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Lifespan Clinical Trials Office
The Lifespan Clinical Trials Office was established by the Lifespan Office of Research Administration to provide specialized, centralized and timely services for our Investigators who conduct clinical trials. Please contact us anytime with suggestions, requests for training, or any clinical-trial related questions.
Please be sure to take a look at our quarterly newsletter, which provides helpful guides and tips.
Clinical Trials Compliance Administrator
Gina L. Johnson
Senior Research Administrator
About Clinical Trial Billing
Federal oversight of the academic health center (AMC) research enterprise has expanded in recent years, in part, to some well publicized incidents in research involving human subjects. Regulations cover an increasingly broad spectrum of research operations and touch all research processes from human subjects to budgeting, billing and reimbursement.
There are no signs that the intensity of the regulatory environment is abating. Rather, governmental rules and regulations are multiplying. Along with other AMC, Lifespan leaders view compliance as an ongoing and evolving function particularly with regards to clinical trials.
Compliance programs for clinical trials comprise multiple elements that include budgeting, billing, training, auditing and monitoring. One of the most critical areas of concern is the billing of services for subjects in clinical trials. In response, Lifespan is in the process of creating a new clinical trials billing process with the addition of the newly created position of manger, clinical trial billing compliance, Deborah Temple, who can be reached at firstname.lastname@example.org.
Does this apply to your study?
Clinical trial billing issues apply only to studies that involve human subjects and consist of more than just survey activities, chart review, or the creation of a limited data set. If your study does not have human subjects, or consists only of surveys, chart review or limited data sets, then you do not need to be concerned with these billing rules.
For all other studies with human subjects, if you can answer "YES" to the questions below, then you must apply the clinical trials billing rules to the items/procedures that are performed as part of the study:
- Does the study involve the use of a non FDA approved drug or device (e.g., IND or IDE) or the on or off-label use of an FDA approved drug or device?
- Does the study involve a clinical intervention or other type of research intervention with subjects, such as lab test, EKG, x-rays, MRI or any other procedure?
- Are any intervention tests or procedures performed by or at a Lifespan affiliate (Rhode Island Hospital, The Miriam Hospital, Newport Hospital or Bradley Hospital)?
The Lifespan Clinical Trials Office publishes a newsletter, Clinical Trials Quarterly, which provides the latest news, helpful guides and tips.
Read our recent issues:
- Clinical Trials Quarterly, Volume 1, Number 4 (July 19, 2016)
- Clinical Trials Quarterly, Volume 1, Number 3 (May 11, 2016)
- Clinical Trials Quarterly, Volume 1, Number 2 (January 21, 2016)
- Clinical Trials Quarterly, Volume 1, Number 1 (November 16, 2015)
Clinical Trial Billing Presentations
Kelly Willenberg, an outside consultant from Synergism, held trainings during the week of October 4 to 6, 2011 to help prepare us for completing the Coverage Analysis. These sessions are posted on our website for new hires and anyone who was not able to attend our recent two day seminars or maybe just to refresh your memory.
- An Overview of Clinical Trial Billing: 10/4/11
- Understanding and Preparing the Coverage Analysis: 10/4/11
- A Brief Overview of Good Clinical Practice: 10/5/11