Principles & Procedures for Endpoint Review
For the purposes of this procedure document, an endpoint is defined as a variable that is validated with a medical record and/or team of experts.
Endpoint review and data release procedures including review of cause of death, cardiovascular events, stroke, dementia, cancer, hip fracture, kidney disease, and all other FHS health events derived from FHS Medical History Surveillance (e.g. exams, callbacks, medical history updates). These are in addition to other measures that the FHS contract or ancillary studies may make.
The Endpoint Review Manual of Procedures (MOP) documenting definition of events must be submitted to FHS Project Manager, Michelle St. Paul (firstname.lastname@example.org), for FHS web posting including:
- Methods of tracking, validation, and adjudication of events;
- Data collection form(s) for endpoint review;
- Composition and training of the review panel; and
- Methods for data entry and QC
- The data collection form (s) must be reviewed by the FHS data manager prior to data collection.
- Data collection forms should have a version date. Any changes to the form need to be instituted in consultation with the FHS data manager and documented in the MOP.
- Events databases are to be updated and provided to the FHS data manager yearly for release, in a manner similar to FHS SOE cardiovascular event files. Released yearly will be events reviewed and adjudicated through December 31 of the preceding year (e.g. December 31, 2018 for the 2019 release). Updated files will be accessible to all FHS investigators and the scientific community and deposited into BioLINCC and dbGap annually.
- Please notify the FHS Executive Committee of any change in the procedures for event review and adjudicated phenotype.
- Review sessions are open to any investigator for observation; location/time of review session are to be posted.
- All events and phenotypes that are used in publications, must be documented through an MOP, and must be returned to FHS annually.
Last Updated: 3/12/2019