Activity #7: Study Activation
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Activity #7: Study Activation
For industry-sponsored studies: If the sponsor agrees in writing (i.e. by e-mail) to provide funding for start up costs, the principal investigator can open an Advance Account. These accounts can be used to start recording your expenses early, prior to contract execution of the entire Clinical Trial Agreement. To set up the advance account, contact HS Contract-Clinical Trials Contracts. The Advance Account request form is located on the Health System Contracts - Clinical Trials Contracts webpage.
Once you receive IRB approval and the Clinical Trials Contract is executed by both UC Davis and the sponsor, you can open a DaFIS account. The HS contracts office notifies Extramural Accounting and they set up the extramural account. Once the DaFIS (Kuali) account is set up, the financial manager or CRC opens the Bulk Account. With the introduction of the EMR Billing Functionalities in July 2014, the bulk account number is generated by the Epic EMR system upon the completion of the Research Study setup. See Activity 9 for more information.
The Bridge is a database that houses the information needed to create a research study record in the EMR. The Bridge links IRB approvals with EMR study files. A Kerberos ID and password are required to access the Bridge data.
Per P&P 2317, all research studies (expedited and fully reviewed) that meet one of the following criteria must be documented in the Bridge and Epic and the study participants (subjects and controls) must also be associated in EPIC:
Upon review and approval of the UCDHS Compliance Office, some exceptions may apply.
CTSC SOP#13 takes users through the steps necessary to complete the Bridge information and to transfer the study into the EMR. Also please refer to Activity 9 for details.
1. Send request and sign the User Agreement for the Bridge: https://ctscassist.ucdmc.ucdavis.edu/redcap/surveys/?s=INFGig
2. Login into the Bridge (https://ctscassist.ucdmc.ucdavis.edu/redcap/) using Kerberos password.
Follow the procedures outlined in CTSC SOP#13 to annotate the required information in the Bridge. Information required to complete a record:
- PI Provider ID (drop down list)
- Coordinator Name
- Coordinator PPSID (Employee #)
- Department (drop down list)
- Study Short name
- NCT# (ClinicalTrials.gov), mandatory requirement for billing
- Does the study have patient care services billed in UC Davis Health System?
- Coverage Analysis questions (many) • Determination if this is a qualifying clinical trial
- Physician/coordinator attestation
- Upload Billing Grid (if any)
- DaFIS Number, Valid (start) dates and Valid (finish) dates
24-48 hours after clicking “Ready to Upload” the updated information will be displayed in the EMR.
Once the study is in EMR it needs to be further annotated using the Research Home Dashboard. Only Research Coordinators with the EMR CRC template (RC 110) have access to the research dashboard. Other clinical research staff should save these activities as Favorites (using Epic button).
Research Study Maintenance
This hyperlink on the Research Dashboard will take you to research study file in EMR. Several tabs have to be annotated to complete the Study Maintenance:
- Study information and description” The short study name, IRB approval #, study code, and a full description of the Study name appears in this section.
- Users and Providers” tab is used to update or add Principal Investigator and Coordinator’s information.
- Billing Setup.” For all studies, independent of the payor type, click “Create Records Necessary for Billing.” This generates “dummy patient record” and initiates tracking of research-related charges.
The Bulk Account is used to place clinical study specific charges for hospital and professional patient care services. Salaries and other expenses are posted directly to the DaFIS account. You can use your Coverage Analysis Billing Grid as a tool to direct and review charges billed to the Bulk Account.
Starting July 2014, the Bridge supplants the paper Bulk Account Application Form for most studies. A “Dummy Patient Record” (equivalent of the Bulk Account) is now generated by using EMR functions. The tab “Billing Setup” in the Research Study Record must be completed. For all studies, independent of the payor type, the study coordinator must click on “Create Records Necessary for Billing.” This generates “dummy patient record” and initiates tracking of research-related charges. The ”dummy patient record” must be generated in EMR for each study whether or not bulk billing is actually required.
The paper Bulk Account Application Form may still be used for studies conducted on UC Davis campus. For policy on establishing a Bulk Account via the paper process, see Hospital Policy and Procedure # 1815
CTSC SOP#13 provides step-by-step information about the Billing Setup in EMR for research studies
Clinicaltrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Title VIII of FDAAA, Public Law 110-85, amended the PHS Act by adding new section 402(j), 42 U.S.C. § 282(j). The new provisions require that additional information be submitted to clinicaltrials.gov established by the National Institutes of Health (NIH)/National Library of Medicine (NLM). This includes expanded information on clinical trials and information regarding the results of clinical trials.
At UC Davis, we need to be cognizant of the studies initiated by our investigators. This ct.gov registration requirement applies to:
- Any study initiated by a UC Davis investigator under IND/IDE would have to be registered and results uploaded in the timely manner. The Sponsor-Investigator submits a certification (FDA Form 3674) attesting that the data will be submitted as available. Single patient, emergency use INDs do not fall under the referenced section, and therefore are not required to submit certification.
- Any study not conducted under IND/IDE but involving drug or device
- Studies that intend to publish in scientific peer-reviewed journals need to be registered and results entered into ct.gov. Investigators intending to publish clinical studies results in an ICMJE journal (International Committee of Medical Journal Editors) must register before enrollment of first patient. The ICMJE clinical trial registration policy requires prospective registration of all interventional clinical studies, but does not require results reporting for registered trials. In June 2007 the ICMJE adopted the WHO’s definition of clinical trial: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.
Non-compliance with clinicaltrials.gov registration may result in fines up to $10,000/day.
In 2013, the Centers for Medicare and Medicaid Services (CMS) issued a Transmittal requiring new mandatory reporting of the clinicaltrials.gov clinical trial number (also known as NCT#) on all hospital and professional claims for related items/services. Effective January 1, 2015, it will be mandatory to report the clinical trial number on claims for items/services provided in all clinical trials that are qualified for coverage. In order for the NCT# to correctly appear on the claims, the study teams need to type the number in the corresponding field of the BRIDGE.
As of August 2013, Clinicaltrials.gov (NCT#) must be added in the BRIDGE for all studies.
For UC Davis-specific instructions on how to register a trial on clinicaltrials.gov, please reference CTSC website
NIH Guidance on ClinicalTrials.gov Registration Requirements: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
ClinicalTrials.gov Protocol Registration System: http://prsinfo.clinicaltrials.gov/
The Clinical Engineering Department provides a wide scope of medical equipment planning, installation, repair and maintenance services to the UC Davis Health System (UCDHS). Specialty areas include: medical imaging, respiratory therapy, dialysis, radiation therapy systems, anesthesiology, operating room, ICU equipment and medical device integration with IT systems.
For licensed facilities, various regulations and policies require that ALL medical devices be tested before clinical use and those tests must be documented. Clinical Engineering assures compliance with these relevant medical device service regulations including: the Joint Commission, CMS, State of California Department of Public Health, NFPA 99 and others.
The FDA-approved equipment used on human patients at UCDHS requires evaluation and testing by Clinical Engineering. For example, blood pressure monitors and EKG machines sent by an industry sponsor to support multicenter drug trials also need to be reviewed. Another example would be if a researcher was studying under an IRB a new, not-yet-approved, ultrasound contrast material provided by a pharmaceutical company, and was using the pharmaceutical company owned, commercially available, ultrasound machine, the ultrasound machine would need to be checked by Clinical Engineering.
Studies with medical devices that have not yet been FDA approved require an IRB approval, and the evidence of the IRB approval should be provided to Clinical Engineering. For each device that is not FDA-approved, the following information needs to be provided to the Clinical Engineering Department by the Principal Investigator:
- List of equipment that is not FDA-approved.
- A short description of the research equipment including its FDA Risk Class or proposed FDA risk class. This may be provided via a copy of the IRB proposal.
- A block diagram of the system if there are multiple components, including all power supplies.
- An operations manual with service information and/or service manual for each component/subsystem.
- For those devices where there are no formal manuals (e.g., prototypes), provide a short description of each device’s function and the technology used.
Clinical Engineering services are available on a recharge basis via DaFIS at a current average rate of $140 per hour. To begin the evaluation process, receive an estimate or request equipment service, call Clinical Engineering at 916-734-2846. Upon the completion of the evaluation, Clinical Engineering will enter the equipment into the CE Database, tag the piece of equipment and provide a report summary, including billing information. CE will determine frequency of calibration, electrical leakage testing, performance testing and preventative maintenance.
For more information, see Clinical Engineering website or give call at 916-734-2846 (http://intranet.ucdmc.ucdavis.edu/cehelp/)
UCDHS Policies and Procedures:
Policy and procedure 2242 “Equipment in Patient Care Areas”
Policy and Procedure 2245 “Research Equipment”
Policy and Procedure 1653 “Electrical Equipment in non-patient care areas”
Policy and Procedure 1655 “Maintenance and Quality Assurance of Laboratory Equipment”
Please see Activity #11.8 for ideas of who to organize your documentation in the binders.