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Things You Need To Know Now That You Will Be Funded



Budget Template
This template may be used for each clinical site, in addition to this template, information required under the funding mechanism of choice should be provided. This template is intended to be used to help the principal investigator, clinical site investigators, program staff, and reviewers better understand how funds will be distributed overall, within and between clinical sites, and throughout the duration of the trial. more...

Certificate of Confidentiality
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. more...

Checklist for Clinical Trials. 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]

ClinicalTrials.gov Registration
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 registered on ClinicalTrials.gov prior to the first patient enrolled will not be allowed to publish study results in any ICJM journals. more...

Conflict of Interest and Promoting Objectivity
NIH takes financial conflicts of interest very seriously. As you plan, avoid conflicts of interest or the appearance of a conflict stemming from your financial relationships. more...

Cooperative Agreement Conversion
All NINDS grantees intending to conduct clinical research (all research involving human participants) should be aware that before an award is made, NINDS will routinely consider the necessity of substantial program staff technical involvement or participation in programmatic activities of the award. more...

Gender/Minority Information
Inclusion of Women and Minorities as Participants in Research Involving Human Subjects 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

Monitoring Guidelines. NINDS is responsible for monitoring in clinical research it supports. Data and safety monitoring of a clinical trial is commensurate with the risks posed to the study participants with the size and complexity of the study. ...more

NIH Data Sharing. Data sharing is essential for expedited translation of research results into knowledge, products and procedures to improve human health. This page provides information on NIH data sharing policies. ...more

NINDS Common Data Elements: A repository and dissemination tool for all NINDS CDEs for Investigators to utilize for trials being planned, and ongoing research. ...more

Protocol Template (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

Quality Assistance and Assurance Visit

  • Data Quality Checklist for NINDS Investigators to Conduct a High-Quality Research Project
    [MS Word Version] [PDF Version]
  • NINDS Glossary of Clinical Research Terms

Quality Assurance Guidelines. The purpose of these Guidelines is to assist investigators in developing and implementing quality assurance (QA) procedures that can be integrated into their clinical research projects. The objectives of QA procedures are to assure the accuracy and consistency of study data, from the original observations through the reporting of results and to ensure that study results are considered valid and credible within the scientific and clinical communities. ...more

Quarterly Progress Report. A quarterly report is required during the start-up and recruitment and enrollment of participants stages of a multisite clinical research project that exceeds $1M direct cost in any given funding period. The NINDS may request this report for complex multisite studies in which funding does not exceed $1M, this will be decided on a case-by-case basis.
[MS Word Version] [PDF Version]

Recruitment and Retention Resources. The purpose of these resources is to assist investigators in planning their recruitment and retention strategies, including guidelines and policies for central monitoring of site activation and study accrual. ...more

Terms of Award. These Terms of Award are in addition to and not in lieu of other NIH grant administration policies, such as written assurance of compliance with the Office of Human Research Protections regulations (45 CFR 46), PHS guidelines, HHS grant administration regulations (45 CFR parts 74 and 92), and Office of Management and Budget administrative guidelines. ...more

Start Up Meeting information. The Office of Clinical Research staff holds pre-award start up meetings for grantees funded to conduct Phase III and multi-site Phase II trial. Study team members (PI and Co-I, coordinator, statistician and business office official) are asked to attend a one day meeting in Rockville, Maryland. As you plan your application, consider including time and costs for this meeting. ...more











Last updated July 29, 2014