CLINICAL RESEARCH SERVICES
BUDGET ESTIMATE REQUEST FORM
Revised February 7, 2016
Email completed form to crsbudgetrequest@ucsf.edu
Budget estimates are per participant unless requested otherwise
INVESTIGATIVE TEAM PERSONNEL
Protocol Title:
Principal Investigator (Financially Responsible PI):
Title (Professor, Associate Professor, etc.):
Department :
Financial Contact Name :
Other Study Personnel Name(s) :
Email:
Phone:
Financial Contact Email :
Other Study Personnel Email(s) :
FUNDING INFORMATION
Funded
Pending funding
Anticipated Start Date:
Anticipated End Date:
FUNDING SOURCE
Please check the appropriate box and specify the agency/sponsor name
Federal (NIH, NSF, DOD, etc.) :
Non-profit Organization :
Industry (Investigator-initiated) :
SFVAMC :
University (non-UCSF) :
Cooperative Group :
Industry (Sponsor-initiated) :
Investigator-initiated (non-sponsored) :
NCIRE :
External Entity :
STUDY TYPE (CHECK ALL THAT APPLY)
Clinical Trial
Translational Science
Behavioral Science
Basic Science
SITES REQUESTED
Please indicate your preferred site(s) for this work; use numbers to prioritize your preference (if applicable):
Adult Outpatient Units
Parnassus Outpatient (Monday-Friday, 08:00-18:00;
Visits >8hrs Tu & Th only; Closed campus holidays)
SFGH Outpatient
(Monday-Friday, 07:00-15:00)
San Francisco Veterans Affairs Medical Center
(Monday-Friday, 08:00-17:00)
Mt. Zion – Sample processing only
(Monday-Friday, 08:00-17:00)
Adult Inpatient Units
Moffitt Hospital
Inpatient
2/7/16 3:18 AM
SFGH Inpatient
Pediatric Outpatient Units
Benioff Children’s Hospital Mission Bay –
Pediatrics (Monday-Friday, 08:00-18:30)
Benioff Children’s Hospital Mission Bay - NCRC/
Critical Care Unit
Pediatric Inpatient Units
Benioff Children’s Hospital Mission Bay –
Inpatient Pediatrics
1
PROJECTED PARTICIPANTS & SPACE UTILIZATION
PARTICIPANT AGE RANGE (CHECK ALL THAT APPLY)
Prenatal
> 10 - 17 years
Birth - 1 month
> 18 - 64 years
> 1 month - 2 years
> 64 years
> 2 - 10 years
Specify Major Eligibility Criteria:
Study Arm
# Participants
# Inpatient Days
# Outpatient Visits
# Mobile Visits
(e.g. Screening, Arm A, etc.)
SPECIALITY ROOMS REQUIRED FOR STUDY
Smoking isolation (SFGH only)
# hrs:
Private consult / Interview
# hrs:
Negative pressure isolation
# hrs:
Monitored sleep room (SFGH and Moffitt Adult only)
# hrs:
Lead-lined room (UCSF Benioff Children’s Hospital) # hrs:
Applicant Comments:
EQUIPMENT REQUIRED FOR STUDY
Indicate CRS equipment needed for the study (e.g. infusion pumps, hand-warming box, glucose analyzers, cardiac
monitor, blood pressure machines, SP02 monitors):
List study-team provided equipment that will be used for this study:
REQUESTED CRS RESOURCES
NCRC COORDINATOR
COORDINATOR SERVICES
☐Screening
☐Procedure scheduling
2/7/16 3:18 AM
☐Family follow-up
2
BODY COMPOSITION, EXERCISE PHYSIOLOGY, AND ENERGY METABOLISM
In addition to testing services, the core offers consultation in protocol development and data interpretation, training, and
assistance with referrals for other types of testing available at UCSF (e.g. heavy water analysis).
Core Director and Contact – John Shepherd, PhD, 415-476-8814, john.shepherd@ucsf.edu
Select all that apply:
# Tests/
Participant
DEXA
Exercise, Functional Testing
Whole-body scan
Treadmill w/ ECG
Hip scan
Treadmill w/ ECG and VO2 (VO2 peak or
max)
Spine scan
Cycle ergometer test w/ ECG
Forearm scan
Cycle ergometer test w/ ECG and VO2
(VO2 peak or max)
Lateral vertebral assessment
Biodex: simple (1-2 positions, e.g., back
OR knee and hip)
Infant scan
Biodex: complex (>2 positions)
Other Body Composition Tests
# Tests/
Participant
6-minute walk test
Optical Imaging (Fit3D)
4M gait speed
Multifrequency bioelectrical
impedance spectroscopy (BIS)
Stair climb (routine)
Single frequency bioelectrical
impedance analysis (BIA)
Grip strength
Bod Pod© (air displacement
plethysmography)
Short Physical Performance Battery
(SPPB)
Skin folds (please specify)
Upper body ergometer
Circumferences (please specify)
Electrocardiogram
Anthropometry: waist/hip ratio
Other (specify)
Other (specify)
Other services: Please provide details below
Ultrasound (Moffitt only); Note: PI must
supply probe and staff to perform ultrasound
measurements
Abdominal, hepatic
Training
Brachial
Data analysis
Carotid
Consulting
Other (specify)
Applicant Comments:
2/7/16 3:18 AM
3
NURSING
If your study is complex in nature, contact the nurse manager at the site where you plan to conduct the majority of your
research prior to submitting this application.
Parnassus
Mission Bay Benioff Children’s Hospital
SFGH
VAMC
Hector Vizoso, RN, MSN, 415-218-4927, hector.vizoso@ucsf.edu
Michele Downing, RN, 415-502-2683, Michele.Downing@ucsf.edu
Bernadette Tobin, RN, 415-206-8239, Bernadette.Tobin@ucsf.edu
Wesley Stratton, RN, Wesley.Stratton@ucsf.edu
On your Schedule of Events, please highlight/indicate which services you are requesting from the CRS
Requesting CRS mobile nurse services. (If requesting mobile services, please contact the appropriate Nurse Manager to
ensure the CRS can accommodate your needs)
COMMON PROCEDURES
*Note: Parnassus OP visits lasting >8hrs only on Tues/Thurs
IP / OP
IP / OP
/
Vitals Signs: Single position
/
Vital Signs : Multiple positions
/
/
Height / Weight / BSA
Direct Venipuncture <= 4 tubes (single lab)
/
/
/
Specimen Collection (Standard handling)
/
/
Medication Administration: PO, IM, SQ
/
ECG (12 lead): Single timepoint, No interpretation
/
PK Serial Blood Testing*: # of timepoints =
METABOLIC TESTING
IP / OP
/
Oral Glucose Tolerance (2 hr Test)
/
IVGTT
/
Glomerular Filtration Rate (3hr Test)
/
Mixed Meal Tolerance (2 hr Test)
/
Hyperinsulinemic-Euglycemic Clamp
PROCEDURAL ASSISTANCE
IP / OP
/
Moderate Sedation Administration by RN*
/
Bone Biospy Assistance
/
Bronchoscopy Assistance*
/
Fat Biopsy Assistance
PATIENT MONITORING
IP / OP
/
Patient Monitoring Post Treatment: 1 medication
/
Cardiac Monitoring & Lead Placement
OTHER
IP / OP
/
Blood / Blood Product Infusion
/
Pre Medications for Infusions
/
Central Line Access
/
IV Access (Pediatric or Dialysis)
/
Mediport Access
/
/
Patient Teaching
PPD Placement and Reading
/
/
/
IP / OP
/
/
/
/
/
IP / OP
/
/
/
/
POCT: HCG, Blood Glucose, HbA1C (PCRC), Hgb (SFGH)
Direct Venipuncture > 4 tubes and/or multiple lab sendouts
Specimen Collection (Special handling procedures and/or
patient isolation)
Medication Administration: IV and/or High-risk meds
ECG (12 Lead): Multiple timepoints, No interpretation
Facility Use:
Duration (min) =
Oral Glucose Tolerance (3 hr Test)
Frequent Sample IV Glucose Tolerance Test
Glomerular Filtration Rate (4hr Test)
Mixed Meal Tolerance (4 hr Test)
Steady State Plasma Glucose
*NOT available in Parnassus OP clinic
Liver Biopsy Assistance*
Lumbar Puncture Assistance
Muscle Biopsy Assistance
Node Biopsy Assistance
IP / OP
/
/
Patient Monitoring Post Treatment: >1 medication
Holter Monitor
IP / OP
/
/
/
/
/
Blood Bag Draw up to 500cc
Hydration Pre and Post infusion
PICC Line Access
IV Access
Strict I / O
/
/
Questionnaires (administered by CRS staff)
Skin Testing
Applicant Comments:
2/7/16 3:18 AM
4
SAMPLE PROCESSING SERVICES
If your study is complex in nature, contact the sample processing manager at the site where you plan to conduct
the majority of your research prior to submitting this application.
Lab Operating Hours: Monday-Friday, 08:00-17:00; closed on campus holidays
Sample Processing Director and Contact:
Nick Larocque, MS, 415-218-3698, nicholas.larocque@ucsf.edu
Veterans Affairs Medical Center Contact:
Hector Vizoso, RN, MSN, 415-218-4927, hector.vizoso@ucsf.edu
Select all that apply:
Sample Processing
# tubes per
participant
Sample Storage
Temperature
Serum, Plasma, or Whole Blood processing and aliquoting (1-10
aliquots)
+4°C Storage
Yes
No
Whole Blood without processing (DNA Bank, etc.)
-20°C Storage
Yes
No
Urine processing and aliquoting (1-10 aliquots)
-80°C Storage
Yes
No
Saliva processing and aliquoting (1-10 aliquots)
Liquid Nitrogen
storage
Yes
No
Sample Storage
CSF processing and aliquoting (1-10 aliquots)
Non-Routine processing - fluid with 11 or more aliquots, special
additives, or extra centrifugation step
1 Month Storage
PBMC isolation (up to 40mL)
2 Month Storage
Amiotic Fluid
3 Month Storage
Stool
4 Month Storage
Buccal
7 Month Storage
Biopsy
8 Month Storage
Estimated # of
vials (aliquots)
9 Month Storage
Other processing, please provide details:
10 Month Storage
Packaging and Shipping (all shipping costs paid by the
investigator)
# of Shipments
11 Month Storage
12 Month Storage
(Max)
Shipment, ambient or cold packs or dry ice
2/7/16 3:18 AM
5
SPECIAL BUDGETARY REQUESTS
Enter special requests here:
DOCUMENTS CHECKLIST
Please provide the following documents when applicable:




Protocol / Proposal
Schedule of Events
Coverage Analysis Determinations* (for nursing service requests at UCSF Medical Centers)
Lab Manual (for sample processing requests)
*Note that a budget estimate cannot be finalized without a record of the coverage analysis determinations
Email completed form to crsbudgetrequest@ucsf.edu
2/7/16 3:18 AM
6
APPENDIX 1: Descriptions of Nursing Procedures (alphabetical by title)
Nursing Procedure
Blood / Blood Product Infusion
Blood Bag Draw up to 500cc
Bone Biospy Assistance
Bronchoscopy Assistance
Cardiac Monitoring & Lead
Placement
Central Line Access
Direct Venipuncture < 4 tubes
(single lab)
Direct Venipuncture > 4 tubes
and/or multiple lab send-outs
ECG (12 lead): Single timepoint, No
interpretation
2/7/16 3:18 AM
Description
• Preparation (set up supplies, verify MD orders, verify patient and blood type, 2
RN check)
• Administer pre-medication
• Check vital signs pre-blood administration
• Remain with patient first 15 minutes of administration
• Check vital signs 15 minutes into administration and end of infusion
• Complete all required documentation
• Preparation (set up supplies, verify MD orders and consent)
• Obtain POCT hemoglobin prior to blood collection
• Check vital signs pre and post collection
• Monitor for AE’s
• Record blood volume and flow rate
• Provide post donation instructions to the patient
• Order and set up equipment
• Assist physicians with procedures
• Complete unit based procedure forms and transport specimens
• Includes patient preparation, teaching, and monitoring post procedure
• Set up room with equipment
• Prepare and teach patient
• Administer medications
• Complete unit based procedure forms
• Provide continuous nursing monitoring presence during actual bronchoscopy and
post-procedural recovery
• Recording of procedural data and discharge teaching
• Prep skin, apply cardiac leads, instruct patient regarding procedure
• Cardiac monitoring of patient during exercise testing and training procedures
• Setup of emergency equipment and medications for intervention if required
• Access a central line including ports, peripherally inserted central catheters, and
central line catheters
• Assemble all supplies for dressing care and access
• Prepare catheter flush, prepare patient, access site, connect tubing
• Infusion and/or draw all baseline lab specimens
• Flush line at end of procedure and complete catheter/site care
• Assemble supplies, print labels, prepare requisitions, instruct patient
• Draw through single access up to 4 tubes of blood and send out to a single lab for
assay or processing
• Assemble supplies, print labels, prepare requisitions, instruct patient
• Draw through single access more than 4 tubes of blood AND/OR send out to two
or more labs for assay or processing
• Obtain supplies, complete requisition, explain procedure to patient
• Apply leads, perform 12 lead EKG
• Make appropriate copies and complete documentation
7
ECG (12 Lead): Multiple timepoints,
No interpretation
• Obtain supplies, complete requisition, explain procedure to patient
• Apply leads, perform 12 lead EKG at designated timepoints
• Make appropriate copies and complete documentation
Facility Use (15min increments)
• Closed room to ensure privacy for consenting /screening
• No RN or phlebotomy services provided
Fat Biopsy Assistance
• Order and set up equipment
• Assist physicians with procedures
• Complete unit based procedure forms and transport specimens
• Includes patient preparation, teaching, and monitoring post procedure
• Preparation (set up supplies, verify MD orders and consent)
• Obtain vital signs and weight
• Insert IV
• Draw baseline bloods
• Monitor multiple infusions
• Blood draw timepoints (2,3,4,5,6,8,10,12,14,19,22,25,30,40,50,70,100,140,180
min)
• Monitor for AE’s
• Obtain supplies, including Omnipaque 350 & emergency meds (epinephrine,
Benadryl, and atropine)
• Set up tubes with labeled time point blood draws
• Verify no consumption of drugs that effect kidney function
• Inform participant of expected procedures during test period
• Insert peripheral IV and administer omnipaque
• Draw blood specimens to and send to lab
• Obtain supplies, including Omnipaque 350 & emergency meds (epinephrine,
Benadryl, and atropine)
• Set up tubes with labeled time point blood draws
• Verify no consumption of drugs that effect kidney function
• Inform participant of expected procedures during test period
• Insert peripheral IV and administer omnipaque
• Draw blood specimens to and send to lab
• Order equipment from EKG Department
• Schedule application times for entire protocol period
• Change electrodes and complete skin care on patient at 48• hour intervals
• Ensure patient completion of daily diary and complete nursing documentation
Frequent Sample IV Glucose
Tolerance Test
Glomerular Filtration Rate (3hr Test)
Glomerular Filtration Rate (4hr Test)
Holter Monitor
Height / Weight / BSA
• Obtain measured height and weight
• Could include BSA calculations for drug administration
Hydration Pre and Post
• Preparation (set up supplies, verify MD orders and consent)
• Insert IV
• NS Infusion
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8
Hyperinsulinemic-Euglycemic Clamp
IV Access (Pediatric or Dialysis)
IV Access
IVGTT
Liver Biopsy Assistance
Lumbar Puncture Assistance
Medication Administration: IV
and/or High-risk meds
2/7/16 3:18 AM
• Preparation (set up supplies, verify MD orders and consent)
• Obtain vital signs and weight
• Monitor Multiple Infusions
• Insert retrograde IV
• Provide hand warming box
• Insert second IV
• Draw baseline bloods and then bloods every 5 min
• Glucose analyzer
• Requires 1:1 nursing
• Assemble supplies
• Instruct pediatric/dialysis patient
• Start and secure IV line
• Assemble supplies
• Instruct patient
• Start and secure IV line
• Obtain supplies, fax MD orders to obtain medications
• Set up equipment for two peripheral IV lines
• Label all tubes, complete all lab requisitions and document all required
information on flow sheets and in UCare (if inpatient)
• Establish base level of glucose (determined by finger stick or venous sample to
meet required blood level start of 80-120mg/dl)
• May include setting up an insulin drip to meet this baseline glucose level range
• Start test by drawing -10 minute sample of glucose, insulin and C-peptide blood
levels
• Administer IV glucose and insulin at specified time points
• Draw blood at specified time points
• Discontinue IV lines at end of test
• Continue to monitor blood sugar until returns less 250mg/dl
• Provide patient with meal
• Provide adjusted normal insulin dose per MD orders
• Order and set up equipment
• Assist physicians with procedures
• Complete unit based procedure forms and transport specimens
• Includes patient preparation, teaching, safety lab draw for hematocrit and
monitoring post procedure
• Order and set up equipment
• Assist physicians with procedures
• Complete unit based procedure forms and transport specimens
• Includes patient preparation, teaching, and monitoring post procedure
• Order drugs
• Perform 2 RN independent double check of dosages for all injectable and oral
administration of Phase I investigational and/or high-risk medications
• Administer medications per MD orders
• May include up to 8 separate medications (including pre-meds and patients own
medications, provided in original containers and verified by pharmacist)
• Complete all documentation on UCare and flow sheets of medications
administered by the nurse during outpatient visit or inpatient stay
• Includes baseline assessments and reassessments for pain management
medications
9
Medication Administration: PO, IM,
SQ
Mediport Access
Mixed Meal Tolerance (2 hr Test)
Mixed Meal Tolerance (4 hr Test)
2/7/16 3:18 AM
• Review, prepare and administer oral medications
• May include up to four medications for one patient in a single protocol up
through a 24-hour period
• Includes only routine medications provided by UC pharmacy without high risk
checks
• Preparation (set up supplies, verify MD orders and consent)
• Huber needle
• Sterile field and dressing
• Heparin flush requires 2 RN sign off
• Obtain supplies, including Boost
• Set up labeled tubes for blood draw procedures at specified timepoints
• Complete baseline patient assessment and teaching to include confirmation
patient has followed pre-admission instructions on insulin and NPO except for
water
• Place peripheral IV line and obtain baseline glucose level to meet range of 80120mg/dl for start of procedure
• Run IV one half normal saline during procedure, calculate dose of Boost for oral
administration
• Draw blood samples at specified timepoints
• Administer Boost after -5 minute blood draw to be consumed within 5 minute
time frame
• Following MMTT, check fingerstick glucose, if <250mg/dl patient may eat with
adjusted insulin dose per MD order (if not, contact MD for Insulin after Metabolic
testing orders)
• Discharge once blood sugar returns to <200mg/dl
• Obtain supplies, including Boost
• Set up labeled tubes for blood draw procedures at specified timepoints
• Complete baseline patient assessment and teaching to include confirmation
patient has followed pre-admission instructions on insulin and NPO except for
water
• Place peripheral IV line and obtain baseline glucose level to meet range of 80120mg/dl for start of procedure
• Run IV one half normal saline during procedure, calculate dose of Boost for oral
administration
• Draw blood samples at specified timepoints
• Administer Boost after -5 minute blood draw to be consumed within 5 minute
time frame
• Following MMTT, check fingerstick glucose, if <250mg/dl patient may eat with
adjusted insulin dose per MD order (if not, contact MD for Insulin after Metabolic
testing orders)
• Discharge once blood sugar returns to <200mg/dl
10
Moderate Sedation Administration
by RN
Patient Monitoring Post Treatment:
1 medication
• Provide 1:1 nursing for monitoring and documentation of respiratory rate,
oxygenation status and hemodynamic status before, during and post drug
administration
• Continuous pulse oximetry, cardiac monitoring, blood pressure, pulse, respiratory
rate
• Continuous assessment of level of sedation and/or responsiveness to verbal and
tactile stimuli by titrating drug to the patient’s response using small incremental
doses of drugs
• Estimated time of drug administration is 15-30 minutes
• Total procedure time 60 to 120 minutes
• Patient must return to baseline aldrete score and all documentation of
monitoring parameters, documentation of meds administered and patient
assessment scores must be completed
• Order and set up equipment
• Assist physicians with procedures
• Complete unit based procedure forms and transport specimens
• Includes patient preparation, teaching, and monitoring post procedure
• Order and set up equipment
• Assist physicians with procedures
• Complete unit based procedure forms and transport specimens
• Includes patient preparation, teaching, and monitoring post procedure
• Obtain supplies including oral glucose solution
• Teach procedure components to participant and confirm NPO since midnight
except for water and medications
• Place one peripheral line for sequential IV draws or to draw each specimen
peripherally at specified time points
• Oral administration of glucose solution
• Discontinue IV if applicable and provide meal upon completion of OGTT
• Obtain supplies including oral glucose solution
• Teach procedure components to participant and confirm NPO since midnight
except for water and medications
• Place one peripheral line for sequential IV draws or to draw each specimen
peripherally at specified time points
• Oral administration of glucose solution
• Discontinue IV if applicable and provide meal upon completion of OGTT
• Assess patient & monitor for side effects of single medication
• Complete necessary documentation on forms (including Toxicity Assessment)
Patient Monitoring Post Treatment:
>1 medication
• Assess patient & monitor for side effects of multiple medications
• Complete necessary documentation on forms (including Toxicity Assessment)
Patient Teaching
PICC Line Access
Instruct and reinforce instructions for a patient in a single protocol
• Preparation (set up supplies, verify MD orders and consent)
• Sterile field and dressing
• Saline flush
PK Serial Blood Testing (per
timepoint)
•
•
•
•
Muscle Biopsy Assistance
Node Biopsy Assistance
Oral Glucose Tolerance (2 hr Test)
Oral Glucose Tolerance (3 hr Test)
2/7/16 3:18 AM
Teach patient regarding procedures required
Place one peripheral line for PK sampling (if needed)
Administer medication and draw up to 8 specimens
Includes all baseline labs if less than 4 tubes and sent to a single lab
11
POCT (HCG, Blood Glucose, HbA1C,
Hgb)
PPD Placement and Reading
Pre Medications for Infusions
Questionnaires (administered by CRS
staff)
Skin Testing
Specimen Collection (Special
handling procedures and/or patient
isolation)
Specimen Collection (Standard
handling)
Steady State Plasma Glucose
Strict I / O
Vital Signs : Multiple positions
Vitals Signs: Single position
2/7/16 3:18 AM
• Explain procedure to research participant
• Assure quality control testing is completed on testing materials prior to using
• Perform point of care testing for urine pregnancy, glucose levels, drugs of abuse,
HbA1C (at PCRC only), or Hgb (at SFGH only)
• Document results and notify responsible MD if any out of range or positive
results obtained
• Scan MD order to pharmacy and obtain supplies
• Explain procedure to research participant
• Perform injection and document administration
• Make appointment for patient to return for reading within 48 to 72 hours
• Result of PPD read and documented in medical record
• Preparation (set up supplies, verify MD orders and consent)
• Insert IV
• Administer IV Infusion or IV push medication
Administer one structured interview or written questionnaire (up to 15 minutes in
duration) at one designated time point
• Preparation (set up supplies, verify MD orders and consent)
• Apply allergens to skin
• Measure and record reactions
• Monitor for AE’s
• Obtain a specimen (urine, stool, blood, sputum, breath) requiring special
handling or processing, patient isolation, complex documentation and/or
distribution of specimens
• Does not include blood samples drawn by direct venipuncture or specimens
collected during pharmacokinetic study initiation
• Obtain a specimen (urine, stool, blood, sputum, breath)
• Does not include blood samples drawn by direct venipuncture or specimens
collected during pharmacokinetic study initiation
• Preparation (set up supplies, verify MD orders and consent)
• Blood glucose analyzer
• Monitor Multiple IV Infusions
• Obtain vital signs weight
• Insert two IV’s
• Draw blood every 30 min
• Monitor for AE’s
• All oral intake must be measured and/or counted and recorded
• All output must be measured and/or counted and recorded
VS taken in multiple positions at designated times
VS in one position only, taken at a designated time
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