Policies and Guidance Documents

Policies and Guidance Documents

​Distributed Research Network

Distributed Research Network Policies and Procedures

Provides an overview of the NIH Pragmatic Trials Collaboratory’s Distributed Research Network (DRN) governance policies, querying capabilities, and responsibilities. The policies and procedures were developed by the DRN Governance Advisory Committee and approved by the Steering Committee and others as directed by the Coordinating Center at the Duke Clinical Research Institute (DCRI). These policies apply to 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 Trials is essential to several core objectives of the 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 the NIH Collaboratory Trials.

Data Sharing Policy
The NIH Pragmatic Trials 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 4 policies adopted by the NIH Pragmatic Trials Collaboratory for data sharing.

Publications, Presentations, and Products

Defines the various types of manuscripts, abstracts, presentations, and other products derived from NIH Pragmatic Trials Collaboratory–funded activities. It also delineates the procedures to be followed by Core Working Groups when submitting publications to the Publications, Presentations, and Products Committee regarding content, authorship, and approval. Also described are procedures for NIH Collaboratory Trials.

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

All original content created for and published by the NIH Pragmatic Trials Collaboratory, including the 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 NIH Pragmatic Trials Collaboratory and authors of materials created for publication in Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials.

Data Quality Guidance

Assessing Fitness for Use of Real-Word data

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. A given dataset may be well suited to answer a research question for a specific patient population over a certain time period, but not suitable for a different population or time frame. This chapter describes several approaches that can be used to facilitate assessments to determine whether real-world data are fit for their intended use prior to their use in research settings.

This guidance builds upon an earlier NIH Collaboratory Assessing Data Quality white paper (Zozus et al. 2014), which described in detail the dimensions of assessing data quality for healthcare system use.

Citation:

Policies and Guidance Documents: Policies and Guidance Documents. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/nih-collaboratory-policies-and-guidance-documents/. Updated February 5, 2024.