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Clinical Research: Templates

This guide is designed to be a resource for those conducting clinical research at UF. It includes tabs for resources, training, IRB, Safety and Ethics, NIH, Standards and Templates, and Professional Associations.

Templates

Forms-H application packages must be used for NIH applications with due dates of January 25, 2023 or later

Forms-H changes

NIH

NIH has developed protocol templates for clinical trials, including one for Phase 2 & 3 IND/IDE trials and another for Behavioral and Social Science Research (BSSR) in humans. The templates are available as Word docs or can be used through an e-protocol tool. For more information and links: https://grants.nih.gov/policy/clinical-trials/protocol-template.htm

The National Center for Complementary and Integrative Health, an NIH center, has a protocol template for studies they fund (typically non-pharmacologic): https://nccih.nih.gov/sites/nccam.nih.gov/files/CR-Toolbox/ProtocolTemplate_NCCIH_07-17-2015.docx

In addition, they have a toolkit with links to many other templates relevant to clinical research funded by NIH, such as: case report forms (CRFs), data and safety monitoring, regulatory/essential documents: https://nccih.nih.gov/grants/toolbox

NIH forms table has instructions for, and sometimes templates and samples of, various documents required by NIH (e.g., biosketches): https://grants.nih.gov/grants/forms/all-forms-and-formats.htm

UF

The UF Office of Research has UF-specific forms and templates: http://research.ufl.edu/faculty-and-staff/forms.html

UF Dissemination Plan Language

Data Management and Sharing Plans for NIH-funded studies

NIH Policy for Data Management and Sharing

January 25, 2023, Data Management and Sharing (DMS) policy

Data Management and Sharing Plan (DMSP) format from NIH  (Word doc template for DMSP with instructions)

NIH instructions on writing a DMSP: includes some sample plans

    Many NIH institutes and centers have more specific requirements, in addition to the general DMS Policy

NIH institute and center data sharing policies

    DMS Policy and Privacy

Supplemental information from September 21, 2022: Protecting privacy when sharing human research participant data

Word document with sample Informed Consent language for data to be shared in the National Institute of Mental Health Data Archive (NDA)

  - while this document is specific to NDA, this informed consent language is likely useful researchers planning to share data in other repositories

Additional DMSP writing resources

DMPTool, an online tool for creating DMPs for various funders that comply with their requirements

          Provides templates including a Word and PDF version of NIH-GEN DMSP (Forthcoming 2023)

  - Note their disclaimer: "... researchers should always consult the program officers and policy documents directly for authoritative guidance."

Video tutorial from NNLM on Creating Data Management Plans with DMPTool (Dec 13, 2022)

UF Research Education and Training Program guide to NIH Data Management Sharing Plans and Repositories

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