I. Investigational Pharmacy

Office of Clinical University Hospital Research Scope of Research Services B-1177, CC 973-972-1026 This form should be used to request any hospital services related to the study that will not be provided by investigators. If any questions, please contact Tracie Saunders at 973-972-1026.

Protocol Number and Title: Investigator:

I. Investigational Pharmacy: All fees for service are outlined on the attached budgeted schedule of events (bSOE). The Initial N/A Protocol Setup and Inventory Maintenance Fee will not be charged to the study until drug is received by the IDS from the sponsor. All dispensing fees will be billed quarterly. Initial Protocol Setup Fee includes: Inventory Maintenance Fee includes:  Protocol review & assessment of pharmacy  Ordering study medication involvement  Receiving study medication  Preparation of IDS protocol budget  Storage  Preparation of drug accountability forms  Inventory record maintenance  Development of dispensing guidelines  Meetings with research monitors  Attend start-up meeting with investigator and study  Quality assurance checks sponsor  Collection, reconciliation and storage of returns  In-service of pharmacy staff, if necessary  Destruction of used or expired medication  Study close-out Inventory Maintenance: Low Intensity Moderate Intensity High Intensity Annual Renewal Fee x _____ years Parenteral Dispensing: Extemporaneous Dispensing:  IV syringes # of doses:  Compounding Fee - $--/hr + cost of materials if not provided # of hours  IV bags < 250 mL # of doses:  Dispensing Fee: # of RX:  IV bags >> 250 mL # of doses:  Chemotherapy – IV bags/infusers/syringes # of doses: Oral Dispensing: Other:  Outpatient dispensing: # of Rx:4 x  Special handling or preparation - $--/hr. # of hours:  Inpatient unit dispensing: # of Rx:

Materials and medication not provided by the investigator or sponsor may be obtained by special order at an additional cost. Please list additional services or supplies below: II. Pathology and Laboratory Medicine:

Pathology Services: Description of services needed on the samples outlined below/Special N/A Instructions:

Service Quantity Service Quantity General Request Immunohistochemistry Pull existing block(s) IP Antibody / Antibody Slide Pull existing slide(s) IP Antibody (provided by study) Super frost plus slide(s) Immuno. FL-Direct Adhesive slide(s) Immuno. FL-Indirect Histology In situ - Hybridization Process & embed (create block) New Antibody Work UP Unstained slides FISH-other IHC w/o interp Indicate unstained slide details below: FISH – Interpretation Standard (4 microns, Micron Thickness: Other: charged glass & baked) Charged Uncharged Baked Not Baked H&E Stained Electron Microscropy Trim & Cassette Scope Time – Use of EM Decalcification Process & Embed - Special Cut Section & Collect in vial Process & Embed - Regular Special Stains (List stain request below): Thick section Thin Section Prints/Digital Images Miscellaneous Work

Grossing (Simple/Complex)

Laboratory Services: N/A Procedure Description CPT Code # of Procedures

Please list additional services or supplies below: III. Patient Care Space:

Please check all locations involved in this protocol. N/A

Outpatient Locations Inpatient Care Areas

Ambulatory Care Services Critical Care Services Infectious Disease Clinic – D-level E-Blue Neurology/Neurosurgery – G-level E-Green-SICU Surgical Specialties – E-level E-Yellow-NICU  ENT G-Blue  General Surgery G-Green-NICU  Podiatry I-Blue  Urology E-Yellow CTICU/NICU OB/Gyn – C-level I-Yellow 2-CCU UMDCare & Medical Subspecialties – F-level I-Yellow 1-MICU  Adolescent I-Cardiac Cath  Cardiology  Hepatology  High Risk Emergency Services Emergency Room Cancer Center Hematology Clinic Family Health Services  Adult Hematology G-Green-PICU  Pediatric Hematology F-Blue  Primary Care F-Green Infusion Services F-Orange-FNN  Adult F-Orange FIN  Pediatric F-Orange-FICN Oncology Clinic F-Orange-L&D  Adult Oncology  Survivorship Medical/Surgical/Orthopedics & Liver Transplant Surgical Oncology Clinic H-Yellow-Medical/Oncology H-Green – Medical/Orthopedic Doctor’s Office Complex F-Yellow – Surgical/Liver Transplant Opthamology PM& R Perioperative Services Outpatient Therapy  E-416 Recovery Room/PACU  Physiatry DOC 0400 - Same Day Surgery SDS – E-Yellow University Hospita l E-178 - Medical Special Procedures Dental clinic - C401 Operating Room Orthopedic Clinic – C134 Radiation Oncology – A1120 Psychiatry Services G-Yellow - Psychiatry Lattimore Clinic Renal Dialysis Services D-Green – Acute Renal

Location Resources: N/A Use of supplies from unit stick (specify type and quantity:

Longer critical care stay (specify hours or days):

Longer inpatient stay (specify hours or days):

Additional outpatient visits (specify number): IV. Perioperative Services:

N/A Device/Procedure Information

What is/are the surgical procedure name(s) in which this product will be used?

Is the device FDA approved for the proposed use? Yes No Is this procedure new to University Hospital? Yes, never been performed here; No Who is paying for the procedure/device? Sponsor Patient Insurance Will University Hospital be responsible for purchasing the device? Yes No If yes, what is the purchase order information (PO#, catalog number, etc): ______and what is the authorized number of devices/products to be acquired? ______Does the device require storage? Yes No What is the method of delivery to the OR? Yes No Are there additional staff or facility needs required for this study? Yes No If yes, explain:

Will there be sponsor representatives or other non-University Hospital staff members needing to be present during the case? Yes No If yes, list: Name: Name: Will there be specimen collection during the case? Yes No If yes, list: Blood Urine Tissue Other:

V. Personnel:

Check all patient care services and hospital personnel involved in this study: N/A

Registered Nurse (RN) Nurse Educator

Licensed Practical Nurse (LPN) Manager/Director/Supervisor

Patient Care Technician/Ambulatory Care Technician Advanced Practice Nurse

Unit Clerk/Registration Staff Other

Patient Navigator

Assessments: Interventions (cont’d): Physical IV access Psychosocial Starting Behavioral Maintaining Spiritual Discontinuing Other: Additional IV access Keeping IV access in longer Planning: Other: Change from current standard of care Interdisciplinary rounds Tube(s): ______Patient/family conferences Placement Other: Maintenance Removal Interventions: Additional tube Monitoring Keeping tube in longer Vital signs New to system Post procedure Other: Device Cardiac Dressing(s): ______ECG Placement Telemetry Maintenance Fetal heart Removal Intraaortic balloon pump Additional dressing Other: Keeping dressing on longer Respiratory New to system Pulse Oximetry Other: Capnography Ventilator Device(s)/Equipment Other: Placement Other: Maintenance Removal Medications New to system Administration Titrating Extra Time for Patient Care Investigational Agent Administration Specific timing of assessments New delivery system Specific timing of monitoring Other: Extra documentation/charting Accompanying a patient of the unit Specimen Collection Follow-up communication (specify type and Blood frequency): Urine Other: Other: Other: Assistance with procedures (specify type and Teaching frequency: Patient Family member(s) Group(s) Others: N/A Check all specific research activities required to this protocol.

Sharing general information about the study Obtaining subject consent for study participation Identifying potential study subjects Collecting study data Patient Care Standards of Practice

Are any staffing services considered that are not considered standard of care? No Yes

Will interventions in this study represent a change from current standard of practice? No Yes Communication and Training

Provide the plan for communicating information about the study with the involved patient care unit:

Does this study require additional training for hospital staff? No Yes

If yes, describe the training to be offered: Who will provide training, the training strategy (e.g., in service, written materials, etc.), the proposed location, and the length of time required for training.

VI. Radiology Services:

Radiology Services: The following procedures have been requested. N/A Procedure Description CPT Code # of Procedures

Please list additional services or supplies below:

VII. Other Ancillary Services:

The following procedures have been requested. N/A Procedure Description CPT Code # of Procedures Please list additional services or supplies below: