Clinical Research Data Management Guide

News

Developments that affect clinical research data management — funding and policy, regulation, standards, workforce, research, philanthropy, and technology. We summarize what changed and why it matters, link to the original source, and stay analytical rather than partisan: our editorial policy explains how we cover policy and funding news.

Funding & Policy National Institutes of Health · January 25, 2023 · National (U.S.)

NIH Data Management and Sharing Policy now applies to all NIH-funded research generating scientific data (external link to National Institutes of Health)

NIH's Data Management and Sharing (DMS) Policy took effect January 25, 2023, replacing the 2003 data sharing policy. Applications for research expected to generate scientific data must include a DMS plan covering data types, standards, repositories, timelines, and access and reuse considerations — regardless of budget size, unlike the prior policy's $500,000 threshold. Compliance with the approved plan is a term and condition of the award, and reasonable data management and sharing costs may be budgeted.

Why it matters

For NIH-funded teams, data management planning is now a condition of funding rather than a good habit. The plan written at application time constrains repository choice, standards, de-identification, and retention for the life of the study — so the people who will actually run the study database should help write it, and curation and sharing costs should be claimed in the budget rather than silently absorbed.

Federal agency policy · Topics: NIH, data sharing, data management plans, grant policy · Checked September 1, 2026 · Read the original at National Institutes of Health (external link)

We summarize and link — we do not republish. Statistics are taken from the linked source, read before summarizing, with the date we checked shown on each item. Corrections follow our editorial policy.