General Clinical Research Center
University of California, Davis
Sacramento VA Medical Center
GCRC
INVESTIGATOR
MANUAL
INDEX
PAGE
MISSION STATEMENT
3
RESOURCES
Clinical Resources
4
Program Direction
6
Administrative Resources
7
Core Laboratory
8
Research Subject Advocate
10
PREPARATIONS TO INITIATE A GCRC STUDY
Required Documents
11
Protocol Initiation Meeting
11
Protocol Initiation Policy
13
Drafting Orders and Developing Flowsheets
15
Examples of Orders and Flowsheets
15
Pharmacy
24
Research Related Equipment Approvals
25
ADMISSION PROCEDURES
Scheduling
26
Patient Care Information
26
Terms and Conditions and Notice of Privacy Practices
27
MEDICAL RECORD MANAGEMANT
28
2
MISSION STATEMENT
The mission of the General Clinical Research Center is to provide a central resource to
facilitate clinical research and to serve a mentoring function in patient-oriented research for
investigators at the VA Northern California Health Care System and University of California
Davis. The GCRC will strive to promote the highest standards in clinical research, will ensure
that patient safety aspects are appropriately addressed and will provide the resources necessary
for investigators to conduct clinical studies. It will provide a center facility to promote mentoring
of young clinical investigators, and will serve as a focus for education initiatives related to
patient-oriented research.
3
RESOURCES
CLINICAL RESOURCES
1. Nine outpatient beds are located on the 4th Floor of the Sacramento VA Medical Center. Rooms 19, 23,
and 25 are semi-private. Rooms 29, 31, and 39 are private. One of the private rooms can be utilized as
a positive pressure isolation room and/or procedure room and the two remaining private rooms are
specially designed viewing rooms. All of the rooms are equipped for the care of all research subjects.
Routine costs for these beds are fully paid for by the GCRC grant.
2. DEXA, PQCT, BOD POD, and Exercise machines are available.
3. Highly skilled and trained research nurses provide care on the unit 4 days/week. Special
accommodations can be arranged for evening and weekend hours.
4. Currently, three research RNs staff the outpatient unit. Hours of operation are 0700 to 1700 Monday
through Thursday.
5. Weekly operations meetings are conducted to discuss staffing and scheduling. Assurances are made to
provide adequate staffing for all studies, especially those requiring a patient to nursing ratio of 1:1.
6. Nursing staff is trained to perform the procedures listed below. Annual competency based training
ensures proficiency in these test procedures. Training for additional research specific procedures may
be added as new studies are initiated.
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Adverse Event Management
Central Line Access
Central Line Site Care
Chemotherapy Administration
Conscious Sedation
Continuous Insulin Infusion
Continuous Pulse and BP Monitoring
Draft Standing Orders with Physician
EKG
Flowsheet Design
Glucose Monitoring
Glucose Tolerance Test
Modified Fluid Deprivation/Waterload/Hypertonic Saline Infusion
Peripheral Line Access and Maintenance
Pharmacokinetic Studies
Pituitary Hormone Testing
Specimen Processing
7. Amenities
Directions: Preprinted directions are available to research teams to provide to their research
subjects. We encourage the use of these materials as subjects can easily get lost. Electronic
versions are also available.
Parking: Parking is free for all staff and subjects. Please be aware that the lots surrounding the
hospital fill up quickly after 9am. People arriving before 9am will have to walk a distance of
approximately 100 yards. Arriving after 9am may require a longer walk. A parking shuttle service is
If special accommodations need to be made for a particular subject, please see the Nurse Manager.
Closer parking can be reserved, but only for the neediest subjects.
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Contact Information:
UC Davis General Clinical Research Center
Sacramento VA Medical Center
10535 Hospital Way, 4th Floor
Mather, CA 95655
916-843-9429
Nicole Mullen, RN, BSN
Nurse Manager
916-843-9426 – office
916-843-9441 – fax
916-762-6109 – pager
NMullen@ucdavis.edu
Joe Ann Sheppard, RN, BSN
Clinical Research Nurse
916-843-9429
joeann.sheppard@ucdmc.ucdavis.edu
Cristine Lacerna, RN
Clinical Research Nurse
916-843-9429
cristine.lacerna@ucdmc.ucdavis.edu
5
GCRC PROGRAM DIRECTION
Lars Berglund, M.D., Ph.D. is the GCRC Program Director and is guided by the recommendations of the
GCRC Advisory Committee (GAC) and works closely with the Chair of the Committee to ensure appropriate
and effective use of GCRC resources. The Program Director carries out his responsibility within the
framework of existing policy and procedures of the University Medical Center and the Sacramento VAMC
and ensures that administrative, patient care and research reporting procedures are carried out in conformity
with NIH, UC, and VA policies. In his role as Program Director, he sets goals and standards for the GCRC,
encourages clinical investigators to utilize the GCRC and fosters collaborations between clinical and basic
investigators.
The Program Director and Associate Program Directors, Drs. Claire Pomeroy and David Asmuth, are
ultimately responsible for the care of all GCRC patients. However, every patient treated on the GCRC will be
cared for in a collaborative manner.
The GCRC team established for each patient treated on the unit consists of: the responsible physician
investigator, who may or may not be the Principal Investigator of each protocol; the GCRC nurse assigned to
the patient; staff nurses in the GCRC; and, in some cases, a research nurse or staff person supplied by the
Principal Investigator of the project.
The Principal Investigator for each study is responsible for establishing a plan of care and is responsible for
providing physician coverage of patients studied under his or her protocol. Non-physician principal
investigators are required to have a physician co-investigator or collaborator, and the collaborating physician
assumes direct responsibility for patient care. Fellows and/or house officers working with the principal
investigator may assist in the management of GCRC patients. The arrangement of medical coverage for
patients in any protocol will be the responsibility of the respective Principal Investigator. The Principal
Investigator may delegate the primary responsibility for care of a research participant to a resident or a
postdoctoral fellow, but he or she remains accountable. The physician providing coverage will be available in
person, by phone or pager 24 hours a day, seven days a week. If a study participant is admitted for a study
requiring overnight care, the responsible physician must be available during that participant’s stay on the
GCRC.
Contact Information:
Lars Berglund, MD, PhD
Program Director
Sac VAMC, 5th Floor
916-843-9435 – VA office
916-734-7504 – UCDMC office
916-762-7368 – Pager
lberglund@ucdavis.edu
Khatera Sahak
Administrative Assistant
Sac VAMC, 5th Floor
916-843-9438 – Office
916-843-9437 – Fax
khatera.sahak@ucdmc.ucdavis.edu
6
ADMINISTRATIVE RESOURCES
The GCRC administrative office is located on the 5th Floor of the Sacramento VA Medical Center.
Grant management and center administration on the GCRC is supported by the Administrative Director (AD)
and an administrative assistant.
Center administration for GCRC protocols includes:
¾
¾
¾
¾
GCRC application process
Budget and administrative review of GCRC application
Billing procedures, bill review and adjustments
Maintenance of records of IRB status of all GAC approved protocols
If an investigator wishes to apply to use GCRC resources, a GCRC application should be obtained from the
Administrative Director. The AD will gladly assist the investigator and/or the research coordinator with
questions regarding the application and the GCRC Advisory Committee (GAC) review process. The AD will
also review the application for format and budget concerns. Prior to initiating the study, all budget and billing
issues for procedures during the GCRC admission should be resolved and finalized. The GCRC utilizes
UCDHS patient registration, accounting, and billing mechanisms, and maintains records of all research
activity on the center. The GCRC grant guidelines describe three patient categories, which are used for all
research protocols. A general description of each category is found below, with the billing method usually
used. Questions regarding these categories should be directed to the Administrative Director.
Research Patients - Category ‘A’
Research inpatient days or outpatient visits in an investigator initiated study utilized solely for research
purposes. Usually, all patient care costs are the responsibility of the GCRC grant and the investigator’s
research funds, with the exception of some Medicare Qualifying Clinical Trials (MQCT) that bill routine care
charges.
¾ Some GCRC services are free of charge for approved ‘A’ studies
¾ Research activities and procedures not covered by GCRC funds will be charged to the investigator’s
research account.
Research Service Patients - Category ‘B’
Research inpatient days or outpatient visits that involve patients admitted for diagnosis or treatment based
on established standards of care. The GCRC or investigator is responsible for research-related charges,
while non-research care is billed to a third party carrier or the patient.
¾ Some GCRC services are free of charge for approved ‘B’ studies
¾ Research activities and procedures not covered by GCRC funds will be charged to the investigator’s
research account.
¾ Standard patient care activities will be billed to third party payor/patients.
Mixed Category ‘A’ and ‘B’
Occurs when the study structure indicates that some visits, or services are billed to the GCRC (the ‘A’
charges), while routine care charges are billed to insurance/third party payor. For example, the primary
reason for the visit/admission may be standard of care therapy with one additional research related activity (a
‘B’ visit), and there might be one follow-up visit/service solely for research purposes (an ‘A’ visit).
Industry-Initiated Projects - Category ‘D’
Inpatient days and outpatient visits utilized for an industry- initiated study. Usually, all charges are the
responsibility of the investigator and the sponsor.
¾ Billed directly to the investigator’s research account for the specific study.
7
Questions regarding any administrative, budget, or billing issues should be directed to the Administrative
Director.
Contact Information:
TBA
Administrative Director
Sac VAMC, 5th Floor
916-843-9436 – Office
916-843-9437 – Fax
Khatera Sahak
Administrative Assistant
Sac VAMC, 5th Floor
916-843-9438 – Office
916-843-9437 – Fax
khatera.sahak@ucdmc.ucdavis.edu
8
GCRC LABORATORY
The GCRC Laboratory is located at the GCRC, adjacent to the patient care area. The laboratory facility has
areas for specimen processing and analytical work as well as computer work stations for the technologists.
GCRC nurses are trained to perform basic specimen processing (centrifuging, aliquoting, and storing).
Complex processing is the responsibility of the study-specific research staff and can be arranged with the
Core Laboratory Directors.
Ishwarlal Jialal, MD and Sridevi Devaraj, PhD are the Laboratory Directors and questions regarding
laboratory services and capabilities should be directed to them.
Specimen Processing
The Core Laboratory can perform minimal to complex specimen processing. Among its services are:
- SOP’s for specimen processing are written to ensure that all specimens are collected and
processed in accordance with the approved instructions specific for each protocol
- single or multiple blood, serum, plasma or urine aliquots
- customized laser-printed labels specific for each protocol generated in-house
- access to one refrigerated centrifuge
- access to –20 and –70 freezers
- two refrigerators are available
- glucometer
Clinical Analysis
UCDHS Clinical Pathology Services is designated as the primary laboratory for routine analysis for the
GCRC.
The VAMC Clinical Lab will assist the GCRC in situations that require STAT lab results.
Specimen Storage
The Core Laboratory has access to a 4°C refrigerator, one upright –20°C and three -80°C freezers for short
term specimen storage.
All refrigerators and freezers are monitored daily for efficient and accurate temperature control.
Specimen Shipment
The PI and/or research staff are responsible for shipping specimens. Federal Express does a daily pick up
at the VAMC. GCRC nursing staff can direct research staff to the pick up location.
Research Staff are permitted to transport specimens off the VAMC property if they are certified to do so.
Copies of certifications should be given to the Nurse Manager. Medical Courier Incorporated provides
transportation of laboratory samples between the GCRC and labs off of the VAMC property as necessary.
Contact Information:
Ishwarlal Jialal, MD
Laboratory Director
ishwarlal.jialal@ucdmc.ucdavis.edu
Sridevi Devaraj, PhD
Analytical Lab Leader
sridevi.devaraj@ucdmc.ucdavis.edu
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RESEARCH SUBJECT ADVOCATE
The Research Subject Advocates (RSAs) reporting directly to the Principal Investigator, Dr. Joseph Silva, are
responsible for optimizing patient safety and providing assistance to GCRC study participants, investigators,
and staff in all aspects regarding protocol safety issues and compliance. The program ensures the ethical
conduct of GCRC studies through education, consultation, enhanced communication and coordination
among all members of the study team, implementation of policies and procedures, and oversight. The RSA
program also represents the interest of the research participants in the GCRC. The RSA program provides
an additional level of quality assurance for all GCRC protocols.
Ted Wun, M.D. is an Associate Professor of Medicine in the Division of Hematology and Oncology at UC
Davis and is the Chief, Section of Hematology and Oncology for the VA Northern California Health Care
System.
Sara Schmidt, Pharm.D. is a Research Pharmacist with the Department of Veterans Affairs Northern
California Health Care System and an Adjunct Clinical Professor for the School of Pharmacy, University of
the Pacific.. She is an active member of the VANCHCS IRB and the Adverse Event workgroup. In addition,
she is the Chair of the Pharmacy Quality Improvement Committee and a member of VANCHCS Bioethics
Committee.
Drs. Wun and Schmidt have a leading role to work with investigative groups on consent forms, subject safety
and adverse-event reporting issues, and for setting the groundwork for the IRB. As part of their routine
functions, the RSA has research subject safety responsibilities to:
1. Review all GCRC protocols prior to approval; guide and advise investigators in the development of
the Human Studies and DSMP elements of a protocol; and make recommendations to the GAC
regarding participant safety, compliance with all federal and other regulations, and ethics;
2. Review Data and Safety Monitoring Plans for each protocol to ensure accuracy and completeness,
and advise the GAC on the appropriateness of a DSMP to the protocol under discussion;
3. Review protocol consent forms to validate that they properly represent the risks and benefits for
the protocol and all research procedures
4. Audit protocols in progress to ensure that the DSMP is fully implemented; perform scheduled
external review of active protocols;
5. Work with the GAC, Dean Silva, Dr. Berglund and the protocol investigators to address immediate
issues as they arise in the conduct of the protocol; perform unscheduled, random protocol audits
to identify unexpected safety or data concerns;
6. Educate and train investigators and their staff with regard to human subject issues and good
clinical practice guideline.
Contact Information:
Sara Schmidt, PharmD
Research Subject Advocate
sara.schmidt@med.va.gov
925 372 2565 -- Office
925 943 4721 – Pager
Ted Wun, MD
Research Subject Advocate
theodore.wun@ucdmc.ucdavis.edu
916-734-3772 – UCD Office
916-843-7008 – VA Office
916-762-5803 – Pager
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PREPARATIONS TO INITIATE A GCRC STUDY
REQUIRED DOCUMENTS
There are several documents that are required before a protocol can be initiated on the GCRC.
a. GAC Approval: Any study initiated on the GCRC must have GCRC Advisory Committee (GAC)
approval. If the GAC has recommended revision of the protocol as conditional to approval, the
recommended revision(s) must be submitted and acknowledged as satisfactory by the GAC. The
GCRC Administrative Director advises the PI in writing the approvals, disapprovals, and/or
recommendations of the GAC.
b. Full IRB Approval: Before initiating a study, it must have full IRB approval for the protocol version, and
all current amendments, that is to be initiated by Committee A of the UC Davis IRB. A copy of the
IRB approval letter for the study, and a clean copy of all IRB stamped and dated Consent documents
must be received in the GCRC administrative office.
c. Human Subjects Protection Certification: In order to meet NIH requirements for training in human
subjects protection, all Principal Investigators and key personnel of GCRC supported projects must
complete the NIH web-based training module, and provide a copy of the certificate of completion to
the GCRC administrative office. The NIH module, “Human Participant Protections Education for
Research Teams” may be accessed at http://cme.nci.nih.gov. Description of this requirement may
also be found at http://www.ncrr.nih.gov/clinical/crwebcourse.htm.
d. Budget: If the final budget was not available at the time of GAC review and approval, a final budget
must be reviewed and approved by the Administrative Director. Significant budget changes not
discussed with the Administrative Director could result in a delay in the initiation of the study.
e. Bulk Research Account: A “90” research account number, specific to the study, must be established
prior to requesting a GCRC reservation for the first patient. The account number should be
communicated to the Nurse Manager.
f.
MQCT Information Form: If the protocol is a Medicare Qualifying Clinical Trial (MQCT), the
Administrative Director may request that an MQCT Information Form be submitted prior to the first
patient admission. This form is only required for studies that will bill routine care charges under
MQCT guidelines, and will be specifically requested if required.
Questions regarding required documents, assistance with clarification or additional information about the
application process should be directed to the Khatera Sahak.
PROTOCOL INITIATION MEETING
Prior to the initiation of any protocol, the investigator and/or research coordinator will meet with the GCRC
nursing staff to discuss the study’s goals and requirements. Representatives from the Lab and Kitchen are
encouraged to attend. Protocol-specific procedures, investigational drugs, specimen processing, and dietary
requirements will be discussed in detail. Standardized orders and protocol flow sheets must be approved by
the Nurse Manager prior to the first subject admission, and drafts of these documents will be reviewed at this
meeting. Notes of these meetings will be taken and placed in the protocol-specific folder.
To facilitate the implementation of each new protocol on the GCRC, a GCRC nurse assumes the role of a
Lead Nurse for the study to assist the PI in the planning and coordination of the study protocol and any
nursing or medical issues that may arise. In collaboration with the Nurse Manager, the Lead Nurse will be the
primary liaison to the Principal Investigator and/or any Research Coordinator involved in the study, and
GCRC Core Directors and staff. The Lead Nurse will also communicate with the RSA to ensure patient
safety. All GCRC staff nurses will assume the role of Lead Nurse as needed for new and ongoing GCRC
studies. The Nurse Manager will serve as mentor and preceptor for the clinical nurses who take on the
responsibilities of Lead Nurse for the first time. The Lead Nurse will review protocol design and will actively
cooperate with the PI to ensure that M.D. orders, necessary flow sheets and any participant information
11
material needed is developed. Thereafter the Lead Nurse will develop a study resource with key information
collected. The Lead Nurse will also act as a liaison with other GCRC nurses to ensure that all aspects of the
study design and all issues related to patient safety are addressed.
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UC Davis Health System
General Clinical Research Center
TITLE:
Protocol Initiation
PURPOSE:
To ensure precise and consistent implementation of research protocols
POLICY:
It is the policy of the GCRC that all research protocols will be implemented consistently
and precisely. To ensure precise and consistent implementation of research
procedures and data collection while providing for patient safety, the following process
should be respected:
1. Protocols requesting GCRC support must be submitted to and approved by the UCD IRB Committee
A and the GCRC Advisory Committee (GAC). The IRB and GAC protocol approval documentation is
required. The GCRC Administrative Director will facilitate IRB and GAC processes and issues.
2. To use the GCRC facility, the P.I. for the study, or alternatively a co-Investigator, must have a VA
appointment, with or without-compensation (WOC). WOC paperwork must be submitted for any
research personnel who do not have a VA appointment. This paperwork will be distributed by and
submitted to the GCRC Administrative Director.
3. Once the protocol is approved, it is the responsibility of the clinical study coordinator or principal
investigator to contact the GCRC Nurse Manager to arrange a protocol initiation meeting to discuss
implementation of the protocol. The GCRC Nurse Manager will thoroughly review the protocol and
determine the other appropriate GCRC research staff that needs to be involved with implementing the
protocol. These staff members are invited to the initiation meeting.
4. The Nurse Manager will need the following items before or at the Protocol Initiation Meeting:
a. Complete Approved Protocol
b. UCD IRB Currently Approved Consent
c. UCD IRB Approval Letter
d. GAC Approval Letter
e. Standardized Protocol Orders (draft acceptable)
f.
Study Specific Flowsheet (draft acceptable)
g. Specimen Collection and Processing Instructions (draft acceptable)
h. UCD Bulk Account Number
5. Any future IRB approved amendments to the protocol or consent must be submitted to the Nurse
Manager.
6. A GCRC nurse will be assigned the role of a Lead Nurse for the study to assist the PI in the planning
and coordination of the study protocol. In collaboration with the Nurse Manager, the Lead Nurse will
be the primary liaison to the Principal Investigator and/or any Research Coordinator involved in the
study, and GCRC Core Directors and staff.
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7. After the meeting and prior to protocol implementation, all study related services, documents, and
supplies required to properly implement the protocol must be in place. This process requires a
minimum of two weeks.
8. After the initiation meeting, the GCRC Lead Nurse assists the PI in developing the study specific
physician orders, protocol flowsheets, and documentation required to properly implement the study.
The orders are reviewed by the GCRC Nurse Manager, the clinical study coordinator and/or the
investigator, and then appropriately revised. Final Versions of the Standardized Orders, Flowsheets,
and Specimen Collection and Processing instructions should be complete within 10 of days of the first
subject appointment.
9. If the protocol requires medication administration, the GCRC Lead Nurse will assist the PI with
contacting the Investigational Pharmacists at UCDMC and the VAMC.
10. If the protocol calls for Clinical Lab support, the GCRC Lead Nurse will assist the PI with contacting
the Clinical Labs at the UCDMC and VAMC.
11. The GCRC Lead Nurse will assist in developing lab-processing guidelines.
12. The GCRC Lead Nurse will educate the appropriate GCRC research staff regarding the protocol and
its implementation procedures. Education is provided via inservices, demonstration, and
documentation in the protocol folder.
13. The GCRC Lead Nurse maintains contact with the clinical study coordinator and/or investigator
throughout the study to ensure positive outcomes.
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DRAFTING ORDERS AND DEVELOPING FLOWSHEETS
The principal investigator should prepare physician’s orders and, if needed, a flowsheet for the study.
These documents need to be approved by the Nurse Manager. Final versions of these documents
should be emailed to her at least 10 days before the scheduled first subject. It would be ideal if these
documents were completed prior to the Protocol Initiation meeting. Lead-time of at least one week prior to
an initiation inservice provides the nurses and related staff members the opportunity to review your
protocol, orders and flowsheets. Staff can then formulate questions prior to the actual inservice, so that all
issues may be resolved at that time.
Orders should be kept simple and straight forward, outlining what is to be done by the nurse (e.g. blood
draws, frequency of vital signs, diet and activity orders, medication administration, physicians to be
notified in case of emergency, study coordinator pager and / or phone numbers). If blood specimens are
to be drawn, please include the type of tube in which the specimen should be drawn, and any special
handling instructions (e.g. invert 6 times, place on ice, pre-chill tube). Also include which lab the
specimens are to be sent (UCDMC Clin Lab, GCRC Core Lab), or will be picked up by you or a designee.
If GCRC nurses will be doing specimen processing, these instructions need to be in the orders.
Orders should be printed out on blank white paper with the blue strip. It should have the GCRC header
and be formatted accordingly. An electronic template is available to the PI.
Flowsheets should be devised for studies when serial specimens are to be obtained, medications are to
be given, or procedures are to be performed at very specific time points over the course of the patient’s
visit. To be able to keep a well-devised flowsheet is an essential tool enabling all staff to easily determine
procedures at a glance. This minimizes the chance of mistakes and ensures that the study is run
properly and clean data is collected. It should have the GCRC header and be formatted accordingly. An
electronic template is available to the PI.
Once the orders and flowsheets have been revised and approved by the principal investigator and nurse
manager, they will be formatted onto Physician’s Orders Sheets. Each subject’s orders must be signed
and dated by the PI and received by the GCRC by the morning of the scheduled visit.
EXAMPLES OF ORDERS AND FLOWSHEETS
Following this section are examples of orders and flowsheets that have worked well.
Example A is a set of orders for a simple study that requires only a single blood draw. No flowsheet is
needed for this study.
Example B is a set of orders for a moderately complex study involving serial specimen collection over 12
hours, administration of study meals, and infusion. A flowsheet accompanies these orders.
Example C is a set of orders for a complex study multiple visits over a 3 year period. No flowsheet is
needed for this study.
Example D is a set of orders for moderately complex study involving drug administration and frequent
blood draws over 2 1/2hours. A flowsheet accompanies these orders.
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EXAMPLE A
Patient Plate
UNIVERSITY OF CALIFORNIA, DAVIS
HEALTH SYSTEM
GENERAL CLINICAL RESEARCH CENTER
MATHER, CALIFORNIA
STANDING PHYSICIAN ORDERS
GCRC Protocol # 51 --
Effect of Docosahexaenoic Acid (22:6n-3, DHA) Supplementation on Risk Factors for
Cardiovascular Disease in Hyperlipidemic Men
In case of emergency please contact
PI: John Smith, MD:
RA: Jane Doe:
Pager:
Pager:
916-257-xxxx
916-762-xxxx
Office: 366-xxxx
Office: 734-xxxx
______ Admit subject to GCRC outpatient clinic per protocol for Screening Visit
Condition: Stable
Allergies: __________________________________________
Vital Signs: BP, HR, Height and Weight
RA to provide labeled blood specimen tubes for GCRC RN to draw the following:
1.
2.
3.
4.
5.
One 5cc gel top for PI Plasma, clot for 30 minutes, spin cold at 3000rpm (1300 x g) for 10 minutes, place gel
top in GCRC lab refrigerator for study staff to pick up.
One 5cc green top chemistry, RA to send to VAMC Clin Lab
One 5cc purple top for CBC, RA to send to VAMC Clin Lab
One 5cc purple top for HBA1C, RA to send to VAMC Clin Lab (if subject is diabetic only)
One 5cc gel top for lipids, RA to send to VAMC Clin Lab
Discharge subject home
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EXAMPLE B
Patient Plate
UNIVERSITY OF CALIFORNIA, DAVIS
HEALTH SYSTEM
GENERAL CLINICAL RESEARCH CENTER
MATHER, CALIFORNIA
STANDING PHYSICIAN ORDERS
GCRC Protocol # 01 -- Lipoprotein Metabolism in HIV Positive Subjects
In case of Emergency please contact
PI: John Smith, MD:
Pager 916-762-xxxx
RA: Jane Doe
Office 916-734-xxxx Pager 916-762-xxxx
_____Admit volunteer to GCRC outpatient clinic per GCRC study #1 protocol
Condition: Stable
Allergies: __________________________________________
Vital signs: Routine, provide pharmacy with the subject’s weight
IV: Two saline lock IVs: 1 – 20g for medication administration and 1 – 18g or 20g for blood draws
Diet: Fasting upon admission, then pre-prepared meals at T -60, T70, T3hr:10, T5hr:10, T7hr, T9hr, and
T11hr.
Patient will be given a small snack prior to discharge.
Activity: ad lib
Medications (prepare all for administration at T=0 – after T=0 lab draw):
Bolus injection of deuterated leucine (conc. 5mg/ml), 5mg/kg body weight, IVP over 10 minutes
by Dr. Berglund.
Subjects may take the following medications as needed:
Tylenol 650mg PO q4-6hrs PRN for pain
Maalox 30ml PO PRN
Elamax Cream for IV insertion PRN
Subjects may take own medications from home:
Drug Name
Dose
Route
Frequency
MD Verification
Labs: Draw blood samples at 10 minutes prior to medication administration (-10) and at 0, 10, 20, 30, 40, 50, 60, 2hr, 3
hr, 4hr, 5hr, 6hr, 8hr, 10hr, 12hr, 24hr post medication administration as per protocol.
Labeled specimen collection and pour off tubes to be supplied by study staff. GCRC to collect and PI research staff to
process, package and ship to PI lab for analysis.
T-10:
1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T10:
1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T20:
1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T30:
1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots and
freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T40:
1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
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1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T50:
1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in
1ml aliquots and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
T60:
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T2hr: 1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T3hr: 1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T4hr: 1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T5hr: 1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T6hr: 1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T 8hr: 1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T10hr: 1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
T12hr: 1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum in 1ml aliquots
and freeze at -70C
Remove IV Saline Locks, remind subject to fast until 24hr blood draw, discharge subject home.
T24hr:
1-10cc Purple top: Draw on ice, spin cold for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquot and
freeze at -70C
1-7cc Gel top: Draw at room temp, spin cold for 15 minutes @ 3000 rpm, transfer serum
in 1ml aliquots and freeze at -70C
Offer snack to subject, discharge subject
MD signature: ________________________________________ Date: ___________________
18
Patient Plate
UNIVERSITY OF CALIFORNIA, DAVIS
HEALTH SYSTEM
GENERAL CLINICAL RESEARCH CENTER
MATHER, CALIFORNIA
Date______________________ SID# _______________
Processing Instructions
All Purple Tops: Draw on ice, spin at 4º C for 15 minutes @ 3000 rpm, transfer plasma in 1ml aliquots
and freeze at -70º C
All Gel Tops: Draw at room temp, clot for 30 minutes, spin at 4º C for 15 minutes @ 3000 rpm, transfer serum
in 1ml aliquots and freeze at -70º C
Time
Points
Time
-120
0700
-60
0800
-10
0850
0
0900
10
0910
20
0920
30
0930
40
0940
50
0950
60
1000
70
1010
2hr
1100
3hr
1200
Actual
Time
Procedure
RN Signature
ADMISSION, ORIENTATION, VITAL SIGNS,
INSERT IVX2.
Small Meal
Initial blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
Administration of deuterated leucine,
1ml/kg body weight, IVP over 10
minutes by Dr. Berglund.
10 min blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
20 minute blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
30 min blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
40 minute blood sample
1 purple top (10 ml plasma)
1gel top
50 minute blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
1 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
Small Meal
2 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
3 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
19
Patient Plate
UNIVERSITY OF CALIFORNIA, DAVIS
HEALTH SYSTEM
GENERAL CLINICAL RESEARCH CENTER
JMATHER, CALIFORNIA
3hr,
10
1210
4hr
1300
5hr
1400
5 hr,
10
1410
Small Meal
6hr
1500
6 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
7hr
1600
Small Meal
8hr
1700
8 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
9hr
1800
Small Meal
10hr
1900
10 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
11 hr
2000
Small Meal
12hr
2100
12hr,
5
2105
24hr
0900
24hr
0910
Small Meal
4 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
5 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
12 hour blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
Remove IVx2, Discharge patient with
instructions to fast until after 24hr blood
sample
24 hr blood sample
1 purple top (10 ml plasma)
1 gel top (7ml serum)
Snack, discharge patient.
20
EXAMPLE C
Patient Plate
UNIVERSITY OF CALIFORNIA, DAVIS
HEALTH SYSTEM
GENERAL CLINICAL RESEARCH CENTER
MATHER, CALIFORNIA
STANDING PHYSICIAN ORDERS
GCRC Protocol # 07 -- Bone Response to Soy Isoflavones in Women
In case of Emergency please contact
Dr. John Smith:
Pager : 916-762-xxxx
PI: Joe Jones:
Office: 530-752-xxxx
Cell 916-524-xxxx
RA: Jane Doe:
Office 530-752-xxxx
Cell 530-848-xxxx
______ SCREENING VISIT
Admit volunteer to GCRC outpatient clinic per protocol
Condition: Stable
Allergies: __________________________________________
RA to do Bone Density measure of lumbar spine and total femur
RN to draw one fasting 10cc red top for clinical chemistry, lipids and thyroid; send to UCDMC Clinical lab
Provide subject with a snack after procedures
______ BASELINE VISIT
RA to do Bone Density measures: Whole body, spine, femur and PQCT
Transvaginal Ultrasound performed in Department of Radiology
RA will process 24 hour urine collection as per protocol
RN to draw on ice, RA to process: 1 – 4ml plastic and 4 – 5ml glass lavender tops, 4 – 7ml glass green tops,
1 – 7ml plastic and 3 – 7ml glass red tops, and 1 – 8ml CPT
Provide subject with a snack after blood draw
HT, WT, BP, Heart Rate
TH
______ 6 MONTH VISIT
RA to do Bone Density measures: Whole body, spine, femur
RA to process 24 hour urine collection as per protocol
RN to draw on ice, RA to process: 1 – 4ml plastic and 4 – 5ml glass lavender tops, 4 – 7ml glass green tops,
1 – 7ml plastic and 3 – 7ml glass red tops, and 1 – 8ml CPT
Provide subject with a snack after blood draw
HT, WT, BP, Heart Rate
TH
______ 12 MONTH VISIT
RA does Bone Density measures: Whole body, spine, femur and PQCT
Transvaginal Ultrasound performed in Department of Radiology
RA to process 24 hour urine collection as per protocol
RN to draw on ice, RA to process: 1 – 4ml plastic and 4 – 5ml glass lavender tops, 4 – 7ml glass green tops,
1 – 7ml plastic and 3 – 7ml glass red tops, and 1 – 8ml CPT
Provide subject with a snack after blood draw
HT, WT, BP, Heart Rate
______ 24TH MONTH VISIT
RA does Bone Density measures: Whole body, spine, femur and PQCT
Transvaginal Ultrasound performed in Department of Radiology
RA to process 24 hour urine collection as per protocol
RN to draw on ice, RA to process: 1 – 4ml plastic and 4 – 5ml glass lavender tops, 4 – 7ml glass green tops,
1 – 7ml plastic and 3 – 7ml glass red tops, and 1 – 8ml CPT
Provide subject with a snack after blood draw
HT, WT, BP, Heart Rate
______ 36TH MONTH VISIT
RA does Bone Density measures: Whole body, spine, femur and PQCT
Transvaginal Ultrasound performed in Department of Radiology
RA to process 24 hour urine collection as per protocol
RN to draw on ice, RA to process: 1 – 4ml plastic and 4 – 5ml glass lavender tops, 4 – 7ml glass green tops,
1 – 7ml plastic and 3 – 7ml glass red tops, and 1 – 8ml CPT
Provide subject with a snack after blood draw
HT, WT, BP, Heart Rate
Discharge from protocol.
MD signature: ________________________________________ Date: ___________________
21
EXAMPLE D
Patient Plate
UNIVERSITY OF CALIFORNIA, DAVIS
HEALTH SYSTEM
GENERAL CLINICAL RESEARCH CENTER
MATHER, CALIFORNIA
STANDING PHYSICIAN ORDERS
GCRC Protocol # 41 -- Hypopituitarism after Moderate to Severe Head Injury – Chronic Phase II Stimulation Testing
In case of Emergency please contact PI: John Smith, M.D.
Pager 762-xxxx Office: 734-xxxx
Research Nurse: Jan Doe, RN Pager 762-xxxx Office: 734-xxxx
_____
Admit volunteer to GCRC outpatient clinic per GCRC study #41 protocol; SID # is _____________
Allergies: __________________________________________
Vital signs: Routine, measure height and weight and give to pharmacy
IV: Two saline lock IVs: 1 – 20g for medication administration and 1 – 18g or 20g for blood draws
Diet: NPO until study completion, then regular
Medications (prepare all for administration at T=0, after T=0 lab draw):
GHRH (1mcg/kg) (Sermorelin Acetate, GEREF® ) stimulation test:
1. Inject 1 mcg/kg IVP
2. Follow with a 5 mL normal saline flush.
Low dose (1 mcg) Cortrosyn stimulation test:
1. Obtain a 250 mL bag of Normal Saline
2. Withdraw 1 mL from the 250 mL Normal Saline bag and use this 1 mL to reconstitute the 250 mcg of
Cortrosyn (the standard amount in each vial of Cortrosyn)
3. Add the reconstituted solution back to the original bag of Normal Saline. The resultant concentration of the
Cortrosyn solution is 1 mcg/mL.
4. Administer 1 mL of the 1mcg/mL solution IV over 5-10 seconds.
5. Follow with a 5 mL normal saline flush.
GnRH (Gonadotropin releasing hormone):
1. Give GnRH 100 mcg IV push immediately after time 0 blood draw
2. Follow with a 5 mL normal saline flush.
Start Arginine infusion at time 0 (30 grams over 30 minute infusion time)
1. Follow with a 5 mL normal saline flush.
Labs: At admission, obtain a 12cc urine sample, freeze for chemistry; urine pregnancy test for all females, notify PI or
Research Nurse of a positive result only.
Draw blood samples 30 minutes prior to medication administration (-30) and at 0, 15, 20, 30, 60, 90, 120 minutes post
edication administration as per protocol.
Labeled specimen collection and pour off tubes to be supplied by study staff. GCRC staff to collect and process; PI research
staff to package and ship to UCLA for analysis.
T-30:
1 - 5cc Red or Tiger top (GH, Cort, LH, FSH); Draw at room temp, clot for 30 minutes, spin cold for 15
minutes @ 2500 RPM, separate serum into two transfer tubes, freeze at –20C
T0:
1 - 10cc Red or Tiger top (GH, Cort, LH, FSH, IGF1,1GFBP3, T4, FT4, TSH, estradiol, testosterone);
Draw at room temp, clot for 30 minutes, spin cold for 15 minutes @ 2500 RPM, separate serum into four
transfer tubes, freeze at –20C
1 – 2.5cc Lavender top (ACTH); Draw on ice, spin cold within 15 minutes for 15 minutes @2500 RPM,
transfer plasma into one tube and freeze at –70c
1 – 5cc tiger or red top (Prolactin, NA, BUN, Cr, Osmo); Draw at room temp, clot for 30 minutes, spin
cold for 15 minutes @ 2500 RPM, separate serum into two transfer tubes, freeze at –20C
1 – 10cc Lavender top (AVP); Draw on ice, spin cold within 15 minutes for 15 minutes @2500 RPM,
transfer plasma into one tube and freeze at –70c
T15:
1 – 2.5cc Tiger or Red top (GH); Draw at room temp, clot for 30 minutes, spin cold for 15 minutes @
2500 RPM, separate serum into one transfer tube, freeze at –20C
T20:
1 – 2.5cc Tiger or Red top (cortisol); Draw at room temp, clot for 30 minutes, spin cold for 15 minutes @
2500 RPM, separate serum into one transfer tube, freeze at –20C
T30:
1 – 2.5cc Tiger or Red top (GH, LH, FSH, cortisol); Draw at room temp, clot for 30 minutes, spin cold for
15 minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –20C
T60:
1 – 2.5cc Tiger or Red top (GH, LH, FSH); Draw at room temp, clot for 30 minutes, spin cold for 15
minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –20C
T90:
1 – 2.5cc Tiger or Red top (GH, LH, FSH); Draw at room temp, clot for 30 minutes, spin cold for 15
minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –20C
T120: 1 – 2.5cc Tiger or Red top (GH, LH, FSH); Draw at room temp, clot for 30 minutes, spin cold for 15
minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –20C
Remove IV Saline Locks, offer subject a snack, and discharge subject home.
MD signature: ________________________________________ Date: ___________________
22
PROTOCOL #41 FLOWSHEET
Time
Points
Time
Actual
Time
Procedure
RN
VS: BP __________ HR_______ RR _______ Temp _______HT __________ WT
__________
Admission
•
•
•
T –30
Notify Pharmacist of HT and WT
Insert Saline Locks
12cc urine sample, freeze for chemistry; urine pregnancy test for females, notify
PI or Research Nurse if positive only
1 - 5cc Red or Tiger top (GH, Cort, LH, FSH); Draw at room temp, clot for 30 minutes,
spin cold for 15 minutes @ 2500 RPM, separate serum into two transfer tubes, freeze
at –20C
1 - 10cc Red or Tiger top (GH, Cort, LH, FSH, IGF1,1GFBP3, T4, FT4, TSH, estradiol,
testosterone); Draw at room temp, clot for 30 minutes, spin cold for 15 minutes
@ 2500 RPM, separate serum into four transfer tubes, freeze at –20C
1 – 2.5cc Lavender top (ACTH); Draw on ice, spin cold within 15 minutes for 15
minutes @2500 RPM, transfer plasma into one tube and freeze at –70c
1 – 5cc tiger or red top (Prolactin, NA, BUN, Cr, Osmo); Draw at room temp, clot for 30
minutes, spin cold for 15 minutes @ 2500 RPM, separate serum into two
transfer tubes, freeze at –20C
1 – 10cc Lavender top (AVP); Draw on ice, spin cold within 15 minutes for 15 minutes
@2500 RPM, transfer plasma into one tube and freeze at –70c
Administer Meds:
GHRH (1mcg/kg) (Sermorelin Acetate, GEREF® ) stimulation test:
3. Inject 1 mcg/kg IVP
4. Follow with a 5 mL normal saline flush.
Low dose (1 mcg) Cortrosyn stimulation test:
6.
Administer 1 mL of the 1mcg/mL solution IV over 5-10 seconds.
7.
Follow with a 5 mL normal saline flush.
GnRH (Gonadotropin releasing hormone):
3. Give GnRH 100 mcg IVP
4. Follow with a 5 mL normal saline flush.
Start Arginine infusion (30 grams over 30 minute infusion time)
1. Follow with a 5 mL normal saline flush
T0
1 – 2.5cc Tiger or Red top (GH); Draw at room temp, clot for 30 minutes, spin cold for
15 minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –20C
T15
1 – 2.5cc Tiger or Red top (cortisol); Draw at room temp, clot for 30 minutes, spin cold
for 15 minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –20C
1 – 2.5cc Tiger or Red top (GH, LH, FSH, cortisol); Draw at room temp, clot for 30
minutes, spin cold for 15 minutes @ 2500 RPM, separate serum into one transfer tube,
freeze at –20C. End Infusion
1 – 2.5cc Tiger or Red top (GH, LH, FSH); Draw at room temp, clot for 30 minutes, spin
cold for 15 minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –
20C
1 – 2.5cc Tiger or Red top (GH, LH, FSH); Draw at room temp, clot for 30 minutes, spin
cold for 15 minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –
20C
1 – 2.5cc Tiger or Red top (GH, LH, FSH); Draw at room temp, clot for 30 minutes, spin
cold for 15 minutes @ 2500 RPM, separate serum into one transfer tube, freeze at –
20C
T20
T30
T60
T90
T120
Study Completed. D/C Saline Locks, Offer Snack, Discharge Subject Home.
RN SIGNATURE
INITIALS
RN SIGNATURE
INITIALS
23
CLINICAL RESEARCH PHARMACY
The investigational pharmacies at UCDHS and the VA Northern California Health Care System (VANCHCS)
Pharmacy Service collaborate to provide the pharmacy service for the GCRC. All investigational agents are
initially shipped to the Institution that has been granted the award. Currently, our investigational agents are
shipped first to UCDMC where our Investigational Pharmacy Service receives the drug. Bulk shipment to the
Sacramento VAMC Investigational Pharmacy can be made daily and individual patient doses are prepared
by the VA Investigational pharmacist and dispensed to patients in the GCRC.
Both UCDMC and the VANCHCS Investigational Drug Services ensure that adequate safeguards for the
patient, medical staff, VA, and UC Davis, are present and that accepted ethical, legal, and scientific
standards of care are followed.
Both the UC Davis and the VANCHCS Investigational Pharmacy Services provide excellent pharmaceutical
care while maintaining the documentation and service necessary for investigators to complete their research
and satisfy research sponsors and monitoring agencies. Some of the benefits of these services include
greater reliability and accountability of research data, increased patient monitoring for outcomes including
drug efficacy and reporting adverse events, and increased patient compliance with study criteria.
The UCDMC and VAMC will also work to provide the GCRC with non-investigational medications. The
UCDMC Pharmacy will provide the GCRC with a standardized stock of medications. These medications will
remain on the GCRC in the medication room. These medications include, but are not limited to, analgesics,
antihistamines, narcotics, antidiabetics, and antiemetics The VAMC Pharmacy will provide the GCRC with
medications in emergency situations.
Make certain that drug is available prior to booking the first subject.
Contact Vickie Bradley, Investigational Drug Pharmacist at UCDMC, regarding all drugs that will be issued by
UCDMC pharmacy.
Contact Brad Brazil or Sarah Schmidt for VA Pharmacy services.
Contact Information:
Victoria A. Bradley, Pharm.D.
Investigational Drug Service
UC Davis Medical Center
2315 Stockton Blvd, Room DT 0762
Sacramento, CA 95817
(916) 703-4093 Phone
Brad Brazill, Pharm. D.
Sacramento VAMC
Building 722
(916) 843-7190
Bradley.Brazill@med.va.gov
victoria.bradley@ucdmc.ucdavis.edu
24
RESEARCH RELATED EQUIPMENT APPROVALS
Equipment that is not standard on the GCRC must be evaluated and approved for usage by the VA
Biomedical Engineer who can be reached at 366-5481.
Basic competencies must be met by all staff who are expected to use the equipment. Inservices for
equipment training provided by the research team should be coordinated with the Nurse Manager.
These inservices can be held at the protocol start up meeting or at another convenient time, but must be
held prior to the first subject’s scheduled visit.
25
ADMISSION PROCEDURES
SCHEDULING
Contact Nicole Mullen (843-9426) or Joe Ann Sheppard (843-9429) if you have questions regarding
scheduling.
Bed Availability: All attempts will be made to accommodate the scheduling of research subjects.
Priorities are always given in the following order:
•
Research ‘A’ (strictly research)
•
Research ‘B’ (research combined with treatment/diagnostic)
•
Research ‘D’ (industry-sponsored studies)
A Scheduling Request form must be faxed to the GCRC 10 – 14 days prior to the requested date.
You will receive appointment confirmation within 24 hours if submitted Monday thru Thursday. If
submitted after 12 noon on Thursday, you will receive confirmation on the following Monday.
The following information is required to book the subject:
•
GCRC Protocol Number and Title
•
PI Name
•
RA Name
•
Date and Time of arrival and anticipated discharge
•
Subject’s Name, gender, DOB, and SSN
•
Subject’s home address and phone #
•
UCD MRN
•
Special Equipment or Dietary Needs
Consent forms are the responsibility of the investigator and the research team. No procedures or tests
can begin without signed informed consent. For subjects who are consented prior to admission, fax a
copy of the consent form along with the reservation form. Consent forms that are signed upon subject’s
admission will be copied x2, one for the subject and one to be kept in the medical record. The
investigator retains the original copy.
26
PHYSICIAN ORDERS
Signed orders must be at the GCRC prior to the subject’s visit. They can be faxed with the Scheduling
Request form, with the original to follow on the day of the study visit.
Orders can be expedited by including the following information:
• Allergies
• Comprehensive list of all medications to be taken at the bedside (The PI and/or MD must ID all
medications to be left at the bedside). Remind patients to bring in small quantities of meds,
especially narcotics.
• List of covering physicians if members of the research team are not available.
PATIENT CARE INFORMATION
•
Inpatient admissions require admitting H&P completed with 24 hours of admission. Daily progress
notes and discharge summaries are also required for each inpatient.
•
Housestaff coverage requirements are determined during the GCRC Advisory Committee (GAC)
Approval Process. Covering housestaff is assigned by admitting. The Principal Investigator is
responsible for meeting with housestaff to review the protocol, patient and orders.
•
If no housestaff coverage was agreed upon by the GAC, the Principal Investigator or a designee is
responsible for coverage.
•
The Principal Investigator’s team is responsible for night and weekend coverage of patients.
•
The GCRC nurses must have access to investigators through pagers and/or phone numbers at all
times. The Program Director is available for emergency calls only.
TERMS AND CONDITIONS AND NOTICE OF PRIVACY PRACTICES
During their first visit, all subjects seen on the GCRC must sign a UCDHS Terms and Conditions of
Service form and Acknowledgement of Receipt: Notice of Privacy Practices form. The GCRC retain
the original in the subject’s medical record and the subject should be given the carbon copy.
MEDICAL RECORD MANAGEMENT
•
A GCRC medical record is created for every subject seen on the GCRC. Medical records are
currently being stored in a locked file cabinet on the GCRC. They are organized in alphabetical
order.
•
Upon patient discharge, GCRC staff will copy research related orders and flowsheets for the Principal
Investigator.
•
Original flowsheets are kept in the GCRC medical record.
•
Charts are accessible during working hours. Charts may not be removed from the GCRC
27
1