UK MHRA: Notify MHRA About a Clinical Investigation for a Medical Device
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device
USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations
UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device
Swiss Medic: Information sheet on Clinical Investigations with Medical Devices
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
USFDA Guidance: Methods to Identify What Is Important to Patients
MDCG offers Guidance on Clinical Investigations – Europe