Guidance on ClinicalTrials.gov Regulatory Changes as of 1/18/17
Summary of new requirements can be found on the Research Navigator. Access 12/20/16 Partners presentation webcast and slides.
Summary of new requirements can be found on the Research Navigator. Access 12/20/16 Partners presentation webcast and slides.
If you are currently receiving NIH funding for clinical trials research or will be applying for NIH funding to support a clinical trial, you must complete training in GCP. See the NIH Policy here. For more information on GCP, visit Research…
As of January 2017- Investigational Device Exemption (IDE) form re-implemented for use by study teams, requested by Research Billing Compliance, supported by Chief Academic Officer Paul Anderson
As of March 2017, Principal Investigator effort on patient care corrections are no longer vetted by Research Billing Compliance. Audits will be completed in August 2017 to ensure accuracy of claim adjustments.
As of March 2017, Medicare Coverage Analysis (MCA) meetings for Qualifying studies have commenced since Epic go-live. Research Billing Compliance will contact study team to schedule a review of the Partner’s MCA, study budget, consent, and BWH workflow requirements.
As of March 2017, Research Billing Compliance is recommending all Qualifying trials request a review from Partners CTO when a protocol/consent form amendment affects clinical care.
As of March 2017- Research Billing Compliance have reinstated their Internal Routine Audit program: one study will be selected at random and a second will be selected based on a targeted risk analysis. Study teams will be directly contacted, requested…
In March 2017, a change was made to the default charge routing logic in the Epic Research Billing Review (RBR). Prior to this change, charges for services associated with (or “linked” to) research would default to the “Study-Related – Bill…