The Protocol Template for Definitive/Efficacy (Phase III) Trials
The Protocol Template is an outline of a complete clinical trial protocol, including guidance on important content to include in each section of the protocol. If you have additional questions, once the document has been reviewed, please contact Peter Gilbert. Clinical Research Project Manager, at firstname.lastname@example.org. The template can be downloaded as an MS Word file for adaptation by the study investigator. Download the Protocol Template (Word, 100 kb) Microsoft Word Viewer
Manual of Procedures
The Manual of Procedures (MOP) (PDF, 462kb), is a document used to facilitate consistency in protocol implementation and data collection across patients and clinical sites. Further, the MOP provides reassurance to all participants that scientific integrity and patient safety are closely monitored and increases the likelihood that the results of the study will be scientifically credible.
Clinical Trials Checklist
The purpose of the Clinical Trials Checklist (PDF, 217kb) is to inform NINDS program staff and grantees of the necessary steps and documentation needed for starting a clinical trial.
Clinical Trials.gov Registration and Reporting ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and internationally. It provides patients, family members, health care professionals and members of the public access to information about clinical trials for a wide range of diseases and conditions. Registration in the ClinicalTrials.gov registry works in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.