAS). 3. Complete the MHRA Clinical Investigation Application form on IRAS and upload the relevant supporting documents, submit. 4. The 60 day assessment period will commence once a valid notification is received by the MHRA. 5. All information must be in English.

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Ethical Approval in UK

Should be submitted at the same time as the MHRA application.

How to apply: 1. Applications must be made via the Integrated Research Application System (IRAS). 2. Complete the HRA/EC Clinical Investigation Application form on IRAS and upload the relevant supporting documents 3. Call up the Central Booking Service (CBS) submit or use their online service. 4. The REC will issue a validation letter within 5 working days, to confirm the application is valid. 5. The REC have a requirement to provide an ethical opinion on an application within 30 calendar days (14 days after the meeting)

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