UNC Metastatic Breast Cancer Clinical Database
UNC Lineberger Comprehensive Cancer Center established the UNC Metastatic Breast Cancer Clinical Database in an effort to track patient demographics, pathology, evolution to metastatic disease, metastatic treatments, and clinical trial enrollment since 2012. In this clinical database, medical records of all metastatic patients seen by the UNC Breast Center are abstracted and updated at 6 month intervals. The clinical database is maintained on REDCap (a free, secure, web-based application designed to support data capture for clinical research); the REDCap database is supported by NC TraCS and grant support from Dr. Claire Dees (Susan G. Komen Foundation) and Dr. Carey Anders (Damon Runyon Foundation).
The primary purpose of the database is to help the UNC breast team make clinical decisions for treatment of breast cancer patients at UNC. The database itself does not inform research at UNC. However, use of the clinical database, a rich data source, for research is permissible with an IRB approval and approval from the OCTR. Use of the Metastatic Breast Cancer Clinical Database will be at the discretion of the project team.
There will be no direct contact with patients from the UNC Metastatic Breast Cancer Clinical Database.
Steps to Access Data
1. Investigator will approach OCTR Database Coordinators with a proposal.
- OCTR Database Coordinators: Julie Benbow and Juanita Ramirez
- Meet in person if possible; email is also appropriate if proposal is straightforward.
- Database coordinators can provide data dictionary (no patient data) showing all fields captured by the database.
2. Investigator will submit a OCTR New Project Request Form to the database coordinators that will need approval from:
- Julie Benbow, Database Coordinator and Honest Broker
- Juanita Ramirez, Database Coordinator and Honest Broker
- Amy Garrett, OCTR Director (Signature required)
- Claire Dees, MD (Signature required)
- Carey Anders, MD (Signature required)
3. Investigators will account for use of Metastatic Clinical Database data in their own IRB application prior to release of data.
- Investigators must present evidence of IRB approval prior to release of data; the approval letter verifying that the use of the REDcap Breast Cancer Metastatic Database has been added to an approved IRB study will be sufficient.
- Investigators may use the standardized language document created by the OCTR for both identified data sets and de-identified data sets.
4. Investigator will sign a Data Use Agreement prior to release of data
- This database was originally designed and created for clinical use by the UNC Breast Team, but we welcome use of the data by other groups at UNC. Database coordinators are unfortunately unable to abstract fields not already included within database. The investigators proposal should work within the confines of the existing data fields.
- Should this data result in a publication, the Susan G. Komen Foundation should be listed in the acknowledgements section.