Accurate, reliable, usable data — it's the lifeblood of clinical research. The method an investigator chooses for collecting, storing and analyzing data can mean the difference between a study that advances the science and improves patient care, or a study with inconclusive results and no publications.
In order to maximize investigators’ efforts to effectively collect, store, retrieve and analyze their data, Mayo Clinic has streamlined its supported electronic data capture and data management systems into three tiers/products.
Need help choosing?
If you need help with your data management strategy, visit Choosing The Right Tool to compare data management tools.
Tier 1: REDCap — appropriate for studies with low to medium data collection complexity, including an effective survey creation and management tool. REDCap is not 21 CFR Part 11-compliant.
Tier 2: SDMS (Requires that you be logged in to the Mayo network) — ideal for moderately complex studies, including retrospective studies, which can benefit from its interface options for pre-population of data elements. SDMS is not 21 CFR Part 11-compliant.
Tier 3: CTMS/Medidata Rave — provides regulatory compliance, sophisticated data management and quality control, and the ability to manage multi-site trials and clinical research. CTMS is fully 21 CFR Part 11-compliant.
Benefits of standardized data management
Using one of the three tiers of standardized data management tools that Mayo Clinic supports provides several benefits for investigators and the institution:
- Save time and expense for study design and setup
- Increase efficiency of data collection, lock down (validation) and analysis, shortening time from study completion to reporting and publication
- Reduce administrative burden on investigators and study teams, creating increased capacity for research projects
- Facilitate integration with other institutional tools, such as IRBe and MIRIS, by limiting the number of supported platforms that must be reconciled