Choosing the Right Tool
Investigators involved in clinical research require mechanisms for collecting and managing their data. For years, many investigators at Mayo Clinic (and many other institutions) have built their own systems for data management, or used other database tools, including Microsoft Excel or Access. Building a custom data management system for each study is time consuming, expensive and a needless duplication of effort. The use of dozens of unique data management systems hampers the effort to integrate appropriate systems within Research and Mayo Clinic, which is a frequent request from investigators and study teams. Such practices also put investigators at risk for loss of data if they experience a system crash or a change in study personnel.
To support the creation of a coordinated and comprehensive research management system, Mayo Clinic has designated three institutionally-supported data management systems: REDCap, SDMS and CTMS/Rave. These systems were chosen to offer a wide range of services for clinical trials and studies at all levels of complexity and scale.
Use of one of the three institutionally supported data management tools at Mayo Clinic is strongly recommended, as "homegrown" databases will not be integrated with other functions. All future research integration efforts will focus on connecting these three platforms with other Research and institutional systems, such as IRBe, MIRIS, RLIMS, and Lawson/Business Objects.
Tier 1: REDCap
Low to medium complexity, little or no cost
REDCap is appropriate for studies with low to medium data collection complexity. It supports single or multi-site studies, and is available through the Center for Translational Science Activities (CTSA) and the Department of Health Sciences Research (HSR). Use of REDCap incurs no direct cost for investigators, unless HSR builds and configures the study for investigators. Investigators currently managing their data in Microsoft Excel or Access will find REDCap an excellent replacement.
Read more about REDCap
Tier 2: SDMS
Medium to complex studies, moderate cost
Study Data Management System (SDMS) is appropriate for studies with a range of data collection complexity. SDMS offers connectivity to a host of electronic data sources at Mayo, allowing for the pre-population of data elements. This makes it an ideal choice for many retrospective studies. It is offered by the Department of Health Sciences Research (HSR), and incurs a moderate cost to investigators. SDMS provides automatic data security and access log compliance for every hosted project, as well as standardized methods for data validation. It allows autonomous project setup, creation, and maintenance, and provides a simple, agile platform, allowing web developers to focus on project functionality.
Read more about SDMS (Requires that you be logged in to the Mayo network)
Tier 3: Medidata Rave
For most types of clinical research, especially large, complex or multi-site studies, moderate cost
Medidata Rave, implemented via the Clinical Trials Management Systems (CTMS) project in 2010, provides Mayo Clinic with new, strategic-level capabilities in both electronic data capture and clinical data management. Its scalable architecture provides regulatory compliance, sophisticated complex data management and quality control. CTMS/Rave also brings a powerful multi-site collaboration capability for clinical trials and other types of clinical research. CTMS/Rave is fully 21 CFR Part 11 compliant, making it the ideal solution for FDA governed clinical trials.
The National Cancer Institute (NCI) supports Mayo Clinic's use of Rave for NCI-funded research studies and clinical trials. Enterprise-wide adoption for all types of clinical research places Mayo Clinic far ahead of most academic medical centers, assuring Mayo's leadership as a coordination site for research consortia and industry-sponsored, multi-site trials.
Read more about Medidata Rave