General Guidelines

Inside the NIH Grant Review Process

Human Subjects in Research

NIH Data Sharing Policy

NIH Forms and Applications

NIH Grants Policy Statement (Rev. 03/01): Corrections and Clarifications (NOT-OD-01-026)

The NIH Grants Process: the Big Picture

NIH Standard Receipt Deadlines

Publication of the Revised National Institutes of Health Grants Policy Statement (NOT-OD-01-015)

Use of Animals in Research

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Clinical Research Guidelines

Rigor & Reproducibility

Improving the Quality of NINDS-Supported Preclinical and Clinical Research (PDF, 84kb)

NIH Modular Research Grant Applications

NIH Policy of Reporting Race and Ethnicity Data: Subjects in Clinical Research

Approval Process for the Documentation of Compliance With NIH Guidelines on the Use of Human Pluripotent Stem Cells in NIH Research Proposed for Support Under Grants and Cooperative Agreements (NOT-OD-01-003 amended)

Recruitment and Retention Plans to Enhance Diversity

Quality Assurance Guidelines

NINDS Common Data Elements

NINDS Enrollment Planning and Monitoring System (PDF, 191kb)

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, 61kb)

Incremental Funding of Large Multicenter Studies

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Translational Research

Translational Research Decision Tree

CounterACT Program

CounterACT Application Assistance Webinar

CounterACT Examples (U01 and U54): Milestones

CounterACT Frequently Asked Questions

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

CREATE Bio Example: Target Product Profile (TPP)

CREATE Bio Webinars

CREATE Bio Program FAQs

CREATE Bio Program Pre-Application Process & Background

IGNITE Program

IGNITE - Definitions for Key Terms

IGNITE Example: Milestones

IGNITE Webinar Slides (pdf, 448 kb) - December 2018

Webinar Q&A Transcript
 

 

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Forms and Tools

ClinicalTrials.gov Registration

Enrollment of Subjects into Clinical Trials - Information Requested on Participant Availability at Clinical Sites (PDF, 42kb)

Guidelines for Developing a Manual of Procedures (MOP) (PDF, 468kb)

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, 458kb)

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, 79kb)