Ancillary Studies

• Proposals (password required)

• Calendar of Conference Calls with Study Proposal Due Dates

• Study Proposal Form (revised 11 Sep 2023) (Word) (PDF)

• NASH CRN Ancillary Studies Policy (revised September 2023) (Word)

• Ancillary Studies Policy Appendices

  • List of NASH CRN Steering Committee liaisons

  • Process to obtain samples from the NIDDK Biorepository is in flux at the NIDDK Central Repository (as of Feb21)

  • NASH CRN Biomarker Proposal Guidelines

  • NASH CRN Collaborative Partner Agreement template

  • NIDDK Central Repositories Specimen and Data Use Certification - Appendix A is now completed on the NIDDK website (as of Feb21)

  • Cost of retrieving serum, plasma, liver tissue, and DNA from the NIDDK Central Repositories

  • NASH CRN Data Use Assurance Protection agreement

  • NASH CRN Global Data Dictionary (as of July 2017)

• Funding Opportunities

  • PA-20-185: R01 Research Project Grant - Ancillary Studies to Major Ongoing Clinical  Studies

• Helpful infographics on Exemptions for Human Research:

  • Human Subject Regulations Decision Charts: 2018 Requirements

  • Exempt Human Subjects Research: 8 Excemptions Infographic (15Jan2020)D

• Genome-wide Association Studies

  • Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)

• Biomarker Studies

  • Biomarker Advisory Committee members

  • Requirements for Biomarker Study proposals

    • Template Collaboration Agreement

  • TRIPOD Statement

  • FDA Guidance on Biomarker Development

    • Biomarker Identification: Evidentiary Framework (Dec18)

    • Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (13Mar07)

    • Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification (May16)

• NASH CRN Pilot and Feasibility Study Policy

• Types of studies (definitions)

• For NASH CRN Investigators only (password required)

  • Proposals

  • Conference calls

  • Liver Tissue Processing

  • Biosample information:

    • NIDDK Cost Recovery Notice (14Jan16)

    • Biospecimen Requests: Steps taken to request fulfillment: This will be updated once the NIDDK Central Repository finalizes the procedure (as of 17Mar21).

    • Biosample and Digital Repository Inventories

    • RFP: Proposal to receive and process DNA

 Last updated:  10 December 2023