Post-Review/Pre-Funding
- 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. The template can be downloaded
as an MS Word file for adaptation by the study investigator ...more
- Manual of Procedures The Manual of Procedures (MOP) 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 ...more
- Clinical Trials Checklist
The purpose of this checklist is to inform NINDS program staff and grantees of the necessary steps and documentation needed
for starting a clinical trial.
[MS Word Version] [PDF Version]
- Gender/Minority Information
- Required registration to ClinicalTrials.gov ClinicalTrials.gov is a consumer-friendly database with information on more than
13, 500 clinical studies sponsored by the National Institutes of Health (NIH), other federal agencies, and private industry.
The NLM and the ICJM have agreed that any clinical trial that is not registed on ClinicalTrials.gov prior to the first patient
enrolled will not be allowed to publish study results in any ICJM journals. more...
- Conversion to Cooperative Agreement
- Certificate of Confidentiality
- Budget Template
- Monitoring Guidelines
- Promoting Objectivity Avoiding Conflict of Interest
- NIH Data Sharing
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Last updated December 30, 2008
