Text and Data Mining valid from 2019-06-24
Received: 12 November 2017
Accepted: 10 June 2019
First Online: 24 June 2019
Ethics approval and consent to participate
: A study protocol, an institutional review board exemption determination (Quorum IRB exemption determination #31309), and a data use agreement were required to access SEER-Medicare data. CPRD receives ethics approval to supply patient data for all protocols. Because of this, and the fact that all data are de-identified, no IRB approval or exemption are required. Our study protocol to access the CPRD data was reviewed by the CPRD Independent Scientific Advisory Committee. Provision of the CPRD data required a data use agreement. All transformations of the raw data were completed as part of the process of creating analysis data sets for approved study protocols. No clinical data was analyzed or reported for this study.
: Not applicable.
: Outcomes Insights provides consulting services and license software for implementing research protocols using observational data.