Application_for_Approval_to_Conduct_Research_Activities_at_Stony_Brook_University_Hospital(4.26.19)

Application for Approval to Conduct Research Activities At Stony Brook University Hospital Inpatient or Outpatient Facilities* v 04.25.19 *This application does not need to be completed for research activities exclusively conducted at non-article 28, UFPC outpatient facilities Principal Investigator:       Phone:       Study Coordinator:       Phone:       Project Title:       Registration of Activity Any research activity conducted at SBUH inpatient or outpatient facilities must be registered with either the Office of Clinical Trials (OCT), the Clinical Research Center (CRC), or the Cancer Clinical Trials Office (CCTO) for the purposes of ensuring regulatory compliance Choose the category in which your activity falls, and contact the appropriate office to complete the applicable registration process: Registration with the OCT (4-9016) is required if your study is: an Industry Sponsored Clinical Trial Investigator initiated, regardless of funding, not using the CRC NIH funded, but not using the CRC For registration with the OCT, please add Silvia Muniz on myResearch IRB – under Manage Ancillary Review, no response required Registration with the CRC (4-6900) is required if your study is: Investigator initiated, regardless of funding, using the CRC NIH funded using the CRC Registration with the CCTO (8-0846) is required if the study is: An NCI Cooperative Oncology Group Trial (ECOG, GOG, COG etc) Research will be performed (check all that apply): Inpatient Revised 04.25.19 Outpatient Both → Specify locations:       Costs associated with tests/procedures performed for this research activity will be: Totally reimbursed by study sponsor → identify sponsor       Totally reimbursed by patient’s health insurance Reimbursement by BOTH study sponsor and patient’s health insurance If costs are not reimbursed by either the sponsor or by insurance, how will non-reimbursed costs be covered?       UNIVERSITY HOSPITAL RESEARCH BUDGET The following table must provide detail for all tests/procedures to be conducted for the purpose of the proposed research activity The Clinical Trials Office may be contacted at 4-9016 with questions concerning completing this form Test/Procedure                                                                                     # per Pt                                                                       Revised 04.25.19 P-file                                                                                     Research Charge                                                                                     Multi-year Surcharge 5% 2nd year                                                                       Multi-year Surcharge 5% 3rd year                                                                                     Total Charge                                                                                     Does this study involve the use of pharmaceuticals? NO YES → complete for each pharmaceutical: Generic Name A B C D                         Manufacturer/ Source                         Method of Administration                         Strength                         Dose                         Will the pharmaceutical(s) be provided without cost by the sponsor? YES NO → Are the Pharmacy charges built into the budget? YES NO → if no, Document source of funding:       Indicate type of usage: Inpatient Outpatient Both Indicate specific areas of use: Nursing Units Ambulatory Unit Other (explain):       Will the services of the Pharmacy be used? (required if UH, HSC, Cancer Center, Ambulatory Surgery) NO → If this study is going to an external IRB (CRRI, NCI CIRBs), you must notify lu-ann.kozlowski@stonybrook.edu for additional questions that must be answered and reviewed by SBU’s Research Pharmacy In addition, share package with ‘Research Pharmacy’ YES → Services required from pharmacy (check): label dispense dilute/compound randomize maintain blind complete usage form Provide the names of Authorized Prescribers (other than PI): a       Revised 04.25.19 b       c       repack storage Other (explain):       Does this research require sending identifiable (including coded) subject information to the sponsor, vendor, external collaborating PI, or data coordination center? NO YES → detail the method (e-mail, fax, spreadsheet, website, etc)       If you answer yes to #5, approval of the SBUH-HSC Information Security Officer is required Endorsement of Principal Investigator Submission in myResearch by the principal investigator means (in addition to the IRBrequired attestation) that the information provided in this form is accurate and complete Billing of activities in research vs clinical encounters will be done in compliance with federal and state regulations Endorsement of Ancillary Hospital Departments Approval in myResearch must be obtained from the directors of the following ancillary hospital departments Radiology, Pathology/Laboratory, Pharmacy, and Information Security, as applicable, prior to the commencement of the research activity  Radiology Department (Mark Schweitzer)  Laboratory/Pathology Services (Eric Spitzer)  Pharmacy Services (share with ‘Research Pharmacy’)  Information Security (Matt Nappi – VP of IT & CIO)  HIPAA Privacy Officer (Stephanie Mantione) Endorsement for Certain Activities: NEW effective 10.9.17  Involvement of research-related radiation (share your study with Sean Harling)  Use of surgical pathology or cytology specimens (share your study with James Davis and Jingxuan Liu) Endorsement of Rhona Vainder (Chernoff) or Regina Rigoroso or John Shen: Submission of approval in myResearch by Ms Vainder (Chernoff) OR Ms Rigoroso OR Mr Shen Administration, provides endorsement of the financial/billing aspects of the activity to be conducted at University Hospital facilities With the required approvals above, a signed contract and IRB approval, the research activity may commence Revised 04.25.19 Revised 04.25.19