Protocol Templates for Clinical Trials | Grants & Funding - grants.nih.gov
NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research: Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications
US Clinical Development& Medical Affairs-General Medicine AIN457/Secukinumab Clinical Trial Protocol CAIN457FUS01 / NCT02798211 A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of secukinumab 300 mg and 150 mg in adult patients with
ICH M11 guideline, clinical study protocol template and …
Oct 26, 2022 · The ICH M11 Clinical Electronic Structured Harmonised Protocol Template provides comprehensive clinical protocol organization with standardized content with both required and optional components.
Protocol Templates and Guidance - National Institutes of Health
Jul 1, 2024 · There are three templates to be used for observational research: the Natural History/Observational Protocol template, the Repository Protocol template, and the Secondary Research Protocol template.
Clinical Trial Protocol CQAW039A2317 / NCT03226392 A 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthma Document type: Clinical Trial Protocol EUDRACT number: 2017-001272-40
Downloadable Templates and Tools for Clinical Research
Welcome to Global Health Trials' tools and templates library. Please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. Please click on the orange text to download each template.
Protocol Templates - CHOP Research Institute
Jun 15, 2022 · The Study Designs page includes numerous basic journal articles linked to PubMed, introductory books on clinical epidemiology and clinical trials and links to consensus reporting guidelines for clinical trials, observational studies and diagnostic studies.
Clinical Research Study Investigator’s Toolbox
Protocol (MS Word, 93K) - The Clinical Intervention Study Protocol Template outlines a clinical study protocol and provides guidance on important content to include in each section. The template can be downloaded as an MS Word file for adaptation by the study investigator.
Clinical Trials e-Protocol Template/Tool - NIDCD
The clinical trials electronic protocol writing template/tool provides a useful format for NIH-funded Phase II and III clinical trials that are being conducted under an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application.
Clinical Study Tools and Templates - National Institute of …
Jun 20, 2024 · 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 and Drug Administration (FDA) Investigational New Drug (IND) or …
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