List of contents
1. Welcome to DCRU………………………………………………………………………..p.2
2. Overview of services………………………………………………………………….pp. 3, 4
3. Contact list……………………………………………………………………………………p.5
4. Pharmacy Service (non-investigational)………………………………………..p.6
5. Laboratory Services………………………………………………………….…………..p.7
6. Nutrition Services………………………………………………………………………pp. 8,9
7. Pulmonary Function Testing services …………………………………………..p.10
8. Recruitment Services…………………………………………………………….…..pp. 11-13
9. Study plan instructions………………………………..…………………………….pp. 14-20
10.Sample study plan…………………….………………………………………..……..pp. 20-24
11. Scheduling instructions……………………………………………………………..pp. 25-28
12. Pulmonary Function Testing Laboratory Scheduling ………………….pp. 29-30
13. Check off list of ‘to do’ items prior to scheduling first subject……..p.31
14. Frequently Asked Questions…………………………..………………………….pp. 32-35
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Welcome to DCRU
Thank you for considering the Duke Clinical Research Unit for your clinical research needs.
Whether you are new to our services or a returning investigator, our Investigator Advocate,
Donna Hamel, is here to help. Donna will guide you through the process and will be happy to
lend assistance at any step along the way. As Investigator Advocate, Donna will also serve as
your primary point of contact throughout your entire partnership with the DCRU.
Therefore; the first step in partnering with the DCRU for the conduct of your study is contacting
the Investigator Advocate, either by phone at 919-684-9966 or via e-mail at
donna.hamel@dm.duke.edu to arrange for a preliminary meeting. If you are unfamiliar with
our services, you will be given a tour of the facilities, a description of available service, and
information that will assist you in getting your study up and running in a smooth and timely
manner. If you are a returning investigator, you may simply need information regarding any
changes in policy or procedures since your last partnership with DRCU. The meeting will be
tailored to your specific needs.
Should you decide you would like to conduct your study with the assistance of the DCRU, you
will be asked to provide the following:
1. Primary contact information
2. A proposed timeline (first subject in / last subject out)
3. A copy of your protocol (draft form is fine)
a. Be assured there will be no breach in confidentiality.
4. A completed service request form
a. The Service request form can be obtained from the Investigator Advocate during
your preliminary meeting.
b. A study specific budget will be prepared for you based on your service requests.
Thank you for considering us for your research needs. We look forward to
partnering with you in your research endeavors.
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Introduction and Overview of Services
The DCRU is a state of the art, thirty bed research unit. DCRU provides the clinical research
infrastructure to support investigators in the design, initiation, and conduct and reporting of
interdisciplinary and collaborative clinical and translational research to help understand human
conditions, translate basic research findings into patient care, and develop new therapies.
DCRU can also be your partner for industry-sponsored studies, offering either full-service
execution of your studies or fee for service.
The DCRU has proven expertise in the following areas:
Allergy/Immunology
Anesthesiology
Bariatric Surgery
Cardiac Surgery
Cardiology
Clinical pharmacology
Endocrinology
Gastroenterology
General Surgery
Geriatrics
Hematology
Hepatology
Infectious Diseases
Medical Genetics
Metabolic Disorders
Nephrology
Neurology
Neurosurgery
Oncology
Ophthalmology
Pediatrics
Psychiatry
Psychology
Pulmonary Medicine
Radiation Oncology
Rheumatology
Urology
The DCRU has the capability to provide services in both an inpatient and an outpatient setting.
The DCRU has 10 hospital graded beds to service the needs of research subjects who require
specialized hospital care during the course of their study visit. Our hospital-based beds
maximize subject safety and provide on-site access to a full array of specialized procedures and
technologies.
The remaining 20 beds are classified as confinement beds. These beds are designed to house
subjects who do not require medical standard of care procedures during their study stay.
Additionally, the DCRU has six well equipped examination rooms, a metabolic kitchen, a
processing laboratory, and wireless internet access.
Subjects have access to wireless internet access and high definition televisions in their shared
rooms. If protocol permits, subjects can also access our multi-purpose room, a subject reading
room, laundry facility, and a large comfortable lounge equipped with games, puzzles, and a high
definition television.
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While on the DCRU, subjects are cared for by a team of hospital credentialed nurses, certified
nursing assistants, certified medical assistants, medical laboratory technicians, phlebotomists,
registered dietitians, and food services personnel. The DCRU also has on site a nurse
practitioner, and registered respiratory care practitioner.
We have immediate, round-the-clock access to an on-site, full-scale emergency response team
and MD coverage. The DCRU also provides extensive security measures for your staff and
subjects, including cameras, alarms, locked elevators, and Duke Security personnel on-site 24
hours a day.
For additional information on the DCRU’s services, contact Donna Hamel, DCRU Investigator
Advocate (684-9966; donna.hamel@dm.duke.edu), or John Sundy, MD, PhD, DCRU Program
Director (john.sundy@dm.duke.edu)
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Contact list
Investigator Advocate
Donna Hamel o. 919-684-9966 / c. 919-724-0584 donna.hamel@dm.duke.edu
Visit Scheduling:
DCRUSched@duke.edu
PFT Scheduling:
DCRU PFT@duke.edu
PFT schedule inquiry:
Janice Hogan
919-668-2262 janice.hogan@duke.edu
Reception:
Gregory Taylor
919-684-1672 gregory.taylor @duke.edu
3N nursing station:
919-684-1673____________________
2N nursing station:
919-684-2551____________________
IRB specialist:
Laboratory Services
Jessica Ghidorzi
Lynn Jordan __
919-684-1783 jessica.ghidorzi@duke.edu
919-668-3033 Lynn.Jordan@duke.edu
Laboratory Services – general contact number
919-684-6888____________________
Pulmonary Function Lab Manager: Donna Hamel
919-684-9966 donna.hamel@duke.edu
Medical Director:
Robert Noveck
919-684-1018 robert.noveck@duke.edu__
Nutrition Services:
Catherine Gang
919-930-5650 catherine.gang@duke.edu
Nursing Services Manager:
Kim DeBaun
919-684-1780 kim.DeBaun@duke.edu_
AD for Recruitment Services:
Lucian Cappoli
31 July 2014 v 1.7
_919-684-1329 _lucian.cappoli@duke.edu
Page 5 of 35
DCRU Pharmacy Service (non-investigational)
Home medications: inpatient subjects
1. Medications Brought from Home: Procedure for non- controlled substances
a. DUHS Pharmacist will verify medication identification
b. DCRU Nurse will then load medication into Omnicell
2. Subject’s own home medication procedure for controlled substances
a. DUHS Pharmacist will verify medication identification
b. DUHS Pharmacist will verify quantity
i. For medications with large quantities, the pharmacist will label a smaller
quantity in a separate medication bottle for use while at DCRU. The DUHS
pharmacist will mark original bottle with quantity and seal with
tamperproof tape for storage in Omnicell. All home medications will be
returned to the subject upon discharge
c. DCRU Nurse will administer doses from the smaller quantity bottle and track the
quantity/usage.
3. Patients will not be permitted to bring in expired medication bottles or medications in
pill boxes.
4. New medication required for medical support to subjects admitted to the DCRU.
a. The order will be placed into CPOE by either the DCRU staff or the study team
b. The DUHS Pharmacy will verify order in HMM system (for controlled substances
only)
c. Inpatient Pharmacy services will provide the medication supply and place it into
Omnicell for dispensing.
Home medications: outpatient subjects
1. Same procedure as for inpatients with exceptions of below
a. All orders will be placed on a written paper order form
b. DCRU staff will page the DUHS pharmacist at 970-0869 to alert that there is a
paper order or home medications for them to verify
c. DCRU staff will fax any new order to fax number 681-7976 from 0700-2300 and
fax
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Laboratory Services
Welcome to the DRCU processing laboratory. The services provided by our laboratory include:
 Specimen Collection
 Specimen Processing
 Specimen Storage- short term only
 Specimen Shipment
 Point of Care Testing
Study Start-Up
We look forward to working with you and making your project a success. We strive to maintain
quality standards and make sure that all samples entering and exiting our laboratory are
documented, processed and stored correctly. To succeed we must work as a team to prepare
for the proper conduct of your study. This includes:
 gathering details about the visit schedule
 Clearly defining the samples to be collected by the DCRU
 Determining what supplies are required and who will obtain them
 Defining the sample processing instructions
 Core Lab, Specialty Lab or PI shipment details
 Managing supplies and sample inventory
 Shipping /sample disposition
 Short term storage requirements
Study Conduct
During the conduct of your study our laboratory services will maintain lab and study specific.
Additionally, if your study requires monitoring visits or is audited, we will be happy to assist in
the laboratory portion of the monitoring or audit visit, however; scheduling arrangements must
be made in advance.
For specific details concerning your study, or to schedule a monitoring / audit visit, please
contact our laboratory manager Lynn Jordan at 919-668-3055 or via e-mail at
michael.bishop@dm.duke.edu.
Our laboratory staff strives to offer the highest quality of laboratory services to
meet your research needs. We look forward to partnering with you in all your
research endeavors.
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Nutrition Services
Welcome to the DCRU Nutrition Services. The staff of our unit provides:
1. Professional consultation services by DCRU registered dietitians (nutritionists)
2. Regular and special meals with protocol-specific nutrition requirements by
Specially trained Nutrition services
In order to better serve your subject’s dietary needs, please consider using the following
terminology in your protocol:
1. Regular Diet- This is defined as a balanced nutritional meal with no specific
requirements. Vegetarian requests should be made in advance.
2. Regular Diet with one or more Dietary Restrictions
a. This refers to a diet plan designed to follow specific guidelines. Dietary
restrictions should be specific. For example:
i. Regular diet: no caffeine, grapefruit juice.
ii. Regular Diet: no broccoli or cauliflower.
3. Special Diet
a. Controlled nutrient intake (for example: 50% Carb/20% Protein/30% Fat )
b. Medical Nutrition Therapy Diets (for example: DASH, Gluten Free)
i. NOTE: Terms such as “medium fat” or “low fat” must be defined with a
percentage.
4. “Standard diet” is a term often used in drug studies and it is too vague to be useful as it
can mean different things (regular or special). “Standard diets” need to be clarified
with the dietitian. The most effective time to do this is before submission to the IRB.
**PLEASE NOTE: Arrangements for all meals and/or snacks whether regular or special
must be captured on the service request form included in your IRB submission. If you
would like assistance, one of our registered dietitians would be happy to help you assess
your study needs.
During the study, in the event a special accommodation is requested (vegan, celiac, etc.)
which requires revised menu creation, special order food items or new analysis by a
dietitian; this would be considered “out of scope” and will incur additional charges that
will be estimated prior to work being performed.
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Meal passes are an alternate option to DCRU provided meals. They can be obtained by your
study team from Duke Hospitals’ contract food service company at varying amounts. Study
teams must arrange for meal passes; the DCRU does not arrange for these. Meal passes can be
used at any DUMC gift shop and food service.
**Please note; meal passes must be acquired in advance so if this is an option you wish to
explore please plan ahead.
Subjects not confined and have no dietary restrictions for study purposes, and / or any
person(s) accompanying the subject, are welcome to visit the food court located in the “B” level
of Duke South where they will find a variety of dining options which include:
1. Chick–fil-a
2. Subway
3. Seattle’s best Coffee
4. Grab and Go
5. Chop’d and top’d
6. Vending machines (located behind the food court)
The gift shop, located on the first floor of Duke South, also has a selection of sandwiches,
salads, desserts, and beverages.
For subjects and / or accompanying persons, interested in finding an eatery outside of the
hospital setting, the Information Desk on the 1st floor Blue Zone has publications with local
restaurants.
If you have any questions or would like further information please contact the Investigator
Advocate at 919-684-9966 or via e-mail at donna.hamel@duke.edu
If would like to consult a dietitian, please contact:
Catherine Gang at 919-930-5650 or via e-mail at Catherine.gang@ duke.edu
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Pulmonary Function laboratory Services
The DCRU is proud to be able to offer state of the art pulmonary function services to our valued partners
in clinical research. The following services are available to meet your study needs:
Spirometry
Bronchodilator administration
Single-Breath carbon monoxide diffusing capacity (DLCO2)
Measurement of lung volume
6 minute walk test
Body plethsmography
Methocholine challenge testing
Arterial blood gas sampling
The PFT lab is conveniently located at Duke South on the third floor in our research unit. The PFT
laboratory is staffed Monday through Friday 0800 – 1700. Subject testing must be scheduled to start by
1530 in order to assure adequate time to complete the testing prior to 1700.
For more information or to schedule a meeting to discuss how we can be of service to you, please call
the DCRU Investigator Advocate, Donna Hamel, at 919-684-9966 or via e-mail: donna.hamel@duke.edu.
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Recruitment Services
The DCRU has a Research Participant Recruitment Core (RPRC) that can assist with recruitment of
research participants. Recruitment services available include:
Evaluating Enrollment Feasibility for Proposed Protocols
During the evaluation of enrollment feasibility stage, the Duke Enterprise Data Unified Content Explorer
(DEDUCE) is used to evaluate potential participant population pools by querying electronic health
records. In addition to DEDUCE, the RPRC can access and query its in-house Research Participant
Volunteer Registry. The registry is an IRB-approved protocol that allows participants to consent to being
contacted for future research studies, giving us a ready pool of potential participants available for
contact early in the recruitment process.
Establishing Realistic Enrollment Targets
It is important to establish realistic targets early in the start-up process. Using a Funnel Analysis as a
guide, we estimate the necessary number of contacts needed in order to meet enrollment targets. You
can access our self-service tool to estimate the likely number of participants needed monthly in order to
obtain enrollment goals based on the available pool.
Understanding the PROCESS of Subject Participation
The "Leaky Pipe" or Recruitment Funnel Analogy
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Developing Study-Specific Recruitment Plans and Campaigns
The Core staff has expertise in determining the best strategies for recruitment based on information
gained during the feasibility process and understanding the study population. Staff will emphasize the
appropriate communication medium for the target population, some of which may be broadcast and/or
digital media, social media, directed letters, or campus contact. Staff may also utilize
ResearchMatch.org, a web resource dedicated to bringing together those looking for research studies
and research teams. For further information, please take a look at a Recruitment Action Plan (RAP) used
for a study conducted at the DCRU.
Managing the Recruitment and Enrollment Process
Upon IRB approval of a study, Core staff will begin implementation of the RAP and monitor enrollment
progress periodically throughout the study period. Core staff can also help manage the
recruitment/enrollment process by placing phone calls, receiving incoming calls resulting from the
advertising campaigns, prescreening potential participants, and scheduling appointments with potential
participants. In addition, they will analyze pre-screen and screen failures to determine if changes in
recruitment strategy are needed. The enrollment process will be monitored and Core staff will
communicate with study teams regularly in order to help the study stay on track. If necessary, Core staff
can help formulate contingency plans to get enrollment back on schedule.
Four Service Levels Available
Level 1
 Develop posters, flyers
 Develop and place online web ads (dukehealth.org, facebook, twitter, craig's list, free online
postings)
Level 2
 Develop print media ads
 Develop and place radio ads, advise on stations, support
 Develop television commercials, advise appropriate stations, air schedule, support
Level 3
 Consult protocol feasibility
 Manage call campaign
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 Develop Recruitment Action Plan (RAP)
 Registry Query
 Develop prescreening tools for IRB submission
Level 4
 Implement RAP
 Telephone prescreening
 DEDUCE query
 Identify clinic locations/providers with population
 Chart reviews/referrals
Contact
For more information or to request a consultation, please download and email a consultation request
form to dcrurecruit@duke.edu or call Lucian Cappoli at 919-684-4888.
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Study Plan Instructions
Study plan(s) provide the DCRU study team with the detailed work instructions necessary to
assure the conduct of your study is done in compliance with your IRB approved protocol and ICF.
Additionally, the study plan(s) serve as a physician order set which allows our staff to carry out
study specific tasks. The study plan(s) also serve as a source document for your subject’s study
visit. A finalized copy of the study plan will be kept on file at the DCRU to serve as a reference
source for study personnel. It is for these reasons; your study team is required to create study
plan(s) when utilizing the DCRU for the conduct of your study.
Careful creation of the study plan(s) will ensure that all the data required for your study will be
outlined; thus reducing the risk of missed data and protocol deviations. Additionally, well
prepared study plan(s) will lessen the amount of time required of you for clarification and
editing during the conduct of the study.
The following information will assist you in your creation and use of the study plan(s).
1.0 Study plan development: (Please see attached study plan sample on pages 17-21.)
Standardized forms:
Some studies require study plans to be placed in medical records. Medical records
require the use of form MO345. We realize your study may not require you to submit your
study plans to medical records; however, the DCRU requires the use of MO345 forms to
standardize study plan formatting.
Visit specific information:
1. Visit date (dd mmm yyyy)
2. Time of visit (24 hour format)
3. Type of visit (example: confinement, admission, outpatient screening, outpatient follow
up)
Study Identification:
1.
2.
3.
4.
5.
6.
Study title
IRB#
DCRU#
PI name
Subject #
Visit # (example: visit 2 or day 3 etc.)
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Subject identification:
1. Name
2. MRN
3. DOB: ddmmmyyyy
4. Physician /PI
EXAMPLE:
Body of study plan:
1.
2.
3.
4.
5.
Arrival time (use 24 hour clock)
Consent status and date of consent
Study team contact info
Emergency contact info
Study procedures being done on the DCRU
a. In sequential order
i. Each procedure should be in a separate block on the study plan. Details
concerning that specific procedure can be placed in the same block (i.e.
all labs can be in the same block but the ECG should be in a separate
block).
b. For each procedure denote if DCRU staff or PI study team will be performing the
procedure.
c. Provide enough detail about procedure to ensure procedures are carried out per
protocol
i. Example: Vital signs: have subject supine for 5 minutes prior to obtaining
d. If specific time points necessary (example study drug admin @ 0800)
e. Line for actual time of procedure if time sensitive (example:. blood draw or drug
administration)
f. Area for initials of whomever performed the specific task (at specific task line)
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Example:
6. LABS: The DCRU laboratory relies completely on study plans to provide instructions
about collecting and processing laboratory samples. The laboratory section of the study
plan must contain the following information:
i. Where the supplies for this visit are (provided by study team, kits or
supplies stored on DCRU)
ii. The tests being requested
iii. The tube volume and type needed for the test
iv. The lab that will perform the test
v. Any special conditions required (collect on ice)
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vi. How the samples is to be processes (this can refer to a core lab provided
manual)
Example 1:
Obtain blood sample using the Covance Visit Kit provided on DCRU. Refer to the Covance
Laboratory Manual for processing instructions.
Test
Sample Requirement
Lab
Chemistry Panel/GFR
4.5 ml SST tube
Covance
Uric Acid
2.5 ml SST tube
Covance
PK sample
4.0ml EDTA tube (place immediately on ice) Covance
Serum Pregnancy
3.5 ml PST tube
Duke Labs
Example 2:
Use tubes provided by PI at time of visit
TEST
Sample Requirement
Lab
PK sample
6 ml EDTA on ice
DCRU
Pre-cooled, labeled tubes to be provided by Investigator
Chemistry
8.5ml SST tune
Labcorp
Hematology
4.0 ml EDTA tube (lavender top) Labcorp
PK sample Processing Instructions
1. Blood samples will be obtained in pre-cooled 6 ml EDTA tubes.
2. After collection, place sample in an ice bath, or refrigerate until sample is processed.
3. Samples should be processed as soon as possible, within 60 minutes of collection, at
2000 rpm at 4° C for 10 minutes.
4. Transfer plasma into pre cooled, labeled polypropylene tubes.
5. Transfer a minimum of 1.5 ml into the 1st aliquot tube.
6. Transfer any remaining plasma into the 2nd aliquot tube.
7. Freeze in an upright position at -20° C.
8. Tubes should be labeled with study #, study visit, subject #, sampling time point,
aliquot/tube number & matrix.
For Labcorp samples please refer to the Labcorp manual/instructions provided
Hints for Success:
The more specific you are – the better chance you have of getting what you want.
If you say make 3 aliquots – you will get 3 equal volume aliquots, even if there is very little
serum – you will get 3 very little aliquots. If you say create 3 aliquots with at least 0.5ml in the
first aliquot. You will get something very different.
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If you say hold for pick up by investigator team – the tubes will sit on the bench until someone
comes for them. If you say store samples refrigerated in an upright position – the samples will
be placed in a rack at 4 degrees until someone comes for them.
Be careful using top color to define what tube to use – green top tubes can be sodium heparin
or lithium heparin.
When defining time points, be specific – if you say draw 1 hour post infusion – is that from the
start or end of the infusion?
For additional information please refer to the laboratory services information sheet
7. Nutrition services:
i. Denote if meals / snacks are required during visit
ii. Specify if study specific dietary requirements exist
1. If protocol specific meals are required , please contact Nutrition
services @ 919.668.2251 prior to study start up
iii. Specify timing of meals / snacks if protocol specific (example: fasting from
___ to ____, or restricted one hour prior to dosing etc.)
iv. If no protocol specific meals / snacks or timing is required, the DCRU
standard menu will be used however; place meal / snack in body of study
plan in appropriate sequential order with other procedures
For additional information please refer to the nutrition services information sheet
8. Discharge instructions (including date and time of next scheduled visit)
Example:
Signature lines:
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Since all sections are initialed by the personnel performing the specified task, an area for the
corresponding signature should be provided at the end of the study plan.
Example:
Footer:
1. PI signature and date line
2. Version date and #
a. Date should be formatted as: dd Mon YYYY followed by the version number
formatted as v#
i. Example: 23 Jun 2011_v2
3. Number the pages
a. Use the page x of y format so the DCRU study team will be aware if a page is
missing. This will alleviate missing data due to the missing data sheets.
Example:
2.0 Use of the study plan(s) during the conduct of your study:
Prior to scheduled visit
At least 48 hours prior to your subjects scheduled arrival for their DCRU visit, a study plan for
that specific subject and visit must be submitted. This allows the DCRU team to make any
necessary preparations for the visit thus alleviating unnecessary ‘wait’ time for your subjects
and your study team.
The following sections of the study plan must be completed prior to submitting a study plan for
a scheduled visit:
1. Visit specific information
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Form
DUKE UNIVERSITY MEDICAL CENTER
M0345
2.
3.
4.
5.
Study identification
Subject identification
Numbers 1 – 4 as well of the body of study plan section
The PI’s signature & the date on the designated line
a. Our nursing staff must have a PI signature in order to
perform study procedures. If your study plan does not
have the PI signature and date, we will not be able to
perform your study procedures.
If your study requires more than one visit on the DCRU, a visit specific study plan for each visit
will be needed (even for lab only visits). Each subject will need their own set of study plans. Once
the necessary information has been added to the study plan it can be submitted with your
schedule request via e-mail to DCRUsched.
3.0 Conclusion of visit:
Once your subject’s visit has concluded, the study plan is taken to the receptionist area located
on 3N. You may pick up the study plan from the receptionist who will ask you to sign a form
indicating that you are now in possession of the study plan. This process must be followed even
if you are the last person to work with the study plan for that visit. Adherence to this process
provides study teams with assurance that their source documents are accounted for.
We do not make copies of the completed study plans, nor do we submit outpatient visit study
plans to medical records therefore; accurate accountability is a must.
4.0 Amendments or modifications
If your study plan needs any modification (i.e. amendment, clarification etc.) please make the
adjustments and submit a revised copy, with an updated version date, to the Investigator
Advocate. This copy will replace the prior version in the DCRU records.
If you have any questions, concerns, or would like further assistance please contact the DCRU
Nurse Manager, Kim DeBaun @919.684.1780
The following study plan is an example of a clear and concise document.
Patient:
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Protocol title
History #:
Date of Birth:
Physician:
Date:
DCRU#: XXXX
eIRB #: Pro000xxxxx
Subject #:
Staff Initials
1. Subject to report to DCRU at
(use 24hr time format).
2. Study contact: CRC____________ @ ___________
CRC____________@ ____________
Emergency contact: (PI, CRC, MD etc) ____________@__________
3. Informed consent to be obtained by study coordinator prior to any
procedures.
Informed consent signed _____/_____/_____at:_____:_____.
4. DCRU: Obtain the following laboratory tests: *DHIS Requisition
required*.
TEST
SAMPLE REQUIRMENT
LAB
*β-HCG - Quant 4.5 ml plasma separator tube RRL-STAT
(Do Only If Checked)
**If β-HCG needed, obtain all laboratory tests at this time*****
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5. DCRU: Obtain vital signs: Time __ __: __ __(use 24-hour clock).
Weight ____________ (Kg) (no shoes)
Height_____________(cm) (no shoes)
Temperature__________C°.
Pulse
______________
RR
__________.
BP________/_______(mmHg)
*Please have subject sit quietly for 5 minutes prior to vital signs
measurement.
Measure BP with subject’s arm resting on a table at level of heart.
6. DCRU: Collect demographics: DOB:_____/_____/_____
Gender: Male Female
Ethnicity:
 1. Hispanic or Latino
 2. Not Hispanic or Latino
 3. Not Available
Race:
 1. American Indian or Alaska Native
 2. Asian
 3. Black or African American
 4. Native Hawaiian or Other Pacific Islander
 5. White
 6. Not Available.
7. Study team: Review inclusion / exclusion criteria

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Met inclusion criteria
 Subject excluded
Page 22 of 35
8. Obtain the following laboratory tests: Use ONLY the Covance Screening
Visit Kit Provided including the 21g Butterfly Set.
Refer to Covance Laboratory Manual for Processing Instructions
TEST
SM4/PD
SM6/RNA Paxgene
Hematology Panel
SAMPLE REQUIRMENT
8.5 ml BD P100 tube
(Protect from light)
2.5 ml Paxgene tube
3 ml Lavender top tube
LAB
DCRU
DCRU
DCRU
Chemistry Panel
3.5 ml SST tube
DCRU
_____ Do Only If Checked
Add Serum Beta hCG - Qualitative to Covance Requisition
Total IGE
2.5 ml SST tube
DCRU
SM5/PD
10 ml Red/Grey top tube
DCRU
Urinalysis
Minimum volume 12 ml’s
DCRU
9. DCRU: Review concomitant medications
10. Study team: Review medical history
11. DCRU: Obtain 12 lead ECG via DUMC study machine (Mortara ELI
2000). Perform after
Subject has rested quietly for at least 10 minutes in the supine position.
*Set time in ECG machine to reflect local time before recording
subject ECG.
*Use internal clock from ECG machine to document time.
Time of ECG:_____:_____ (study coordinator to attach report)
Normal:________ Abnormal:________ (clinically significant/ not
clinically significant)
1
112. Physician to perform physical exam.(Dr. John Smith –xxx-xxxx,
page-xxx-xxxx or Dr. John Doe- xxx-xxxx, page – xxx-xxxx)
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13. CXR done within 2 years: NO
YES
_______ If YES, subject to provide copy of results
_______ Sign medical release form to obtain report from primary
care facility.
_______If NO obtain CXR *Perform ONLY AFTER NEGATIVE
-HCG. (V70.7 Study Protocol, Dr. Sundy)
14. DCRU: monitor for any AEs occurring during or immediately following
any screening procedures.*
* Please have PI (Dr. John Smith) or his designee evaluate any AEs
for causality.*
* see attached AE evaluation form
15. End of visit procedures – Study team:
a. Confirm visit 2 appointment if applicable
Date-_____________Time-____________
c. Provide Subject appropriate instruction sheet _______
d. Discharge subject
______
e. Enter subject into sponsor screening & enrollment log _________
f. Enter subject in eResearch ______
Signature Log:
Initials
Signature
_____
________________________________
_____
________________________________
_____
________________________________
_____
________________________________
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Scheduling a subject visit
The Duke Clinical Research Unit is fully staffed for your research needs Monday through Friday 0700
through 1900. Our unit is operational during ‘off’ hours (i.e. evenings, nights, and weekends) when
needed, however; ‘off’ hours are staffed according to need therefore advance notice is required. In an
effort to assure that the appropriate staff is available to assist in the conduct of your study, for those
‘off’ hour needs you will be asked to contact our Nurse Manager, Kim DeBaun, via e-mail
(Kim.Debaun@duke.edu) or phone (919-684-1780) for prior planning / approval. It is important that you
notify DCRU Nurse Manager as soon as you become aware of the need for an ‘off’ hour visit. It is easier
to cancel a scheduled visit than to attempt to get the appropriate staff with only a few days’ notice. All
visits can be made far in advance. We can schedule your subject’s visit as far in advance as one year.
The DCRU provides a scheduling request form to assist with your scheduling needs. A sample schedule
request form is located at the end of this section. You can request a schedule request form be sent
electronically by e-mailing the Investigator Advocate, Donna Hamel, at donna@hamel.duke.edu. Study
visits cannot be scheduled until a schedule request form has been submitted.
The first step in filling out the schedule form is determining what type of admission status your subject
needs. Based on this determination, our staff will be able to schedule your subject to be seen at the
appropriate location on our unit.
The schedule form: A separate schedule form must be used for each protocol. However; one schedule
form can be used to schedule multiple visits for a single subject or multiple subjects for multiple visits as
long as all visits and all subjects are being scheduled for the same protocol.
Schedule form completion:
1.
Protocol information – In the upper right hand corner you will see prompts for information
a.
PI – insert the name of the principle investigator as listed on the IRB
b.
DCRU# - insert the DCRU protocol # assigned for your study (ex. SL09)
c.
Scheduled by – Insert the name and phone # of the person completing the form
i.
This provides DCRU scheduler with contact information should a question arise.
d.
IRB # - Insert the number assigned to your protocol by the IRB
2.
Schedule form body – It is important to complete all sections.
a.
Name – enter the subject’s last name followed by comma followed by first name
i.
Nicknames should not be used as we use IDX for scheduling and names must match their
medical record number
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b.
MRN – enter the subject’s medical record number
i.
If your subject does not already have a Duke medical history number please indicate ‘new’ and
the DCRU health unit coordinator will work with medical records to create a medical history number for
your subject.
c.
DOB – enter month, date, and year of birth
d.
Address – enter the subject’s address including zip code
e.
Phone number – enter subject’s phone number including area code
f.
Visit Date – enter the date, month, day, and year, you wish to conduct your visit
g.
Visit Time – enter the time you want your subject to arrive at DCRU
i.
Any time after noon should be submitted in 24 hour format (e.g. 1500)
h.
Expected length of visit
i.
Enter the approximate amount of time in hours you expect your subject to be on the DCRU
ii.
If your protocol requires your subject to leave the unit and return following a procedure please
state this in the comment section of the form
i.
Admission Status - There are three options for visit status’ The status of the visit you need
determines which steps will be necessary when the DCRU staff is preparing for your subject’s visit.
i.
There is a drop down menu from which you can select either:
1.
Outpatient
2.
Inpatient
3.
Confinement
The following will provide you with the information you will need when determining which status of visit
is needed:
Outpatient – Outpatient status is selected for visits lasting no more than 12hours in duration.
Outpatient visits can occur either during regular business hours or during ‘off hours’. To schedule an
outpatient visit:
a.
During regular business hours - simply submit your schedule form
b.
During ‘off’ hours - you must first contact the DCRU Nurse Manager, Kim DeBaun, via e-mail
(Kim.Debaun@duke.edu) or phone (919-684-1780)for prior approval.
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Inpatient – Inpatient status is selected for visits in which your subject will require standard of care
services in conjunction with study procedures, and will require more than 12 hours on our unit. For
example: an oncology study requiring study procedures and a procedure that will be included in the
medical record and billed to insurance. These visits are viewed as a hospital admission.
c.
During regular business hours - simply submit your schedule form
d.
During ‘off’ hours - you must first contact the DCRU Nurse Manager (Kim DeBaun @ 919-6841780 or Kim.debaun@duke.edu for prior approval.
Inpatient visits require the study team to complete an additional step. The study
team must have the subject’s admission process completed prior to subject arrival at DCRU. To have
your subject/patient pre-admitted, you will need to contact hospital admissions at 919-681-2002. They
will provide you with an admission form. Once you complete the form you will need to fax it to bed
reservations at 919-684-5041. You should then confirm admission status by contacting bed reservations
at 919-861-4300.
This is a vital step as we DCRU is not able to arrive a subject/patient as an inpatient without this step.
What this means for you and your subject is, no procedures / orders can be seen in Maestro and no lab
requisitions will print.
The DCRU currently is not able to do this step for you in the event you somehow missed this step. It is
not that we do not want to help, we simply are not able.
Confinement – Confinement status is selected for extended stay visits (greater than 12 hours) in which
all activities are study related.
e.
For all confinement visits, you must first contact the DCRU Nurse Manager (Kim DeBaun @ 919684-1780 or Kim.DeBaun@duke.edu for prior approval.
j.
Visit ID / #
i.
Enter the protocol specified visit. For example; Screening, V1, C1D26. This will allow the DCRU
staff to prepare for the specific procedures needed for that specific visit.
k.
Study plan submitted
i.
Enter the date the study plan was submitted. Study plans must be submitted either prior to or
when the visit is scheduled unless prior approval has been granted by the Investigator Advocate.
l.
Special considerations / Comments – This is a free text area in which you can provide any
information you feel would be helpful when the DCRU staff is preparing for your subject’s visit. For
example; lab only, lab drop off, home meds etc.
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Schedule form submission: Once you have completed the schedule form, please send it to
DCRUSched@notes.duke.edu. The schedule form can also be faxed to 919-684-1674, however; it is
important that you notify the Health Unit Coordinator (919-684-1672) prior to faxing.
Once the schedule form has been received by DCRU, Health Unit Coordinator will process the
appointments in IDX. After the appointment has been scheduled, the subject will receive an on-line or
phone message to remind them about the appointment.
Cancellations / reschedules: Should you need to cancel a scheduled visit, please indicate on the original
schedule form and submit the edited form. To make the change on the form, simply put a strike through
the entire row of the visit you re cancelling. If you are re-scheduling you can add the rescheduling
information to the same form by adding the information to a new line.
Subject arrival: When your subject arrives at the DCRU for their scheduled visit, they will come to the
reception/waiting area where they will be asked to sign in. Once your subject has signed in, the DCRU
nurse and/ or a member of your study team will be notified of their arrival. Please note that scheduling
an appointment for research pulmonary function testing is done in addition to scheduling your subject
visit. For further instruction please refer to page 26.
As always, if you have any questions or concerns please contact the Investigator Advocate, Donna Hamel
@ 919-684-9966 or donna.hamel@duke.edu.
SAMPLE SCHEDULE REQUEST FORM
PI:
Duke Clinical Research Unit Schedule Form
Email to: DCRUSched
Name
MRN
Reception contact: 919-684-1672
DOB
Gender
Address
Phone
Number
1 SCHEDULE SHEET = 1 PROTOCOL
Visit
Date
Visit
Time
Expected
Length of
Visit/Hrs.
Admission
Status
Confinement
31 July 2014 v 1.7
DCRU #:
IRB#:
Contact #:
Sched By:
Page 28 of 35
Visit number
Version 2_06Sep11
Date Study
Plan
Submitted
Special
Considerations/
Comments
Pulmonary Function Testing Laboratory Scheduling instructions
To schedule your subject for pulmonary function testing, we ask that you fill out a PFT schedule
request form and submit it to the e-mail address listed on the form. There is no need to attach
a study plan with this request. This form has been designed with ease of use in mind as we
know how busy you all are and do not want to unnecessarily add to your burden.
Please use one form for each subject. The form includes easy following instructions for use and
submission, as well as contacting information should you like further instruction. You will notice
there is no 6 minute walk test option on this form. The 6 minute walk test will be part of your
regular scheduling and will be conducted by DCRU research nurses who have been specifically
trained for this procedure.
For any questions regarding the scheduling of pulmonary function testing for your research
subject, please contact Janice Hogan at 919-668-2262 or via e-mail at Janice.hogan@duke.edu.
Please note: This process DOES NOT replace the need to submit a DCRU schedule request form
for your DCRU study visit along with a corresponding study plan. That process is unchanged.
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Sample PFT lab scheduling form
Please complete the following including the estimated length of time your subject will be receiving the PFT
services portion of their visit. (Please refer to estimated times / procedure listed below)
Subject Information
Subject Name
MRN
DCRU#
Visit #
Requested Visit
Date
PFT lab visit
time
(time subject
will report to
PFT lab)
Expected
Length of
Visit
(PFT portion
only)
Please place a check in the box (s) indicating which services you are requesting for this subject at this visit
 if
requested
Services requested at this visit
Estimated time
Simple Spirometry
40 minutes
Spirometry with DLCO
70 minutes
Spirometry with MVV
60 minutes
Spirometry with body plethsmography
70 minutes
Spirometry with DLCO, MVV, and body plethsmography
90 minutes
Bronchodilator administration (metered dose inhaler)
10 minutes
Pre & Post bronchodilator spirometry
90 minutes
Methacholine challenge (bronchoprovocation)
3 hours
Arterial Blood Gas sampling
30 minutes
eNO
10 minutes
Requested by: _________________________________ Contact # _______________
Please send completed form to (insert e-mail group address) for scheduling. In the
event your requested date / time is not available, you will be contacted as soon as
possible with alternate dates/ times available. You will receive a confirmation e-mail
once your subject visit has been scheduled.
The DCRU PFT scheduling administrator is Janice Hogan. She can be reached at
Janice.Hogan@duke.edu or by calling 919-668-2262 should you have any
questions concerning PFT scheduling.
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Pre – initiation Check List
In an effort to make sure your study runs smoothly, you will not be able to schedule any subject visits at
DCRU until the following have been completed and this checklist has been signed off by both a member
of your study team and the investigator advocate.
1. Partnership Agreement
 Service request form
Budget agreement
2. IRB
 Notify investigator advocate of IRB approval
3. Study plans
 Study plans submitted to investigator advocate for review
 Study plans approved
4. Laboratory services
 Supplies have been provided to DCRU laboratory services
 Laboratory manual / instruction sheet have been provided to DCRU laboratory
manager
 If utilizing a central lab, shipping instructions and supplies have been provided to
the DCRU laboratory manager
 A copy of contract if utilizing a non- duke laboratory
 N/A
5. Nutrition services
 Protocol specific diet menu completed and approved by DCRU nutrition services
manager
 N/A
6. Site initiation Visit (SIV) (study plans must be drafted prior to scheduling)
 Date: ____________ time:_____________
7. Scheduling
 Review of scheduling instructions
Investigator Advocate: ___________________________ Date: ______________
Study team representative: _______________________ Date: ______________
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Frequently asked questions
Topic: IRB
Question: My study team would like to use the DCRU services for an already approved protocol.
What do I need to do?
Answer: All aspects of research in humans must be approved by an IRB therefore; an IRB
amendment will be required. If you need assistance please contact the DCRU Investigator
Advocate, Donna Hamel @ 919-684-9966 or donna.hamel@duke.edu.
Topic: SIV (formally referred to as a protocol conference)
Question: What is an SIV?
Answer: The DCRU SIV is a short informal training session usually lasting an hour that must
occur prior to scheduling your first study subject. The SIV is scheduled by the contacting Kim
DeBaun, at Kim.Debaun@duke.edu or phone 919-684-1780. The SIV is led by your study team
and attended by the DCRU staff.
Question: What do I need to do for the SIV?
Answer: You will need to bring a copy of your study plan drafts, a synopsis of the study, and be
prepared to discuss both. This SIV is a forum in which the expectations of both teams, DCRU
and your study team, can discuss how the study needs to be conducted, who will be performing
each procedure, and any special considerations (ex: special needs populations, dietary
restrictions etc.).
Other considerations: You may want to bring along your training and delegation logs. Most
studies require training documentation as well as signed delegation logs. The protocol
conference is a good place to obtain staff signatures for your delegation log as well as training
logs since this is a training session.
Topic: Electrocardiograms
Question: My study requires ECGs. Can the DCRU use a sponsor supplied ECG machine?
Answer: Yes. While the DCRU does have their own machines, it is quite common for Industry
Sponsors to provide and require the use of their own machines.
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Other considerations: Frequently sponsors will ask for training documentation for the staff
performing the ECG. The DCRU staff will attend a training session at your request and provided
by your study team. This can often be accomplished during your DCRU site initiation visit.
Question: Can the DCRU staff transmit the completed ECG to the specified vendor?
Answer: The DCRU staff is happy to transmit your ECG, however, you must provide specific
instructions for transmitting either on the ECG machine itself or in the study plan ECG section.
Question: Will someone from the DCRU interpret my ECG?
Answer: No. We do not currently offer that service. You will need to make arrangements to
have the ECG tracing read.
Other considerations: In the event you need a reading for all your tracing you may want to
consider contacting the Heart Station. However, the Heart Station will only use their own
machines so if you need to use a sponsor supplied machine, they may not be able to help you.
Topic: Study Equipment
Question: I know that the DCRU has their own equipment but my study sponsor requires the
use of sponsor provided equipment. Can there equipment be used on the DCRU and by the
DCRU staff?
Answer: Yes and Yes. The use of equipment sponsor provided equipment on our unit is
permitted however; the study team is responsible to make sure it is maintained in good
working order and within calibration (if applicable) or it cannot be used. In the event the DCRU
research team is asked to use Non – DCRU equipment they make an assessment to assure the
equipment has been maintained in good working and within calibration (if applicable and
calibration records are readily available) . Any equipment deemed in less than good working
order or not within calibration will be reported to the study team and will not be used until the
equipment until it is brought into compliance.
Other considerations: Frequently sponsors will ask for training documentation for the staff using
their required equipment. The DCRU staff will attend a training session at your request and
provided by your study team. This can often be accomplished during your DCRU site initiation
visit.
Question: Topic: Laboratory services
Question: My protocol requires processing PBMCs. Does DCRU provide this service?
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Answer: The DCRU does not currently provide this service. If your protocol requires PBMC
processing you will have to make arrangement with an outside entity. Contact the DCRU
Investigator Advocate who may be able to provide you with a contact.
Questions: Will the DCRU lab analyze my specimens?
Answer: The DCRU lab is a processing lab only. We do not perform analysis on any specimens
with the exception of certain point of care tests. For specific point of care test questions please
contact the DCRU the DCRU Investigator Advocate for any questions.
Question: If the DCRU lab does not analyze my sample, who does?
Answer: It is up to your study team to choose a vendor for analyzing your samples. You can
contact the DCRU Investigator Advocate for suggestions.
Question: I have Lab kits supplied by my sponsor; can I store them on the DCRU?
Answer: Yes, once you have had your protocol conference you can store your supplies on the
unit. Please contact our lab manager, Lynn Jordan, (919-668-3033) for specific information.
Question: I need laboratory supplies; where can I get these?
Answer: Please contact the the Laboratory Manager, Lynn JOrdan for suggested vendors.
Important considerations: All lab results analyzed through the DUHS system become part of the
subject’s medical record and therefore are not de-identified. If you are using an external lab for
analysis, arrangements for the DCRU staff to process and ship can be made however; it is
important to note; the DCRU staff will use the shipping information and specimen labels
provided by the vendor which may or may not ask for identifiers such as name and date of birth.
If you do not want identifiers on your samples you will need to make this clear to your vendor.
The DCRU is not involved in your agreements and therefore; will use the lab manuals, labels, and
instructions provided by you or the vendor on your behalf.
Topic: Pharmacy
Question: Does DCRU provide investigational pharmacy services?
Answer: The DCRU does not currently offer investigational pharmacy services. You will need to
contact the DUHS Investigational Drug Service for your pharmacy needs.
Question: My subject is being admitted to DCRU 2N takes medication(s) at home in addition to
the investigational product, can subjects use their home medications?
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Answer: Subjects are permitted to bring in home medications for use on the DCRU with prior
approval. There are specific procedures and requirements in place to assure all regulatory
requirements are met and more importantly to assure subject safety. (SEE Page 6; DCRU
pharmacy services inpatient section)
Topic: DCRU access
Question: I am enrolling subjects on the DCRU but I cannot get into the unit without being ‘let’
in. Is there any way I can gain access?
Answer: The DCRU is a closed unit. Badge Access is granted based on a needs assessment. If you
would like to request badge access, please contact the DCRU Investigator Advocate.
Topic: Inpatient admissions
Question: If my subject is to be admitted as an inpatient, who is responsible for the inpatient
admission process?
Answer: It is the responsibility of the study team to make these arrangements) please see
scheduling section page 27). The DCRU currently is not able to do this step for you. It is not that we do
not want to help, we simply are not able.
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