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
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)
Data Management and Sharing Plan information from NSF
Includes NSF's data sharing policy, general guidance, and directorate/division-specific information
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