Instructions: the New Study Feasibility and Pre-Award Processes Activation: Principal

Instructions: The New Study Feasibility and Pre-Award Processes Activation: Principal Investigator Review and Approval form is completed by the Principal Investigator (PI) or designee.The following applicable documents should be included for submission to the Clinical Research Service (CRS) with this form: (1) Study Protocol; (2) Preliminary Budget; (3) Preliminary Contract; and (4) Applicable Forms/Regulatory Documents (Consent, IND/IDE, NDA, COI, etc.). Print form and verify that all applicable signatures/sign-offs have been obtained. Scan form into PDF format and submit to the CRS via email along with all applicable documents as attachments. Retain hard copy of this form in the study binder.

Section1: Study Information
Date: ______PI Name: ______Dept. ______Division: ______
Email: ______Phone: ______Fax: ______
PI Location:______
Complete Protocol/Study Title:______
□Industry Initiated □PI Initiated
Type of Study□Clinical Trial PHASE ? BELOW □Registry □Observational □Chart Review
□Epidemiological □Quality Assurance/Improvement □Other (specify):______
Phase of Study □I □II □III □IV
□Post - Market □Other: □N/A
Funding Source
□Industry - Specify Sponsor: ______□Departmental Funding □Federal Grant □Other Grant (specify):______
□Private Funds □Foundation Funding □No source of Funding □Other Funding (specify):______
Estimated No. of Subjects: ______Enrollment Start Date: ______Enrollment End Date:______
Section 2: Study Location / Yes / No / N/A
Study is: □Single Center □Multi-Center □I am the lead PI of a multi-center study
Indicate the site(s) to be used in this study:
□ Ambulatory Care Center
□ Arthur Smith Urology Center
□ Stern Family Center for Extended Care & Rehabilitation
□ Chiari Institute
□ Cohen Children’s Medical Center (CCMC)
□ Huntington Hospital
□ The Feinstein Institute for Medical Research (FIMR)
□ Franklin Hospital Medical Center
□Huntington Hospital
□North Shore University Hospital (Syosset)
□Southside Hospital
□Staten Island University Hospital – North
□Staten Island University Hospital – South / □Lenox Hill Hospital
□LIJ Medical Center
□Manhattan Eye Ear and Throat Hospital
□ Monter Cancer Center
□ Nassau University Medical Center
□ North Shore University Hospital (Forest Hills)
□ North Shore University Hospital (Glen Cove)
□ North Shore University Hospital (Manhasset)
□ North Shore University Hospital (Plainview)
□NSUH Dentistry (400 Community Drive)
□The Zucker Hillside Hospital
□Private offices (specify): ______
□Other (specify):______
Indicate the building(s) and room number(s) of each location where the study will take place:THIS WILL OCCUR W/EACH SITE ABOVE
Building:______Room number: ______
Building:______Room number: ______
Building:______Room number: ______
Does the study involve external sites or other IRBs outside of NSLIJHS?
If no, proceed to Section 3: Principal Investigator & Study Personnel
If yes, proceed to next question. / □ / □ / □
List external sites where research will be conducted.
______
______
______
Do you have the other site(s) IRB approval?
If yes, please submit approval with this form. / □ / □ / □
If the site has not issued IRB approval, is the protocol currently under IRB review?
If yes, when is approval anticipated? ______/ □ / □ / □
For sites who do not currently have IRB approval, list contact information of the IRB at each site:
IRB: ______Contact: ______Email:______
IRB: ______Contact: ______Email:______
IRB: ______Contact: ______Email:______
Have sites been chosen that can access the target populations and have a realistic likelihood of recruitment success?
Have you considered the impact of potential unbalanced enrollment across sites?
Are conditions under which a site may be terminated been specified?
Please describe how you will ensure that all sites will adhere to the protocol.
Please explain how data will be managed at multiple sites.
Section 3: Principal Investigator & Study Personnel Yes No N/A
Refer to NSLIJHS institutional policy and FDA Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects at
Is there qualified research staff to conduct the study? / □ / □ / □
Provide the following information:

1. Study Coordinator (SC) for this protocol:

______

1. Study Coordinator’s contact information

Email: ______
Phone: ______

1. Attach the current Curriculum Vitae of the Principal Investigator and Study Coordinator that will allow the reviewer to determine whether the individual has the qualifications to conduct and coordinate this protocol.

Do you have appropriate time and scheduling availability to devote to the overall supervision of the trial? / □ / □ / □
Will the study involve on- call time or coming in after hours for enrollment? / □ / □ / □
Does the study require additional PI oversight? (i.e. vacation coverage, time outside of business hours, etc.) / □ / □ / □
Section 3: Principal Investigator &Study Personnel
Study
Personnel / Role
on
Project / Department
Affiliation
(Hospital/Facility) / Division / Licensure / NSLIJHS
Employee
Y/N / Access to Study Drug, Biologic and/or Investigational Product?
Y/N / COI
Form
Y/N / REQUIRED
EDUCATION / ADDITIONAL
EDUCATION
Human
Subjects
Training
(CITI)
Date* / Researcher
Registration
Date* / COI
Training
(CITI)
Date*

*The researcher registration date is the date the person signed the researcher registration form. The Human Subjects Training CITI date is the date of most recent completion of the CITI tutorial program for the basic or refresher human subject’s research course. The COI Training CITI date is the date of most recent completion of the Conflict of Interest Training Course.

Section 4: HIPPA/Data Security Compliance / Yes / No / N/A
The HIPAA Security Rule requires protection of ePHI that is created received, used, or maintained by a covered entity. Please indicate the protections planned for the security of electronic research data containing PHI:
Refer to NSLIJHS institutional policy and U.S. Department of Health and Human Services National Institutes of Health HIPPA Privacy Rule: Information for Researchers at
Indicate the type of electronic program(s) you plan to use that will contain research data with PHI (check all that apply):
□Spreadsheets or documents (Excel, Word, pdf, etc.)
□Databases or programs (commercial or in-house software, internet/web-based, etc.)
Name of system(s): ______
□Other (specify):______
Do maintain (or anticipate maintaining) a database over 500 individuals? □Yes □No
Do you maintain social security numbers (SSNs)? □Yes □No
If yes, describe protections in place to protect this information:
Note: SSNs should be collected only if necessary ( tax requirements, etc.)
Indicate where electronic programs containing PHI or ePHI will be stored, backed-up or maintained (check all that apply):
□Health system’s server
Note: Data stored to a local computer hard drive or desktop ( C drive or “C:\”) is not considered to be stored to the Health System’s server.
□Outside the health system ( cloud-based server by vendor, other institution or entity, etc.)
Note: A Business Associate Agreement must be in place with any external individual or organization providing services that will receive and/or use PHI.
□Other (specify): ______
Confirm that the following protections are in place by checking the boxes.
Note: all of these are required. For items a to c, if you are using Microsoft Office applications please see guidance for additional information):
A)□Access is controlled ( password protection, designated levels of access, termination of access, automatic log-off after inactivity)
B)□Plans for tracking/monitoring access activities
C)□Plans for emergency access, disaster recovery or preventing improper alteration/destruction ( restoration of data loss in event of natural/manmade disasters, system failure or outages)
D)□Access is limited to authorized personnel dedicated by the PI ( unique user ID, temporary access to external monitors/auditors)
E)□Physical access is controlled to prevent unauthorized access; tampering or theft (locked doors, access badges, etc.)
F)□Workstation is secured (protected from public areas/view using privacy screens, placement of monitors, etc.)
G)□Data backed-up and stored on health system server or secure external server
H)□Encrypt data when transmitted (via email/web, CD/DVD, thumb drive, etc.) □NA
I)□Encryption of removable media containing data (laptops, portable hard drives, flash/thumb drives, etc.) □NA
J)□Plans for secure disposition/disposal/re-use of data/hardware
Will data be submitted to the FDA? / □ / □ / □
Section 5: Enrollment Potential Yes No N/A
What is the estimated number of participants that your site has the capacity to screen, enroll and follow-up with?
Are the inclusion criteria too narrow, such that you will have unusual difficulty finding people who meet eligibility criteria? / □ / □ / □
Do you anticipate that you can enroll the subjects needed within the timeframe specified? / □ / □ / □
Have relevant aspects of the methodology including screening, recruitment, assessment, randomization procedures, treatment and experimental measures been piloted?
If yes, please briefly describe outcomes. / □ / □ / □
Will recruitment need to occur from external sources?
If yes, please describe: ______/ □ / □ / □
Will enrollment compete with other studies seeking the same patients?
If yes, provide justification of how you will meet study objectives. / □ / □ / □
Do you have a detailed plan for community outreach?
If no, are you interested in assistance in developing a community outreach plan?NICE FOR TRACKING / □ / □ / □
Will the sponsor pay for screen fails? / □ / □ / □
Will participants be compensated? / □ / □ / □
Will any of the following be reimbursed?
□Travel □Meals □Overnight stays □Other (specify): ______
If a drug study, will the drug be available to the participants after the study? / □ / □ / □
Section 6: Sponsor / Clinical Research Organization Yes No N/A
Do you have previous experience with the sponsor? / □ / □ / □
Has previous experience with the sponsor been satisfactory? / □ / □ / □
If no experience with the sponsor has the sponsor’s reputation been validated with colleagues? / □ / □ / □
CRO Name (if applicable): ______
How often will the monitor visit? □Monthly □ Quarterly □UNK □ Other – Please describe:______
Total estimated number of hours: ______hours
Section 7: Budget & Sponsor Obligations Yes No N/A
Are there standard of care procedures listed in the study that will be billed to insurance? / □ / □ / □
Section 8: Operational Feasibility Yes No N/A
FDA regulations require institutions conducting research to review the adequacy of the research site. For guidance refer to:

Do you have all the resources you need to conduct the study?NICE FOR CRS TRACKING
If “no,” and any of the following services are needed, please contact the Clinical Research Service at
516-562-0340, as they may be able to assist you:

• Nurse and/or coordinator time/services
• Clinical procedures: EKG, venipuncture, vital signs, etc.
• IRB submissions
• Site visits with sponsor/monitor
• Drug /investigational agent administration
• Specimen collection, processing, storage, maintenance and/or shipment

/ □ / □ / □
Is necessary equipment, including ancillary service equipment in other hospital clinical departments, available?
If yes, please list the equipment: ______/ □ / □ / □
Will coordination with other departments/services be required for study visits or procedures? / □ / □ / □
If yes, please list those departments:
□Laboratory
□Phlebotomy □Labs processed here
□Shipping □Freezer storage
□Dry Ice □Other: ______
□Pathology
□Specimen shipping/handling □Other:
□Radiology
□X-ray □CT scan □MRI
□Copies of films □Other: ______
□Endoscopy □OR / recovery room □In-patient room □EKG □Infusion suite
□Cardiology
□Echo □Stress test □EKG □Cardiac cath lab
□Other: ______
□Ambulatory/Day Surgery
□Other: ______
□Investigational Drug Service
□Dispensing □Mixing/compounding ( chemo) □Storage □Other: ______
Does the research staff know how to schedule procedures/tests that are specific to the research study? / □ / □ / □
Are there any medications to be given prior to research tests/procedures? / □ / □ / □
Do you anticipate needing consent translations? / □ / □ / □
If other clinical services are required (i.e., laboratory, consults from other departments, Emergency Department, etc.) list them and obtain chair approval for each. Please complete Section 13: Additional Approvals.
Section 9: Supplies & Equipment Yes No N/A
FDA regulations require institutions conducting research to review the adequacy of the research site. For guidance refer to:

Will electronic or remote data capture be used? / □ / □ / □
If so, will the sponsor provide hardware/software and training? / □ / □ / □
Is access to emergency equipment readily available? / □ / □ / □
What will the sponsor supply?
□ Case Report Form (CRF) □ Source documents/templates □ Electronic consent □ Packaged lab kits
□ Pre-paid shipping □ Other: ______
Section 10: Management & Control of Drug/Biologic/Investigational Product Studies Yes No N/A
Refer to NSLIJHS institutional policy and FDA regulations at:

Does the study involve an investigational drug, chemical, biologic, nuclear, controlled substance and/or investigational product/substance?
If no, proceed to Section11: Management & Control of Investigational Device Studies
If yes, please specify:
______□Chemical □Biological □Nuclear □Controlled □Other
______□Chemical □Biological □Nuclear □Controlled □Other
______□Chemical □Biological □Nuclear □Controlled □Other
Specify where the chemical, biological, nuclear and/or controlled substance will be used.
______/ □ / □ / □
Does this study require an IND?
If yes:
IND #: ______
IND held by: ______/ □ / □ / □
IND exempt? / □ / □ / □
Off – label use? / □ / □ / □
Is the investigational product being supplied by the sponsor? / □ / □ / □
Are study drugs, biologics and/or investigational products managed by a NSLIJHS Pharmacy?
If no, please describe how the drugs, biologic, and/or investigational products will be prepared, managed, stored & secured. / □ / □ / □
Will study drugs, biologics and/or investigational products be prepared or manufactured in NSLIJHS research labs?
If yes, specify lab: ______
If no, please describe where the products will be prepared or manufactured. / □ / □ / □
Specify how records for control of the drug/biologic will be recorded.
□The sample Drug/Biologic Accountability Log on the Human Research Protection Program website will be used.
□The Drug/Biologic Log provided by the Sponsor will be used (attach and submit with this form)
□Other (specify): ______

• Institutional policy requires Lab Safety/Facility approval for the use of all chemical, biological and nuclear substances. Please complete Section 13: Additional Approvals.

Section 11: Management & Control of Investigational Device Studies Yes No N/A
Refer to NSLIJHS institutional policy and FDA regulations at:

Does this study involve the use of an FDA approved device?
If no, proceed to Section 12: Clinicaltrials.gov
If yes, specify device: ______/ □ / □ / □
Does this study require an IDE?
If yes:
IDE #: ______
IDE held by: ______/ □ / □ / □
IDE exempt? / □ / □ / □
Will the investigational device be manufactured at a NSLIJHS facility?
If yes, identify facility/location: ______
If no, please describe where the device will be manufactured. / □ / □ / □
Is the device electronic?
If so, has the NSLIJHS biomedical engineering been notified? / □ / □ / □
□ / □ / □
Specify how records for control of the device (or device stock) will be recorded.
□The sample Device Accountability Log on the ORC website will be used.
□The Device Log provided by the Sponsor will be used (attach and submit with this form)
□Other (specify): ______
Describe where the device will be stored: ______
Please describe the process for handling faulty/damaged devices. If the information is contained within the protocol, you may refer to the protocol pages.
Section 12: Clinical Trials.gov
Public Law 110 – 85 requires registration of clinical trials. The International Committee of Medical Journal Editors (ICMJE) also requires registration of clinical trials in order for results to be published in member biomedical journals. Clinical trials are required to be registered before the enrollment of the first subject, but not prior to IRB approval.
Refer to for guidance:

NSLIJHS Policy GR020 Requirement for Registration of Clinical ResearchStudies

Please select one of the following:
□This is not a clinical trial; registration is not required
□Registration pending
□ClinicalTrials.gov “NCT” number for this trial: ______
Section13: Additional Institutional Approvals Required Prior to Initiating Conduct of Research Yes No N/A
Does this study require additional approvals?
If yes, proceed. / □ / □ / □
Is this a Tissue Acquisition Program (TAP) Protocol?
If yes, has COPP approval been obtained?
If yes, attach COPP approval letter.
COPP approval date: _____/_____/_____
If no, explain current state. / □ / □ / □
□ / □ / □
Is this cancer research that requires approval from the Cancer Services Research Review Committee (CSRCC)?
If yes, has CSRRC approval been obtained?
If yes, attach CSRRC approval letter / email.
CSRCC approval date: _____/_____/_____
If no, explain current state.
All Adult and Pediatric Cancer Studies must be approved by the CSRRC prior to submission to the IRB. (This is not relevant for Staten Island University Hospital or Huntington Hospital) / □ / □ / □
□ / □ / □
Is this an Emergency Medicine study that requires approval from the Emergency Medicine Research Committee (EMRC)?
If yes, has the EMRC approval been obtained?
If yes, attach approval letter.
EMRC approval date: _____/_____/_____
If no, explain current state.
All NSUH and LIJ Emergency Medicine studies must be approved by the EMRC prior to submission to the IRB. / □ / □ / □
□ / □ / □
Is Radiation or Radioactive Material(s) being used for reasons other than clinical care?
If yes, has Radiation Safety Officer approval been obtained?
If yes, attach approval letter.
Radiation Safety Officer approval date: _____/_____/_____
If no, explain current state. / □ / □ / □
□ / □ / □
Does this study involve the use of an investigational drug?
If yes, has the Pharmacy & Therapeutics Committee approval been obtained?
If yes, attach approval letter.
Pharmacy & Therapeutics Committee approval date: _____/_____/_____
If no, explain current state. / □ / □ / □
□ / □ / □
Does this study involve the use of materials requiring approval from the Institutional Bio-Safety Committee
( biohazards, recombinant DNA)?
If yes, has IBC approval been obtained?
If yes, attach approval letter.
IBC approval date: _____/_____/_____
If no, explain current state. / □ / □ / □
□ / □ / □
Does this study involve chemical, biological and/or nuclear substances?
If yes, has Lab Safety/Facility approval been obtained?
If yes, attach approval.
Lab Safety/Facility approval date: _____/_____/_____
If no, explain current state. / □ / □ / □
□ / □ / □
Does this study involve additional clinical services (i.e. laboratory, consults from other departments, Emergency Department, etc.)?
If yes, has department chair approval been obtained?
If yes, attach approval letter.
Department Chair approval date: _____/_____/_____
If no, explain current state. / □ / □ / □
□ / □ / □
Section 14: Investigator’s Responsibilities Checklist

The following are the minimum responsibilities of Principal Investigators conducting research at NSLIJ Health System.

Investigators conducting research subject to FDA jurisdiction and who are also the sponsors of the research (“Sponsor –investigators”) have additional responsibilities and should look at the guidance on Investigator Initiated Multi Center research at Sponsor-investigators must comply with these additional requirements.