Policies and Guidance Documents
Distributed Research Network
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.
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.
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 Working Groups and Cores 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 Cores/Working Groups and Demonstration Projects.
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.
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.
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.