General Guidelines
Clinical Research Guidelines
Improving the Quality of NINDS-Supported Preclinical and Clinical Research(pdf, 85 KB)
NIH Modular Research Grant Applications
NIH Policy of Reporting Race and Ethnicity Data: Subjects in Clinical Research
Recruitment and Retention Plans to Enhance Diversity
NINDS Enrollment Planning and Monitoring System(pdf, 498 KB)
PHS 398 Grant Application Requirements
NINDS Policy for Submission of Applications Containing Clinical Trials
Policy for the Award and Continuation of Investigator-Initiated Phase III Clinical Trials
NINDS/NIH Policies for Monitoring Clinical Research
NINDS Guidelines for Data and Safety Monitoring in Clinical Trials
NINDS Data and Safety Monitoring Board Conflict of Interest and Confidentiality Statement(pdf, 62 KB)
Translational Research
Translational Research Decision Tree
CounterACT Program
CREATE Bio Program
CREATE Bio: Compare Discovery & Development Tracks
CREATE Bio Example: Antibody Agent Profile Table
CREATE Bio Example: Anti-sense-oligonucleotides Agent Profile Table
CREATE Bio Example: Cell Therapy Product Profile FAQ Reference
CREATE Bio Example: Gene Therapy Agent Profile Table/Reference
CREATE Bio Example: Milestones
CREATE Bio Example: Peptides or Protein Agent Profile Table
CREATE Bio Example: Sample Timeline
IGNITE Program
IGNITE - Definitions for Key Terms
IGNITE Webinar Slides(pdf, 460 KB)(pdf, 460 KB) - December 2018
Forms and Tools
ClinicalTrials.gov Registration
Guidelines for Developing a Manual of Procedures (MOP)(pdf, 467 KB)
NIH Neurological and Behavioral Function Measures (NIH Toolbox)
NIH Neurological Self-Report Quality of Life Measures (NeuroQOL)
NIH Patient Reported Outcome Measurement Instrument System (PROMIS)
NINDS's Building Up the Nerve: NINDS’s podcast, Building Up the Nerve, provides an introduction to the grant cycle from NINDS staff
Privacy Protection for Research Subjects: Certificates of Confidentiality
PHS 398 Grant Application Requirements
Protocol Template (Phase III Trials) (MS Word, 100kb) Microsoft Word Mobile If you have additional questions, once the document has been reviewed, please contact Peter Gilbert.
Quality Assurance & Assistance Checklist for Clinical Trials(pdf, 469 KB)
Recruitment and Retention Planning: Getting Started
Sample Data Sharing Consent Language (MS Word, 59kb) If you are having trouble accessing the Sample Data Sharing Consent Language form above, please email Sara Rue.
Supplemental Information Data Template(pdf, 81 KB)