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.
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:
© 2013 Mayo Foundation for Medical Education and Research. All rights reserved.