Policies and Guidance Documents

Policies and Guidance Documents

​Distributed Research Network

Distributed Research Network Governance Policy and Procedures

Provides an overview of the NIH Collaboratory’s Distributed Research Network (DRN) governance policies, querying capabilities, and responsibilities. The policies and procedures were developed by the NIH DRN Governance Advisory Committee and approved by the Collaboratory Steering Committee and others as directed by the Collaboratory Coordinating Center housed at the Duke Clinical Research Institute (DCRI). These policies apply to NIH DRN activities, providing guidance on collaboration in the use of electronic health data, while also safeguarding protected health information and proprietary data.

Data Sharing

Data Sharing Considerations

Sharing research data collected in the NIH Collaboratory’s pragmatic trials is essential to several core objectives of the Collaboratory program, including maximizing the public health impact of the significant NIH investment in these large projects; accelerating the pace of learning throughout the US healthcare system; and increasing participation in research and learning by a wide range of stakeholders, including healthcare systems, healthcare providers, and patients/consumers. This document describes various considerations such as the use of healthcare system data, methods and tools for data sharing, and expectations for Collaboratory trials.

Data Sharing Policy
The NIH Collaboratory Steering Committee agrees that data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data. This document states the four policies adopted by the Collaboratory for data sharing.

NIH Collaboratory Products and Publications

Defines the various types of publications, manuscripts, and presentations designated as Collaboratory publications. It also delineates the procedures to be followed by Core Working Groups when submitting publications to the C3PC (Collaboratory Products, Publications & Presentations Committee) regarding content, authorship, and approval. Also described are procedures for Demonstration Projects.

  • A Publications Process Handout is also available describing the process to follow for Collaboratory publications, both from Core Working Groups and Demonstration Projects.
Collaboratory Copyright Policy

All original content created for and published by the NIH Collaboratory, including the NIH Collaboratory website, the Knowledge Repository, and Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials will be made freely available, without restrictions. Note that this policy does not apply to material published by other parties, such as peer-reviewed manuscripts published in scientific journals.

Living Textbook Publication Agreement

Contains details about the publication agreement between the Collaboratory and authors of materials created for publication in Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials.

Collaboratory Products

Describes the applicable review and approval procedures for various products produced by Collaboratory members, including guidance documents, best practices documents, short communications, and tools.

Data Quality Guidance

Data quality assessments are the only way to demonstrate that data quality is sufficient to support the research conclusions, and such assessment results must be accessible to consumers of research. This white paper describes in detail the dimensions of assessing data quality for healthcare system use and provides assessment recommendations for Collaboratory Demonstration Projects.

An abbreviated version of the white paper, Assessing Data Quality of Clinical Data for PCTs, describes data quality dimensions and recommendations for assessments.


Policies and Guidance Documents: Policies and Guidance Documents. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/nih-collaboratory-policies-and-guidance-documents/. Updated April 3, 2019.