Download December 2015

December 2015
Research Coordinators Newsletter
INSIDE THIS ISSUE
Announcements
Announcements
The next Clinical Coordinators Quarterly Update is scheduled for Tuesday,
March 15, 2016. The session will be held from 11:30—1:00 PM in the Wittson
Hall Amphitheater (WHM 3034). Next quarter’s topic: Subject Recruitment!
Presented by Tim Widman, Clinical Research Outreach Coordinator. Tim’s role
in the CRC is to help increase patient recruitment for clinical trials.
Research Event Notification
Breaking the Glass
Assigning PI Effort to Clinical
Trials
IRB Updates
Introducing these new staff:
Krista Brown Clinical Research Associate—Eppley
visit http://www.unmc.edu/cctr/index.html for all your Clinical Research Needs
Research Event Notification
Presented by Courtney Kennedy, Clinical Research Advisor
Editors
Deborah Meyer, RN, BGS,
Assoc. Research Subject Advocate
Linda Wilkie, VT, BS
Director Communications Office of
Research
Sponsors
LuAnn Larson, RN,
Nurse Manager CRC
Chris
Assoc. Vice Chancellor for
Clinical Research & Vice President
for Research
The notification that an enrolled study participant has been admitted to our
campus is being re-instated with some changes to One Chart in the near future.
When live, an alert will appear in both the Principal Investigator’s and
Coordinator’s In Basket when a participant has been either admitted to our
hospitals or visits the ER.
Notifications will be sent only for study patients who are actively enrolled in an
Interventional or Therapeutic study. This alert does not apply to participants
enrolled in a registry or single blood draw studies.
The alerts will be automated therefore it is imperative that study personnel
changes be sent to Courtney Kennedy (402-552-2983 or
[email protected]) so that the notifications can be directed to the
appropriate persons. Although the notifications will be automated the
coordinators will still need to routinely check their In Basket ->Research
Notification folder to see if any of their study patients have had an event.
This tool is being implemented to assist with timely adverse event reporting.
The In-Basket functionality is NOT currently operational. You will be notified
before the alerts begin.
Breaking the Glass
Presented by Tara Scrogin, Interim Chief Compliance Officer and
Debra Bishop, Campus Compliance Specialist
Breaking the Glass (BTG) is the term we use to describe the application pop-up
in One Chart to alert users that they are accessing confidential patient information which is restricted to a “need to know” basis.
All patient records are to be accessed only to perform essential job functions
but there are additional protected categories of which you need to be aware.
Some patients are explicitly identified as confidential (employee, prisoner, etc.),
all patients in some departments are also confidential (psychiatry), as are certain legal lockup charts. Accessing these records without adequate reason can
lead to disciplinary action up to and including termination.
Break the Glass
Exemptions will be
changing
Q1 of 2016
Prior to January 2016 many enterprise employees had exemptions and did not
receive BTG pop-ups. This will be changing in the first quarter of 2016. The
compliance office in concert with clinical leaders are developing policy across
the enterprise to ensure patient privacy. The policy will include criteria for exemptions, implementation for department specific overrides, and more encompassing BTG reasons and how they are to be used.
One area that Coordinators may encounter that involve BTG is screening for
patients to enroll in a particular study. It is important for Coordinators to ask
themselves: are there other ways to obtain the necessary information? For example, is exclusion criteria readily available in the visible record? Is this information that can be asked during an interview process? i.e. Screening for a
psych history is not an adequate reason to BTG, you can see if they are on medications for a psychiatric illness and you can ask the patient for that history.
Once you have broken the glass and entered a restricted view area the compliance officer is notified and these instances are tracked. If confidentiality has
been breached the patient is notified and given explicit detail of the breach including your name, the date, and what information was accessed.
BTG is intended to protect users with access to One Chart. Training on confidentiality and Breaking the Glass will be provided annually, during employee
orientation, and periodically as needed.
Assigning PI Effort to Clinical Trials
Presented by Deb Vetter, Director of Sponsored Programs Administration
Board of Regents Policy
states:
You may not use public
resources for private gain
SPA’s practice to require principal investigators (PI) to devote measurable effort
on sponsored projects may create problems when budgeting for clinical trials.
SPA’s directive is to assign PI effort to each sponsored project, with the minimum being 1%. Clinical trials, on the other hand, may require only a small
amount of PI effort. Often the PI’s effort on a clinical trial is dependent on patient enrollment. Therefore the practice of charging PI effort for “the life” of the
project may not align with the timing of the PI’s contribution.
To accommodate, SPA will accept less than one percent effort for industrysponsored clinical trials and invites units to consider using one percent for one
or more quarters. For example, if a PI earns an annual salary of $100,000, devoting one percent effort over one quarter (0.25 percent effort) would equate to
$250, a surprisingly small amount. For this reason, SPA encourages the research team to consider the scope of work and required duties—e.g., protocol
oversight, CRF review, adverse event review—in estimating the necessary level
of effort.
One of the duties of the research coordinator is to translate the sponsor’s
budget to “communicate” with our accounting system using SPA’s internal
budget form in ADIS. The Personnel category of the internal budget lists the
effort required for the PI to administer the trial. Whether the study recruits 5 or
50 patients, the PI effort would not change significantly. Some physician PIs
also treat patients as part of the clinical trial. In this case, the professional fees
associated with the research related patient care costs may be charged to the
sponsored project. Patient care cost (pro fees) are then captured as an operating expense on SPA’s internal form. Unlike personnel costs, these operating
costs will significantly increase if the study recruits 50 as opposed to 5 patients.
Finally, SPA advises that you wait to charge the PI’s salary to the project until
they are investing time. Should Sponsored Programs Accounting call (as a compliance check that PI effort is being charged), it’s appropriate to tell them that
we need to wait until patients are enrolled before salary is applied to the project.
To summarize: PI effort is required whether or not salary is paid, use less than 1
percent effort if adequate, wait until the PI is devoting effort to the project before charging salary in SAP.
Contact Deb Vetter in Sponsored Programs Administration if you have questions.
IRB Updates
Provided by Jenny Kucera, IRB Administrator/Education Coordinator
Several questions have come into the IRB Office during the last quarter. The
information below addresses some of these questions, providing additional information on protocol changes using referenced protocols, how to change a
Principal Investigator, and IRB approved registries/tissue banks.
It’s important that the IRB application reflects the most current version of a protocol. To insure that the IRB reviewers only need to reference the current version of the protocol, update all the sections of the IRB application when referencing protocols not just the section that has been changed. For those sections
which were not changed simply add the comment “No changes. Updated reference only”. When referencing page numbers in a protocol please use a “clean”,
non-track changes, version to avoid any version confusion.
If you have occasion to switch a person who is already listed on the study and is
“authorized to consent” in Section II status to Principal Investigator (PI) you can
first make the necessary changes in Section I of the IRB application, then put
the Informed Consent Form (ICF) into edit mode which then will automatically
update the ICF with the new PI. If you are removing their authorization to document consent then you must update both Section II of the IRB application and
the ICF manually. This applies to all research applications. However,
“Authorization for Consent” in Section II of the tissue banking and data registry
applications must always be revised manually.
An IRB application may be necessary to access tissue samples or registry data
even when the Biorepository or Registry is already IRB approved. This is frequently the case when data or samples contain any of the 18 HIPAA identifiers.
Please contact the IRB office before initiating any study utilizing a Biorepository
or Registry to determine whether you need an IRB application to proceed.
Have questions?
Consult the UNMC Research Handbook, online at:
http://www.unmc.edu/vcr/about/research-handbook-web.pdf