About the Research Registry Toolkit
The Research Registry Toolkit is designed to support teams creating and managing research registries at UNC-Chapel Hill and beyond. The Toolkit includes registry-relevant content about recruitment and engagement, data, and regulatory topics, and focuses solely on registries used for research purposes.
Each section includes examples, best practices, and tools to guide conversations about research registry development and maintenance. The content was designed to be read as a whole or by section.
For the purposes of the Toolkit, a registry is broadly defined as “an organized system that uses observational study method to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves one or more predetermined scientific, clinical or policy purposes”.1
Gliklich RE, Dreyer NA, Leavy MB, eds. Registries for Evaluating Patient Outcomes: A User’s Guide
The Research Registry toolkit was created by the North Carolina Translational and Clinical Sciences (NC TraCS) Institute, the integrated hub of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-Chapel Hill.
In 2017, a team from NC TraCS hosted a large group discussion and twelve key informant interviews with the goal of understanding the needs of researchers working with registries. We learned that there was a need for information about creating registries and addressing challenges when managing registries. Registry study teams were specifically interested in learning more about data quality, REDCap, regulatory issues, and engagement.
Development of the Toolkit was a cross-NC TraCS effort, with the following services contributing: Informatics and Data Science (IDSci); Regulatory; Community and Stakeholder Engagement Program (CaSE); and Trial Innovation Unit. This project was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002489. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
What is a Registry?
Registries and repositories involve the collection and storage of information and/or biological specimens over time, and can serve research, clinical or diagnostic purposes. Research registries, databases, or repositories are created and maintained specifically for research purposes. Many registries serve more than one purpose and can contain both data and specimens. Non‐research registries, databases, or repositories are created and maintained for purposes that are totally unrelated to research. Such purposes may include diagnosis, treatment, billing, marketing, quality control, and public health surveillance. When non-research registries, databases, or repositories are altered to facilitate research (e.g., through the addition of data fields not necessary for the core purpose of the database) they are considered research registries.
Examples of research databases, registries or repositories:
- A list of names, diagnosis, and contact information developed and maintained to identify prospective research subjects
- A collection of medical information and/or biological specimens intended for use in future research studies
- A collection of patients’ diagnosis, treatment, and follow-up information intended for and used to conduct generalizable studies on the effectiveness of particular treatment interventions
The terms database, registry, data bank, repository, and tissue bank are sometimes used interchangeably and often used imprecisely. For the purposes of this toolkit, we will refer to them as research databases, registries, or repositories, and their contents as data or specimens or both.
- Database – A database is a collection of information elements (i.e., data) arranged for ease and speed of search and retrieval. Databases are commonly maintained electronically, but the term can also be applied to paper record systems.
- Research Registry – A registry is a collection of information about individuals, usually focused around a specific diagnosis or condition. Many registries collect information about people who have a specific disease or condition, while others seek participants of varying health status who may be willing to participate in research about a particular disease. Individuals provide information about themselves to these registries on a voluntary basis.
- Repository – A repository is a collection of data or biological specimens from multiple sources. The organizers of the repository maintain the data or specimens over time and control access to and use of data or specimens. Data or specimens are used by multiple individuals and/or for multiple purposes that may evolve over time.