UNIVERSITY OF VERMONT
CLINICAL RESEARCH CENTER
COLLEGE OF MEDICINE
COORDINATOR’S
HANDBOOK
FLETCHER ALLEN HEALTH CARE
MCHV CAMPUS, BAIRD 7
111 COLCHESTER AVENUE
BURLINGTON, VT
(802) 847-2793
2/12/2016
1
05401
Table of Contents
Introduction ............................................................................................................................ 3
General Information .............................................................................................................. 4
Important Details ................................................................................................................... 7
Scheduling ............................................................................................................................... 9
Informed Consent ................................................................................................................ 10
Nursing .................................................................................................................................. 11
Biochemistry Core Laboratory............................................................................................ 12
Mass Spectrometry ............................................................................................................... 14
Physiology.............................................................................................................................. 15
Imaging Core Facility ........................................................................................................... 18
Bionutrition ........................................................................................................................... 19
Research Subject Advocacy (RSA) Office ......................................................................... 21
Informatics ............................................................................................................................ 24
Services Provided: ................................................................................................................................................... 24
Pharmacy ............................................................................................................................... 25
Study Highlights.................................................................................................................... 26
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Introduction
Welcome to the Clinical Research Center (CRC)! Our CRC is one of
approximately 70 centers nationwide that make up the CRC Program. We are
funded by the National Institutes of Health (NIH) to provide scientists the
infrastructure necessary for the efficient and productive conduct of high quality
clinical research. We support both inpatient and outpatient studies and offer
services to the investigator in the areas of administration, nursing, nutrition,
laboratory (biochemistry, physiology, and mass spectrometry), biostatistics,
computing, and pharmacy.
This manual is written for investigators, study coordinators, and other study
personnel who will be conducting the day-to-day mechanics of a CRC-approved
study. We suggest that you review this manual before scheduling your protocol
meeting. Our hope is that this manual will acquaint you to the processes involved
with conducting research on the CRC and will serve as a reference manual to you
throughout your study. Its scope is limited to the “nuts and bolts” of using the
CRC but you can consult http://www.uvm.edu/~gcrc for complete details
about our services.
The CRC staff is committed to helping you conduct the best study possible. Clear
communication between study personnel and the CRC staff is essential for things
to run smoothly. We encourage you to ask questions and discuss your intentions
and expectations with us. We look forward to working with you!
Sincerely,
The CRC Staff
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General Information
BEFORE YOU START YOUR STUDY…
 The Scientific Advisory Committee (SAC) and the Institutional Review Board
(IRB) must approve your protocol and consent form. If you have not yet done
this refer to http://www.uvm.edu/~gcrc or contact the Administrative
Director for details.
 Log onto http://www.uvm.edu/irb/ and take the mandatory on-line tutorials
on the Protection of Human Subjects in Research and HIPAA.
 Privacy regulations mandated by the Health Insurance Portability and
Accountability Act (HIPAA) require that study participants must receive a
HIPAA authorization form. Refer to Section XIV for more information.
 After approvals are obtained, schedule a protocol meeting to discuss the details of
your study with the CRC staff. Contact the Staff Assistant to set up this meeting.
 The CRC needs a copy of your IRB-approved and stamped consent form and
HIPAA Authorization. These documents should be sent electronically to the
Staff Assistant prior to the protocol meeting.
 Contact the primary nurse assigned to your protocol when you’re ready to
schedule the first volunteer for your study. If it has been awhile since the
protocol meeting or there have been changes in the protocol or personnel, a mini
meeting with the CRC staff may be necessary for last minute clarifications.
 You will need to obtain a FAHC Computer Account (M#) if you are not a FAHC
employee and your study requires that you have access to lab data or the CRC
computer system. Contact the Informatics Manager to arrange for this.
 Contact Colleen Williams at 847-9473 to obtain a 960 number to cover any extra
lab tests that are not covered by the CRC. A list of CRC covered tests is included
in the paperwork given to you by the SAC committee. This should be done prior
to the protocol meeting. Have this number available at the protocol meeting.
 Decide if you want your study to be announced in Study Highlights or your
recruitment posters added to CRC bulletin boards. See Section XIII for more
details.
 This manual includes information about Nursing, Biochemistry, Mass
Spectrometry and Physiology Labs, Bionutrition, the Research Subject Advocacy
Office, the Informatics Lab, and Pharmacy Services. Please take the time to
familiarize yourself with the CRC departments and services that your study will be
using.
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WHILE YOUR STUDY IS ACTIVE…
 The IRB will review your protocol at least once a year. You will receive the
approved consent form with an updated IRB stamp. Please remember that the
CRC needs copies of these updates. These must be sent electronically to the CRC
Staff Assistant.
 Concurrent with the IRB review, the Office of Research Subject Advocacy (RSA)
will review all adverse events reported for your protocol. To assist you in
maintaining compliance with federal research mandates, the RSA Office will
prepare a detailed summary of the events for your review and signature. Please
refer to the Section X for more details about the RSA Office.
 You will be asked to contribute to annual reports and renewal applications to the
National Institutes of Health (NIH). Your contribution is necessary to ensure
continued availability of CRC resources to support your research.
 Please acknowledge the University of Vermont Clinical Research Center in any
publications in which data from your CRC study appears (this does not apply to
industry-sponsored “D” studies).
 You may work in the space located in back of the outpatient office (Baird 731A
and 731B, we have added room 749). For your convenience, the space is
equipped with computers, telephones, a photocopier, and a printer.
 Please make copies of any paperwork that you need for your research files. The
originals must go into the FAHC chart.
 The CRC laboratories are not CLIA-approved. This means that data (hematology,
DEXAs, etc.) generated from our labs cannot be used in the diagnosis, prevention
or treatment of disease, or assessment of health. The MD responsible for your
protocol is the only person who can discuss research results with volunteers.
Research coordinators or PIs, who are not MDs, may NOT give out information
generated on the CRC.
 Information obtained as a result of participating in a research study goes into the
individual’s medical record in the Clinical Research section. Information in this
section is not to be released or used for any purpose unrelated to research.
Unauthorized or inappropriate use of research data would be a violation of CLIA
and HIPAA regulations.
IF YOU CHANGE YOUR PROTOCOL after initial SAC and IRB approval…
 Contact the Administrative Director to find out what documentation is required
to process the change. This is especially important if you would like the CRC to
perform more services.
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WHEN YOU FINISH YOUR STUDY…
 Please send a message to the Administrative Director when you complete the
planned data collection, and the sample and statistical analyses for your study. A
copy of the closure letter you submit to the IRB is acceptable. Should you need to
reactivate the protocol, this can usually be handled administratively.
 If your study appears in Study Highlights and you’ve recruited all of you
volunteers, please let the Scheduler know so your listing can be removed.
 Please remove study information displayed on any CRC bulletin boards.
Equipment, paper files and other supplies that won’t be used for another protocol
need to be removed from the CRC to keep the space flexible and open for other
users.
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Important Details
 All visits utilizing CRC space or personnel must be scheduled in advance using the
CRC scheduling system. See Section III for complete details.
 It is your responsibility to be sure that we have signed (handwritten, not stamped)
MD, NP, or PA orders on the unit before your volunteer arrives. Orders must
contain the volunteer's correct name (i.e., the name they would list on their
medical records) and complete date of birth on every page of the order. The study
date and any drug dosing requirements are also essential. Please also note if the
subject has any allergies or if there are any particular substances to be avoided
during the protocol.
 Orders requesting Pharmacy support are due at the CRC in the morning two
business days prior to an inpatient admission or an outpatient visit (e.g., orders
for a Sunday inpatient admission or a Monday outpatient visit are due at the CRC
on the preceding Thursday morning). Orders without Pharmacy requirements are
due at the CRC one full business day before the admission or visit.
 We can accept faxed, but not photocopied, orders. Our fax number is 847-1899.
If you fax the orders, please follow-up with a telephone call (847-5098) to let us
know that they have been faxed. This will assure that the order has been received.
 The CRC must have the volunteer’s original signed consent form before any
testing procedures can be performed. See Section IV for more information about
informed consent.
 Please remind volunteers NOT to donate blood for eight weeks before
participating in a study (if applicable).
 Research volunteers receive free parking in the parking garage if they bring their
parking stub to the CRC for validation. If the garage is full or your subject has
difficulty walking, valet parking is available.
How to Valet Park
The CRC is instituting a plan to pay for valet parking for research volunteers in
situations where this level of assistance is required to ensure the validity of the data
collected during testing scheduled at the CRC. Since NIH dollars will be used to
pay for this service, it will only be available for A-day studies. Request for valet
parking and accompanying justification will be reviewed by the Scientific
Adivisory Committee and may be e-mailed to Eileen Devino.
(eileen.devino@vtmednet.org). Volunteers requiring valet parking will still be
asked to initially pay the $8 fee upon arrival at the ACC. Upon discharge from the
CRC, the volunteer’s parking ticket will be stamped, dated and the volunteers
initials will be written on the back of the ticket. The volunteer will be reimbursed
when the ticket is turned back in to the valet parking attendant. The information on
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the back of the ticket will allow Parking Services to invoice the CRC. Please note
that, thus far, it is only the valet parking that has become an issue. Tickets for
regular parking will continue to be validated for all (A and D studies) research
volunteers coming to the CRC and parking continues to be free for anyone
displaying a handicapped parking permit. CRC resources to provide this service
are extremely limited, so we ask your cooperation in limiting requests to cases
where you feel no other arrangements is satisfactory.
Pull up to the valet parking stand at the ACC entrance to the FAHC campus. The
attendant will give the volunteer a claim check and park their vehicle. The CRC staff
will also validate this claim check. If departing before 4:00 pm, the volunteer may call
ahead (847-0382) to have his/her vehicle pulled up and waiting at the ACC entrance.
After 4:00pm, the volunteer should present the claim check to the security officer at
the ACC Information Desk or the attendant in the garage tollbooth. The volunteer
will be given his/her keys and directed to his/her car.
Outpatient Visits
 When the volunteer arrives at FAHC they MUST first stop at REGISTRATION
in the ACC Lobby to obtain a blue hospital card for the first visit only. Please
remind your volunteers to do this.
 Once volunteers arrive on in the CRC, they need to check in reception room 757
they will be directed to the Nursing Station where they will be stamped in and
assigned a room. Please do not start your testing until this has been done.
Inpatient Visits
 Volunteers scheduled to spend the night in the CRC do not need to stop at
REGISTRATION in the ACC Lobby to be ADMITTED to Baird 7.
 If your study requires any radiology testing such as chest x-rays or CT scans, please
pre-schedule the tests with radiology before the volunteer comes to the hospital.
Keep in mind that CT scans are not done on Sunday evenings. If nursing is
required to mark a volunteer’s leg at a certain spot, please let them know the exact
location.
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Scheduling
 All visits utilizing CRC space or personnel must be scheduled 24/hrs in advance
using our web-based scheduling system. Log onto the system by typing our
address into your web browser (tip: add the address to your favorite’s list so you
don’t have to keep typing it).
www.uvm.edu/~gcrc/gcrcSchedForms.htm (note uppercase letters)
 Follow the onscreen instructions. When first learning the system, please take the
time to read all of the instructions carefully for both inpatient and outpatient visits.
 Be sure to include the volunteer’s date of birth and the visit name. The visit name
must correspond to those that you and the CRC staff agreed upon at the protocol
meeting.
 All inpatient visits must list a covering physician. The Principal Investigator
cannot be the covering physician if he/she does not hold a MD degree (or will be
unavailable on testing days).
 Please estimate the amount of time the volunteer will be on the unit. Be as
accurate as possible because this is how we determine the need for staffing and
space.
 Let your volunteer know how long they will be on the CRC and encourage them
to be on time. It is helpful if they allow at least 15 minutes to park.
 The scheduling desk must be informed if the time or date of a scheduled visit
changes or is canceled.
 Visits involving controlled research meals must be scheduled at least one week in
advance. Visits involving Pharmacy must be scheduled at least two business days
in advance (see Section II for specifics on orders involving Pharmacy). All other
inpatient and outpatient visits must be scheduled 24/hrs prior to the visit.
 The scheduler is available to answer questions Monday through Friday 0530 to
1400.
Contact:
Scheduling
Lee Devino
847-2793
eileen.devino@vtmednet.org
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Informed Consent
 All volunteers MUST sign a consent form with a current IRB approval date (the
date is usually on last page) and a HIPAA authorization form at or before their
initial screening visit. The forms must be signed by the subject or parent (if a
minor) and a legally authorized representative.
 No testing procedures will be performed until the informed consent and HIPAA
authorization forms have been obtained. We recommend that the forms be mailed
to the volunteer prior to the initial visit. This allows them ample time to read
them and have questions addressed before arriving on the CRC. Testing can then
start as soon as the volunteer arrives on the unit with the signed documents.
 ALWAYS give the subject a copy of the consent form.
 The CRC must retain the original signed consent (including the lay summary) and
HIPAA authorization forms. We will file them in the research section of the
volunteer’s medical record. Ask the subject to sign two copies if you also need an
original copy.
 Some studies are of a private nature (e.g. studies involving illicit drug use or
sexually transmitted diseases) and participants may be reluctant to participate
because they fear that sensitive information will get into the wrong hands. To
assuage fears, the Principal Investigator (PI) may obtain a Certificate of
Confidentiality from the NIH to assure that none of the study data goes into the
medical record. In these cases all information (e.g. doctor’s order sheets, nursing
guideline sheets, etc) are stored in a locked file on the GCRC. Please let us know
before your study starts if you have a Certificate of Confidentiality.
 The Principal Investigator, Investigator/Representative, Nurse Practitioner,
Physician’s Assistant, or Study Coordinator administers consent forms to the
subject. The details of the study are to be explained thoroughly and the
volunteer’s questions are to be addressed at this time.
 The Principal Investigator is the ONLY one authorized to sign if the consent
specifies the PI. If the consent lists Investigator/Representative signatures, any
representative can sign as long as their name is listed on the protocol cover sheet
submitted to the CRC and the University of Vermont’s IRB.
 If a space for a witness is listed, it MUST be filled in and not left blank.
 The lay summary must reflect what is in the protocol and it should be written so
that it’s understandable (pretend you’re trying to explain the protocol to a third
grader). The primary nurse covering the study will review this at the time of the
protocol meeting.
 Your protocol and consent form are reviewed and re-approved every year. When
the date expires and a new consent is given, please send an electronic copy to Lee
Devino @ eileen.devino@vtmednet.org
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Nursing
The CRC Nursing staff can provide any of the following services if they are requested.
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Assistance with infusion and clamp studies
Assistance with bedside biopsies
Assistance with physical examinations
Cardiac monitoring for specific protocols
Direct venipuncture for blood sampling
Documentation (e.g. source documents, physician orders, patient teaching aids,
nursing guidelines)
Electrocardiogram
Finger stick glucometer monitoring – whole blood glucose monitoring
Intravenous access
Intravenous and oral glucose tolerance testing (IVGTT/OGTT)
Management of arterial lines
Medication administration
Measurement of height and weight
Monitoring of oxygen saturation (O2 sat)
Observation/documentation of side effects
Patient teaching
vital signs
Specimen collections: blood, urine, stool, etc.
Specimen processing after laboratory hours
Thermal Effect of a Meal (TEM) testing using indirect calorimetry
Video camera monitoring of patients
Conscious Sedation
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Additional services may be arranged by contacting:
Nurse Manager
Joan Bertolet, RN BSN
847-4874
joan.bertolet@vtmednet.org
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Biochemistry Core Laboratory
Contact Colleen Williams at 847-9473 to obtain a 960 number to cover any extra
lab tests that are not covered by the GRC. A list of CRC covered tests is
included in the paperwork given to you by the SAC.
 The Biochemistry Core Lab assists the Principal Investigator (PI) and their staff in
the collection and processing of research samples. During the protocol meeting
the sampling requirements (timing, tubes, storage, etc.) of your protocol are
discussed in detail. You are encouraged to talk with the Biochemistry Core Lab
Manager prior to the protocol meeting if your protocol involves unique sampling
regimens.
 After the protocol meeting the CRC staff prepare protocol sheets that describe the
specific details of your study’s sampling regimen. The PI must approve these
protocol sheets before they can be used for the protocol.
 If your study has samples that are to be analyzed by the FAHC lab, you can access
the results on the FAHC network. FAHC employee’s will already have an M# for
this purpose. If you are not an FAHC employee, contact the CRC Informatics
Manager to get an M#.
 The Biochemistry Core Lab no longer offers any radioimmunoassays to
investigators.
 The Biochemistry Core Lab also offers on-line glucose analysis (usually needed for
clamp procedures). A CRC staff member will analyze the glucoses for the first
clamp scheduled for the day. However, if two clamps are scheduled for the same
day, someone from the PI’s group must analyze the glucoses for the second clamp
scheduled. You will be told if you’re the second clamp for the day and responsible
for your own glucose analyses. Keep in mind that you must be properly trained to
perform these analyses. Be sure to contact the Biochemistry Core Lab Technician
at least two weeks before you’d be performing the analyses to arrange for
training.
 If you need an analysis that is not offered by the Biochemistry Core Lab or the
FAHC lab, contact the CRC administrator to discuss your needs.
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Biochemistry Core Laboratory (con’t)
 You are responsible for shipping if your samples need to go to another site.
Samples can be shipped by Airborne Express or Federal Express Monday through
Friday until 5:00pm. The mailroom is located in the Distribution Center on the
first floor of MCHV campus (phone 847-3548). Contact the Biochemistry Core
Lab Technician in advance if you need dry ice.
 You are responsible for lab setups and processing if your study is an industrysponsored “D” study and not an investigator-initiated “A” study. Studies funded
by drug companies typically are “D” studies. Though we won’t set up and process
your samples, we can provide shared lab and freezer space for you to use if you
request it.
Contact:
Biochemistry Core Lab Technician
David Letourneau, BS
847-4820
David.letourneau@uvm.edu
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Mass Spectrometry
For information about Mass Spectrometry, please refer to Dr. Dwight Matthews’
website: http://www.uvm.edu/~dmatthew.
Contact:
Dwight Matthews, PhD,
Chemistry Department
656-8114
dwight.matthews@uvm.edu
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Physiology
Tests Available
 DEXA (Dual energy X-Ray Absorptiometry) - measures bone mineral density and
body composition
Testing Details
1. A urine pregnancy test is required for women of childbearing years (the CRC will do it).
2. For total body scans, a subject is exposed to a small amount of radiation. Exposure is .02.06 mRems of radiation (a chest x-ray is 40 mRems). In lay terms, this is equal to background
radiation in the environment that a person is exposed to in one day.
3. All metal and plastic objects (all jewelry, glasses, barrettes, and belts.) must be removed. A
hospital gown will be available to wear for this test.
4. The duration on the scan is determined by the height and weight of the subject (height and
weight will be measured prior to the scan). Scan time is also determined by scan type.
5. The subject must lie still while the DEXA is scanning. We try to accommodate people who
have difficulty lying flat and every effort is made to make the scan as comfortable as
possible.
6. The results of the scan will be given to the study coordinator. CRC personnel are not
permitted to give written or verbal results to study volunteers.
 VO 2 Max Exercise Test - measures fitness capacity
Testing Details
1. Prior to testing, each subject will be classified according to cardiovascular risk. Please see
risk stratification sheet on the next page. Risk stratification determines the level of
monitoring during the test.
2. Avoid eating a meal or drinking within 2 hours of the VO2 max test.
3. Avoid exercising at a moderate or vigorous pace within 12 hours of the assessment.
4. Empty bladder completely before the test.
5. Abstain from alcohol consumption within 48 hours of the test.
6. Avoid caffeine and nicotine on the day of the test.
7. Wear comfortable, non-restrictive clothing that will “breathe”. Wear appropriate
footwear/sneakers.
8. If subject has an injury that may be aggravated by the VO2 max test, the test may not be
performed.
9. The subject may stop at any time.
 Anthropometric Measurements (Waist/Hip) – provides an estimate of body
fat distribution and is used to assess obesity health risk
Testing Details
1. The subject will be asked to wear a hospital gown.
2. Measurements are recorded in centimeters.
 Strength Testing (CSMI) - Dynamometer can perform isokinetic and isometric
strength testing
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Testing Details
1. Subjects should wear comfortable clothing that isn’t restrictive.
2. Subjects who have a joint or muscle injury should not perform this test.
 Bioelectric Impedence (BIA) - measures total body water
Testing Details
1. Electrodes are placed on the subject’s foot and hand.
2. It will work best if the subject refrains from wearing lotion on the hand and foot location.
3. The subjects should not: eat or drink within 4 hours of the assessment, avoid vigorous
activity within 12 hours, void completely prior to measurement, abstain from alcohol within
48 hours, and avoid diuretic agents and caffeine prior to measurement.
 Skinfold Measurements - measures percent body fat
Testing Details
1. Usually measure five locations on the body with calipers.
2. The subject will be asked to wear a hospital gown. The subject should avoid wearing lotion.
3. Measurements will be taken twice for accuracy.
 Indirect Calorimetry - measures energy expenditure and provides information on
substrate utilization
Testing Details
1. The subject should receive an explicit description of how this measurement is taken.
2. A plastic, clear hood will be placed over the subject’s head. This hood has air continually
circulating through it. The subject will be able to see through the hood. It takes about 30
minutes. During the test the subject shouldn’t talk or sleep and the room should remain
quiet with the lighting subdued.
3. The measurements are made while the subject is lying still in bed.
4. The number of measurements and duration of measurements are determined by the PI.
Please remember that all results from testing performed on the CRC are for
research purposes only and CANNOT be used in the DIAGNOSIS,
TREATMENT or PREVENTION of any disease. If a medical risk is found,
the covering physician in charge of the protocol can report the findings to the
volunteer.
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Physiology (con’t)
Risk Stratification for VO2Max Testing
Risk Categories
Class IV - known heart disease, symptomatic (chest pain, dyspnea on exertion),
known exertional arrythmias
Class III - age >65 years (no known heart disease)
 Class II - more than 2 cardiac risk factors: male >40 years, post-menopausal
female, hypertension, hyperlipidemia, smoker, diabetes, family history of CAD
diagnosed before age 55years old.
 Class I - none of the above
Supervision Guidelines
 Class IV - trained MD in room
 Class III - trained NP or PA conducting test and a trained MD on the floor
 Class II - trained NP or PA conducting test and a trained MD in the hospital
(beeper), aware of test
 Class I - trained NP, PA, PhD, M.D or experienced Research Physiologist
conducting test
All research volunteers must be categorized so that adequate supervision can be
arranged for participation in exercise testing. The physician, physician’s assistant, or
nurse practitioner should complete the Risk Factor Stratification Form as part of the
screening H&P and file in the hospital records. Please communicate Risk Class when
scheduling test with the GCRC scheduler.
Contact:
Senior Research Physiologist
Nate Kokinda, MS
847-0433
nathan.kokinda@vtmednet.org
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Imaging Core Facility
The CRC currently has two ultrasound units that are available for research utilization.
The Sr. Research Physiologist performs brachial and popliteal artery reactivity studies. Other
ultrasound studies may be performed by the PI or may require making prior arrangements with
Radiology.
GE Vivid 7 with multiple probes
This unit is state of the art for ultrasound imaging and specifically designed for cardiac and
peripheral vascular imaging. Matric array probes are available for these activities including a Matrix
12 linear for peripheral vascular work and a Matrix 3 sector for cardiac evaluations. This unit can
also be used for general abdominal as well as obstetric and gynecologic imaging.
Additional probes include a endovaginal (3-8 multiHz), small parts linear (10 mHz), curvilinear (2-5
multiHz) probes and 5 and 7 MHz sector probes.
Acuson XP-10 (with tissue harmonics) with multiple probes
This unit is excellent for general abdominal and for obstetric and gynecologic imaging. Probes
include: 2 curvilinear probes appropriate for abdominal and obstetrical scanning (multiHz 3-5 &
multiHz 4-7), a small linear probe (7 MHz) for peripheral vascular examinations, a sector probe
(4MHz) appropriate for cardiac evaluations, and 2 endovaginal probes for pelvic and gynecologic
examinations (5 MHz & 7MHz).
Other Resources
GE Echopak Ultrasound Reader
The core facility includes a GE Echopak ultrasound reader with DICOM optical disk storage and
off-line analysis.
Contact:
Nate Kokinda, MS
847-0433
nathan.kokinda@vtmednet.org
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Bionutrition
The CRC has its own nutrition department that includes a research kitchen and
personnel trained in nutrition research methodologies. We are equipped to provide
simple or research-specific meals, nutritional and dietary assessments, and nutrition
education for your volunteers. If Bionutrition services are being utilized for your
protocol, please review the following information.
 Please discuss the details of your protocol with the Bionutrition Research Manager
well in advance of the protocol meeting if you plan to use unique diets, formulas,
recipes, or meals. Dietary studies can require a lot of time and planning. The
Bionutrition Research Manager can help you decide which services you need.
 The CRC dietitian must screen all volunteers in protocols that require research
meals.
 Meal pick up days and times must be scheduled at least one week in advance.
 For protocols requiring outpatient meals, you are responsible for coordinating a
time for your volunteer to pick up his/her research meals. Pick-up times and days
are chosen according to food safety guidelines, the workload and hours of the
research kitchen, and the volunteer’s schedule. Meals are dispensed from the
research kitchen (Baird 725). Keep in mind the hours of the research kitchen
when scheduling:
Monday – Friday 0700-1600
Saturdays
Closed
Sundays
0700-1430 (but varies according to production)
Holidays
Open only as needed
 If your volunteers are eating a standardized diet for three days before a
clamp test, refer to the following guidelines for meal pick-up times:
Day of Admission
(not necessarily
day of testing)
Pickup Options
Sunday
Thursday afternoon between 1200-1600 or Friday morning between 0630-1000
(before breakfast)
Friday afternoon between 1200-1600 only unless split pick up (i.e. pick up half of
meals on Sunday)
Sunday morning between 1030-1200
Sunday afternoon between 1200-1400 or Monday morning (preferred) between
0630-1000 (before breakfast)
Monday afternoon between 1200-1600 or Tuesday morning between 0630-1000
(before breakfast)
Tuesday afternoon between 1200-1600 or Wednesday morning between 0630-1000
(before breakfast)
Monday
Tuesday
Wednesday
Thursday
Friday
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Bionutrition (con’t)
 If a volunteer is starting their meals Sunday and picking up their meals on Sunday
they will have to be prepared that morning and, therefore, will not be ready for
pick up until 1030.
 Please ask your volunteer to be on time when picking up meals. We plan
our production around meal pick up times and may not be able to accommodate
volunteers who show up early or late. If a volunteer is more than 15 minutes late
and the CRC is closing, the meals will be placed in the Coffee Shop in the Main
Lobby. However, we don’t prefer this option because we like to review the
instructions with each subject as well as keep the meals in our department (rather
than in the hospital’s nutrition dept where they could get lost). Please have your
volunteers call the kitchen at 847-4738 or 847-3603 or the Bionutrition Research
Manager at 847-4730 if they won’t be able to arrive as scheduled.
 Please encourage your volunteers to comply with the diet and reinforce its
importance. Participants are much more likely to be compliant if they hear the
importance of the diet from other people besides us!
 Please contact the research kitchen at 847-4738 or the Bionutrition Research
Manager at 847-4730 if there are last minute requests or cancellations that
involve the research kitchen. A lot of work goes into planning and producing
research meals and we like to avoid making meals that won’t be used.
 The food in the research kitchen is for research subjects only. Our inventory is
specially prepared and controlled and we are limited as to what we can offer.
Please do not promise your volunteers special products unless you know they are
available.
 If you need a tray for one of your volunteers (and you requested meals for your
study at the time of SAC approval), tell the kitchen the volunteer’s name and room
number and the approximate time you would like the tray. We will get it to them
as soon as possible. Please do not allow volunteers to go into the kitchen.
 We look forward to working with you and your team!.
Contact:
Bionutrition Research Manager
Emily Tarleton, MS, RD, LD
847-4730
emily.tarleton@vtmednet.org
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Research Subject Advocacy (RSA) Office
Background
Growing pressure to enhance and ensure research subject protection has resulted in
the introduction of new regulatory guidelines for those involved in clinical research.
As part of this overall effort the National Center for Research Resources (NCRR, the
NIH agency that funds CRCs) has established the RSA offices in order to create an
internal CRC mechanism to both promote and monitor protocol safety for human
clinical research participants. While the breadth of responsibility for the RSA offices
is incompletely defined, we have established:
1.) data and safety monitoring plans for all appropriate clinical trials
2.) CRC adverse event reporting guidelines
The RSA office has a direct reporting requirement to the Principal Investigator of the
CRC grant but works closely with the CRC Program and Administrative Directors as
well as the SAC (Scientific Advisory Committee) on a day to day basis to outline
monitoring programs and carry them through effectively.
Data Safety Monitoring Plan (DSMP)
The National Center for Research Resources (NCRR) Advisory Council adopted the
“Recommendations to CRCs for Patient Safety in Clinical Research” in May of 2001.
This document outlined the requirement that each protocol that is active within the GCRC
have a Data Safety Monitoring Plan (DSMP). As part of the annual review process, also
mandated by these guidelines, we are requesting that all active CRC protocols submit a
revised protocol including a DSMP.
Data Safety Monitoring Plan requirements
Four elements of a DSMP are required:
1) Adverse events must be graded for severity
2) A plan for reporting adverse events must be in place
3) A plan for annual reporting of adverse events must be in place
4) A plan for safety review (by whom and at what frequency must be established)
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Here is a sample DSMP that the RSA drafted for investigators to use (*only if it is approved by the
RSA):
Data Safety Monitoring Plan
“Adverse events and protocol deviations will be reported by one of 3 mechanisms:
1) The University of Vermont/Fletcher Allen Committee for Human Subject research adverse
event reporting document. These reports will be forwarded to the office of the Committee for
Human Research in the Medical Science (CHRMS 245 South Park Suite 900, UVM) within 5
days of the event with copies forwarded to the Research Subject Advocate (RSA) office within the
l Clinical Research Center (CRC) on Baird 7 within 15 days. This will be the responsibility of the
principal investigator. The CHRMS will make a determination as to whether additional
reporting requirements are indicated.
2) The Safety Alert for Events Reporting Form (SAFE) may be initiated by CRC nursing staff or
study personnel. These forms will be forwarded within 3 days through the nurse manager, or
designee, on Baird 7 to the CRC RSA office where further distribution to; A) protocol principal
investigator, B) Fletcher Allen Risk Management Office, C) CHRMS, D) CRC Program Director,
E) CRC Administrative Director, and other appropriate agencies as indicated by the nature of
the report.
3) Email. An email will be sent to the Research Compliance Specialist in which the email will
include the protocol number and title, the date of the event or deviation, subject initials or
number, and a description of the event or deviation.
All local serious and non-serious events that are documented by study personnel must and will
be reported to the RSA office. For multi-center studies in which UVM is participating, only
serious adverse events and protocol deviations that will be reported to the IRB will be forwarded
to the RSA Office.
All adverse event reports will be reviewed for severity and frequency on their presentation to the
RSA office and will be examined within the overall context of both protocol specific adverse
events and more general CRC processes. Reviews of protocol specific adverse events will be
performed no less than annually. Findings of the RSA office will be forwarded to the Scientific
Advisory Committee for review and action when viewed as appropriate by the RSA office based
on the emergence of protocol specific or CRC unit patterns in adverse event reports.
Studies that require a DSMB in addition to a DSMP will forward all minutes and/or
correspondences to the RSA Office.
Adverse Event Reporting on the CRC
A SAFE report should be completed if an adverse event or protocol deviation occurs.
The principal investigator, the clinical coordinator, or CRC staff may complete a
SAFE report. It is important that the person who observed the incident report it. A
secondary person should not report it (i.e. someone who overheard what happened).
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If the investigator and/or coordinator are not present during the incident it is advised
that the person reporting the incident should notify the principal investigator of the
event. If an event is filed with the IRB by the principal investigator or the clinical
coordinator, a copy of the report should be forwarded to the RSA office. Again, the
goal is to improve the safety of our subjects and the CRC.
Contact:
Research Subject Advocate
Peter Cherouny, MD
847-5111
peter.cherouny@vtmednet.org
Send Adverse Event Reports to
peter.cherouny@vtmednet.org
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Informatics
The CRC Informatics facility is available to investigators with protocols using the
CRC and to those who request support for more limited services such as assistance
with data entry or analysis.
Services Provided:
 Advice on data collection, management, and analysis
 Assistance with database and survey design
 Assistance with using software provided on or by the Informatics Core
 Creation of randomization schemes
 Data storage on file server in secure, HIPAA environment with nightly back-up
 Use of flat-bed (color) or document-feeding (black-and-white) scanners
Some of the software available on the Informatics PC’s (contact the Informatics
Manager for detailed information or if you need specialized software not mentioned):






REDCap electronic data capture tools (secure web-based database)
REDCap survey (tool for building & managing online surveys)
Statistical analysis and sample size/power calculations
MinMod Millenium, (for analyzing minimal model – IVGTTs)
Image manipulations and Optical Character Recognition
TELEform, for creating/reading scannable data forms
Contact:
Informatics Manager
Diantha Howard, MS
656-8287
diantha.howard@uvm.edu
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Pharmacy
Please contact the Research Pharmacists directly.
Contact:
Research Pharmacist
Research Pharmacist
David McGarry, BS, RPh
802-847-4863
david.mcgarry@vtmednet.org
Marcia Dunham, BS, RPh
802-847-4863
marcia.dunham@vtmednet.org
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Study Highlights
Study Highlights is a bulletin that lists protocols active in the CRC. It is posted
prominently throughout Fletcher Allen Health Care and the University of Vermont,
as well as the CRC web site, and also is available to publicity officers both within and
outside the institution. If you would like your research project added to this list, we
need a brief description of the study, the study population, the contact person
and the telephone number (see reverse side for examples).
CRC Minority Outreach Program
The CRC Outreach Program mainly focuses on disseminating information
about opportunities for participation in clinical research. All IRB and CRC SACapproved protocols are eligible, at the option of the investigator, to be processed
through the outreach program.
Information is disseminated by newspaper, radio or television announcements.
Although individual investigators are often required to pay for these services, the
Program has been successful in reducing or entirely abolishing the normal fees
associated with such advertising processes.
Information about research opportunities is also passed along to the Office of
Minority Health at the Vermont Department of Health. Judy Ashley-Mclaughlin
coordinates this office and has formed extensive ties to many communitybased and professional organizations serving communities of color and minorities in
Vermont. These organizations include Abenaki Self Help, ALANA Community
Organization, Austin School for the Deaf, Burlington Community Health Center,
Burlington Council of Refugees and Immigrants, Dawnland Native American Center,
Vermont Refugee Assistance Program, Refugee Resettlement Program, Tibetan
Resettlement Project, and others. Many of these organizations have information
networks in place to disseminate relevant news. The Office of Minority Health also
keeps an up-to-date listing of interpreters who are available throughout the State of
Vermont to translate consent forms and dialogues between investigators and subjects
into any of the numerous languages and dialects spoken amongst these communities.
Please let us know if you are interested in using these services. You can tell us
at the protocol meeting or contact Lee Devino.
Contact:
Scheduler
Lee Devino
847-2793
eileen.devino@vtmednet.org
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Study Highlights (examples)
720 Dr. Ira Bernstein – We are trying to understand the control of blood flow to
the uterus during the menstrual cycle. We need your help. If you are between 18 and
35 years of age, healthy, do not smoke and have never been pregnant you may be
eligible to participate. The study includes visits over 3-4 months, ultrasound
examinations and hormone replacement therapy. Compensation up to $400 is
provided.
Contact: Addie Schonberg 656-2669
728 Dr. Paul Newhouse – Memory & Menopause: This study will examine whether
short-term estrogen use will positively affect the system in the brain thought to
involve memory. Seeking postmenopausal women ages 50-60 and 70+, who are nonsmokers, are not currently taking estrogen or anti-depressants, and have no history of
breast cancer. Stipend will be provided.
Contact: Katie Bucci, M.S. 847-8596
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The HIPAA Privacy Rule & Research
 The Department of Health and Human Services (HHS) issued the Standards for
Privacy of Individually Identifiable Health Information (the Privacy Rule) under
the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to
provide the first comprehensive Federal protection for the privacy of personal
health information. We must comply with this rule.
 In order to proceed with research visits, each new volunteer enrolled in new or
ongoing studies on or after April 14th, 2003, must have an IRB-reviewed, signed
Authorization form. A separate form is required for each of your CRC protocols.
Contact the IRB at 656-4067 to obtain research-specific HIPPA forms.
 As with the Lay Summary/Consent we request that the PI or the coordinator
discuss the information contained in the Authorization with the volunteer and
obtain the necessary signatures. In unusual circumstances and by prior
arrangement with your primary nurse, a CRC nurse may be available to complete
the Authorization process.
 Original signed Authorization forms will be stored with the original signed Lay
Summary/Consent in the research section of the medical record. Our policy that
information in the research section not be released when medical records are
requested by insurance agencies remains in effect. Likewise, research sections of
medical records on studies that have certificates of confidentiality will continue to
be stored in locked files at the CRC.
 In addition to the disclaimer that currently exists on the tab of the research section
of the medical record, individual pages (e.g. datasheets, notes, protocol sheets, etc.)
within this section will now carry a similar notice stating that the information has
been collected for research purposes only and is not intended for clinical use.
Volunteer requests for study data will be referred to the responsible physician on
the protocol.
 Volunteers coming to FAHC for the purpose of participating in research at the
CRC will not be required to sign the FAHC Privacy Statement issued at Admitting.
However, should a volunteer discontinue a research protocol and require care as a
clinical patient, it is the admitting physician's responsibility to ensure that the
patient is discharged from the CRC and admitted to FAHC with the Privacy
Statement completed at that time.
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