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.. Registration of Activity Any research activity conduct

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:      

1 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)

3 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 P-file Research Charge

Multi-year Surcharge 5%

2nd year

Multi-year Surcharge 5%

3 rd year

Total Charge

4 Does this study involve the use of pharmaceuticals?

NO YES  complete for each pharmaceutical:

Generic Name Manufacturer/

Source

Method of Administration

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: Indicate specific areas of use:

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):

dilute/compound complete usage form Other (explain):       Provide the names of Authorized Prescribers (other than PI):

a       b       c      

5 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 IRB-required 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