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UC Davis Health Research Policies​ | Compliance and Privacy Services | UC Davis Health

UC Davis Health Research Policies

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Information Technology (IT) Evaluations

Researchers should utilize available technology approved for enterprise-wide use whenever possible. Redundant technologies add operational costs and security considerations. In instances that require implementation or use of new applications, systems, or devices, an IT Evaluation prior to the start of the study is required, as new technology may inadvertently create technical instability or create security risks for UC Davis Health. It is recommended that the evaluation precede IRB submission, as it may take several weeks or months to complete. Some examples of research-related technologies that must be evaluated include:

  • Mobile devices that are used to gather study information or e-signatures;
  • Software that will be implemented on the UC Davis Health network or that will be used to access the UC Davis Health network;
  • Clinical devices that require network access or involve data transfer;
  • Cloud-based applications or storage; or
  • Applications or devices provided or purchased for purposes of processing or storing study information.

IT Evaluation (ucdavis.edu employee intranet)

It is important to note that an IT evaluation is restricted to a review of the technical stability, security and feasibility of technology used at UC Davis Health. Approval of applications, systems, or devices does not signify a commitment of IT resources to manage and maintain the technology. Additionally, the approval does not address implementation costs or constitute a financial approval.

Submitting a request for IT evaluation ensures compliance with UCOP Business and Finance Bulletin IS-3 “Electronic Information Security” (PDF) and the UC Davis Health Information Technology (IT) Evaluation Process (ucdavis.edu employee intranet).

Research Equipment

All medical equipment used in conjunction with research in UC Davis Health patient care areas, including rented, loaned, leased, purchased, self-manufactured and personal equipment must adhere to Policy 2245, Research Equipment. All research medical equipment that is non-FDA approved must be part of an approved IRB study.

Before its use, the equipment must be evaluated by Clinical Engineering. Assessment of equipment can be requested by submission of an IT Evaluation request. The cost of this evaluation should be factored into research budgets.

IT Evaluation (ucdavis.edu)

OnCore Clinical Trial Management System (CTMS)

The OnCore CTMS is utilized at UC Davis Health to aid researchers in managing individual studies and study portfolios, research subjects, study finances, and research billing plans. OnCore interfaces with the Epic electronic health record system to create study entries and to update each subject’s study status in Epic. A study entry is required in OnCore for:

  • All biomedical and behavioral clinical trials, as defined by NIH,
  • Studies subject to Policy 2317,
  • Studies that will invoice a sponsor or funding source, and
  • Studies that will utilize Epic research functionality (e.g. MyChart recruitment, Adverse Event Activity).

A full list of OnCore Required Use Scenarios is available at the link below:

General Guidelines and Use Requirements | UC Davis CTSC

Researcher Access to Medical Records

Access to Epic for a research purpose requires a study-specific written HIPAA permission. Examples of access to Epic for a research purpose include but are not limited to:

  • Review of medical history for determination of study eligibility;
  • Utilization of patient look-up to see if a potential study subject has an existing medical record;
  • Entry of a protocol-directed order for a procedure performed solely for purposes of research; and
  • Abstraction of data from a medical record for purposes of completing research case report forms.

See also:

Additional Resources

The topics above are not exhaustive of policy requirements for research. See also:

Research Consents and Authorizations in the Electronic Medical Record (EMR)

The signed research informed consent forms for certain studies and all signed authorization forms must be retained in the patient’s medical record consistent with Policy 2306.

UC Davis Health Policy 2306, Legal Medical Record Content/Core Elements, establishes standards for legal medical record content. Section VI.E. addresses Consents for Care, Treatment, and Research:

For subjects participating in research studies, file the original signed document in the research record, and:

  1. Upload a copy of the signed Permission to Use Personal Health Information for Research (HIPAA Authorization) form to the Media tab in the patient’s EMR.
  2. For studies subject to Policy 2317, Documentation of Research Patient Status in the Electronic Medical Record, upload a copy of the signed Informed Consent Form (ICF) form to the Media tab in the patient’s EMR.

Upload Consent and HIPAA Authorization into EMR - UC Davis Clinical Research Guidebook - Confluence

Documenting Research Activities in the Electronic Medical Record (EMR)

A study is subject to Policy 2317, Documentation of Research Patient Status in the Electronic Medical Record, if one or more of the following criteria are met:

  • The study utilizes a drug or device;
  • The study protocol requires items or services that result in any charge or billing component (including billing to a third-party insurance, study sponsor, or patient) in the Epic billing system; or
  • The study includes, as part of the protocol, any clinical intervention, including the invasion of any research participant (control or subject) body cavity (e.g. blood draw) when such an intervention takes place within a UC Davis Medical Center (UCDMC) licensed facility.

Policy 2317 establishes requirements for engaging research functionality in Epic which is critical to compliance in these areas:

  • Identification of patients participating in research;
  • Availability of general study-related safety information and researcher contact information for UC Davis Health healthcare providers;
  • Bill holds and mandatory charge review to support proper management of charges generated from conduct of research in the clinical setting;
  • Identification of research-related documentation in the EMR, including documentation protected by a Certificate of Confidentiality; and
  • Managing privacy and confidentiality for research subjects.

Policy 2317 describes the activities which must be completed in the OnCore Clinical Trial Management System (CTMS) and Epic to ensure appropriate engagement of Epic research functionality. Also see the Guidebook links below for information and tutorials on research-related OnCore and Epic workflows.

Research Notes in the Electronic Medical Record (EMR)

Medical information documented in a patient’s EMR is released to the patient’s MyChart to ensure individuals may access their protected health information as described in Policy 2301, CURES Act and Information Blocking. An exception provided in the policy and law allows information created during the course of research to be temporarily withheld from access when the research participant provides consent. UC Davis IRB consent templates include appropriate language for obtaining such consent.

Interoperability and Info Sharing (ucdavis.edu) (intranet)

The Research Note type in Epic, by default, delays release of the note to the patient’s MyChart. The Research Note type is available for encounters linked to a study and is intended only for study-specific documentation. The Research Note type is released to the patient’s MyChart when:

  • The note is pre-emptively released by the note’s author, or
  • The study’s status in Epic is updated with an inactive status such as “Complete” or “Inactive, terminated”.

See this Guidebook article for more information:

Research Notes - UC Davis Clinical Research Guidebook - Confluence

Subject Injury

While clinical sites typically provide medical treatment to subjects sustaining injury/complication on a study, who will cover the costs may not always be clear. Industry sponsor, insurance or even self-pay options are considered.

UC Office of the President (UCOP) Operating Requirement Memo 95-05 outlines the requirements for administration of agreements with private sponsors for drug and device testing using human subjects. UCOP Operating Guidance Memo 13-01, provides additional clarification and guidance.

For more information or assistance with determinations related to subject injury, email UCD Health’s Risk Management Department risk.management@ucdmc.ucdavis.edu or call 916-734-3883.

See also:

Policy Resources for Researchers