Medical Device Clinical Trial Protocol Template

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Protocol Templates for Clinical Trials | grants.nih.gov

https://grants.nih.gov/policy/clinical-trials/protocol-template.htm

Jul 12, 2021

Clinical Research Protocol Template (Device)

https://clinicaltrials.gov/ProvidedDocs/66/NCT03438266/Prot_000.pdf

TEST PRODUCT, DEVICE VOLUME, AND MODE OF ADMINISTRATION: VOLUMA® XC (a hyaluronic acid injectable gel with lidocaine) will be administered via cannula and …

Protocol Templates and Forms - National Institutes of Health

https://ohsrp.nih.gov/confluence/display/ohsrp/Protocol+Templates

Protocol Templates and Forms. This page includes seven different protocol templates for developing a variety of different new research protocols. None of the …

Protocol Templates | CHOP Research Institute

https://www.research.chop.edu/services/protocol-templates

Intervention Study Template (clinical trials): This template is intended to be used for ...

Clinical Trials Guidance Documents | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents

Jan 31, 2023

Clinical Study Templates and Forms - National Institute …

https://www.niams.nih.gov/grants-funding/conducting-clinical-research/trial-policies-guidelines-templates/data-safety-monitoring-guidelines-policies/clinical-study-templates-forms

NIH-FDA Protocol Template for Phase 2 and 3 Clinical Trials. This template aims to facilitate the development of Phase 2 and 3 clinical trial protocols that require a Food …

New Template Guides Protocol Development for Medical Device …

https://cms.centerwatch.com/articles/24578-new-template-guides-protocol-development-for-medical-device-trials-using-rwe

The 38-page template sets out a 12-part framework for building a protocol and provides a set of guiding principles for medical device trial designers, including …

Clinical Device Protocol Template - OUH

https://www.ouh.nhs.uk/researchers/documents/documents/device-protocol.doc

Information on Clinical Device Protocol Template. This protocol template has been designed primarily for Clinical Device Trials which are subject to the Medicines for …

Sample Protocol Template - National Institutes of …

https://www.nhlbi.nih.gov/files/docs/clinical-research-guide-protocol-template.doc

Sample Size Determination and Power. Interim Monitoring and Early Stopping. Analysis Plan. Statistical Methods . Missing Outcome Data. Unblinding Procedures . Data …