Office of Clinical Research B-1177, CC 973-972-7909 Scope of Research Services 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 Arleen Wallen at 973-972-7909. Protocol Number and Title: Investigator: I. Investigational Pharmacy: All fees for service are outlined on the attached budgeted schedule of events (bsoe). The Initial 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: IV syringes # of doses: IV bags < 250 ml # of doses: IV bags >> 250 ml # of doses: Chemotherapy IV bags/infusers/syringes # of doses: Oral Dispensing: Outpatient dispensing: # of Rx: 4 x Inpatient unit dispensing: # of Rx: Extemporaneous Dispensing: Compounding Fee - $--/hr + cost of materials if not provided # of hours Dispensing Fee: # of RX: Special handling or preparation - $--/hr. # of hours: 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 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) Unstained slides Indicate unstained slide details below: Standard (4 microns, Micron Thickness: charged glass & baked) Charged Uncharged Baked Not Baked H&E Stained Trim & Cassette Decalcification Cut Section & Collect in vial Special Stains (List stain request below): New Antibody Work UP FISH-other IHC w/o interp FISH Interpretation Electron Microscropy Scope Time Use of EM Process & Embed - Special Process & Embed - Regular Thick section Thin Section Prints/Digital Images Miscellaneous Work Grossing (Simple/Complex) Laboratory Services: The following procedures have been requested. Procedure Description CPT Code # of Procedures Please list additional services or supplies below: Version 14 [4/30/2016] Page 2 of 6
III. Patient Care Space: Please check all locations involved in this protocol. Outpatient Locations Ambulatory Care Services Infectious Disease Clinic D-level Neurology/Neurosurgery G-level Surgical Specialties E-level ENT General Surgery Podiatry Urology OB/Gyn C-level UMDCare & Medical Subspecialties F-level Adolescent Cardiology Hepatology High Risk Cancer Center Hematology Clinic Adult Hematology Pediatric Hematology Primary Care Infusion Services Adult Pediatric Oncology Clinic Adult Oncology Survivorship Surgical Oncology Clinic Doctor s Office Complex Ophthalmology PM& R Outpatient Therapy Psychiatry University Hospital Dental Clinic - C401 Orthopedic Clinic C134 Radiation Oncology A1120 Lattimore Clinic Critical Care Services E-Blue E-Green-SICU E-Yellow-NICU G-Blue G-Green-NICU I-Blue E-Yellow CTICU/NICU I-Yellow 2-CCU I-Yellow 1-MICU I-Cardiac Cath Emergency Services Emergency Room Family Health Services G-Green-PICU F-Blue F-Green F-Orange-FNN F-Orange FIN F-Orange-FICN F-Orange-L&D Inpatient Care Areas Medical/Surgical/Orthopedics & Liver Transplant H-Yellow-Medical/Oncology H-Green Medical/Orthopedic F-Yellow Surgical/Liver Transplant Perioperative Services E-416 Recovery Room/PACU DOC 0400 - Same Day Surgery SDS E-Yellow E-178 - Medical Special Procedures Operating Room Psychiatry Services G-Yellow - Psychiatry Renal Dialysis Services D-Green Acute Renal Location Resources: 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): Version 14 [4/30/2016] Page 3 of 6
IV. Perioperative Services: 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? Explain: 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 V. Personnel: Check all patient care services and hospital personnel involved in this study: Registered Nurse (RN) Licensed Practical Nurse (LPN) Patient Care Technician/Ambulatory Care Technician Unit Clerk/Registration Staff Patient Navigator Assessments: Physical Psychosocial Behavioral Spiritual Version 14 [4/30/2016] Page 4 of 6 Nurse Educator Manager/Director/Supervisor Advanced Practice Nurse Other Interventions (cont d): IV access Starting Maintaining Discontinuing Additional IV access Keeping IV access in longer
Planning: Change from current standard of care Interdisciplinary rounds Patient/family conferences Interventions: Monitoring Vital signs Post procedure Device Cardiac ECG Telemetry Fetal heart Intraaortic balloon pump Respiratory Pulse Oximetry Capnography Ventilator Medications Administration Titrating Investigational Agent Administration New delivery system Specimen Collection Blood Urine Assistance with procedures (specify type and frequency: Tube(s): Placement Maintenance Removal Additional tube Keeping tube in longer New to system Dressing(s): Placement Maintenance Removal Additional dressing Keeping dressing on longer New to system Device(s)/Equipment Placement Maintenance Removal New to system Extra Time for Patient Care Specific timing of assessments Specific timing of monitoring Extra documentation/charting Accompanying a patient of the unit Follow-up communication (specify type and frequency): Teaching Patient Family member(s) Group(s) Others: Check all specific research activities required to this protocol. Sharing general information about the study Identifying potential study subjects Obtaining subject consent for study participation 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 Version 14 [4/30/2016] Page 5 of 6
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. Procedure Description CPT Code # of Procedures Please list additional services or supplies below: VII. Other Ancillary Services: The following procedures have been requested. Procedure Description CPT Code # of Procedures Please list additional services or supplies below: Version 14 [4/30/2016] Page 6 of 6