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Clinical Trial Resources


Double click on the link below to enter the Clinical Research/Clinical Trial Policies, Procedures, Forms, Templates, Practice Aids Share Point site.

https://uofr.rochester.edu/SiteDirectory/ORPA/CTP/default.aspx

The Clinical Research Billing Policy is effective April 1, 2011. On-line training for policy adoption is available as follows:

Course CT-01
Overview of Clinical Research Billing Policy and Standard Operating Procedures
Principal Investigators, Department Administrators, Study Coordinators

Course CT-02
Registration and Billing for Clinical Trials
Registration and Billing Staff

Course CT-03
Clinical Trial Finance (Budgeting and Negotiation)
Department Administrators and Study Coordinators

Course UR ORPA COI Policy
UR Conflict of Interest Policy

The self-enrollment instructions for each course are in the Shared Documents folder titled
"Training and Educational Resources" in the Share Point site.

The Clinical Research Standard Operating Procedures Regarding Financial Oversight and Billing Compliance(SOP) reflects the expectation for current practice. The content contains controls to mitigate the opportunity for billing errors and also reflects sound business practices to ensure a clinical trial is financially sustainable.

Sections of the SOP that are highlighted in yellow refer to (1) templates and forms created to ensure a standard approach to budgeting and monitoring clinical trial activity across all departments/divisions at the institution. and (2) revised internal procedures/policies as a result of adoption of those templates and forms. The forms and templates are contained in the following folders in the Share Point site: Clinical Research Standard Operating Procedures, SOP1, SOP3 and SOP 5.

You are not required to use the forms and templates referred to in the previous paragraph until the implementation date that is assigned to you. Furthermore, the revised internal policies/procedures will not apply until your assigned implementation date since they are associated with the revised forms and templates. As of your implementation date, the forms, templates revised internal policies/procedures will only apply to clinical trials in the negotiation phase and trials in the process of enrolling their first patient. All other existing trials will be grandfathered to your existing practices.

Approximately five departments per calendar quarter will be required to adopt the forms and templates (including adherence to the revised internal procedures/policies). The phase-in approach is being followed because of the additional training, mentoring and IT resources that will be required. The implementation date for the first five departments was July 1, 2011.

The Share Point site also contains links to web sites that contain information or documents referred to in the SOP. It is advisable to add some of these links as Favorites in your web browser.

Site content will be updated periodically. Notices about changes and updates will be posted to the Announcements section of the Share Point site. Also, an ORPA-L will be issued to announce major policy or procedure updates.

If you have any questions about the Clinical Research/Clinical Trial Policies, Procedures, Forms, Templates, Practice Aids Share Point site, its contents, the training and/or the implementation plan, please contact

Michael Ritz
Research Compliance Officer
Phone: 276-4069
Email: Michael.Ritz@rochester.edu