Many clinical trials require resources from external departments. Each department has a process for obtaining approval for study-specific procedures and utilization of department resources. This section outlines the process for obtaining approval for the most frequently utilized departments.
Clinical and Translational Science Center
The mission of the Clinical and Translational Science Center (CTSC) is to provide an environment that allows optimal use of our considerable multi-institutional assets and the diversity of our patient population to move translational research seamlessly from bench to bedside and to the community. The CTSC acts as a conduit through which essential resources, technological tools and education programs for all partners can be efficiently shared and managed. For more information about and collaborating with the CTSC please visit the website here.
For clinical trials that require the services of the Department of Ophthalmology, contact Susan Herder at (646) 962-4118 or firstname.lastname@example.org and provide the following information:
- PI Name
- Protocol Title
- Study details (anticipated study start date, estimated subject accrual, etc.)
- An outline of the services needed
- Research account # (if known)
- Name of Ophthalmologist (if one has already agreed to be on protocol; if not you can request a list of Ophthalmologists)
The Department of Ophthalmology will review the information submitted for feasibility, assign a dedicated Ophthalmologist and provide the CPT codes needed for HRBAF preparation.
For clinical trials that require the services of the Department of Pathology follow the instructions below.
Tissue Submission Policy: Human tissue removed during a diagnostic or therapeutic procedure must be submitted to the Department of Pathology intact and may not be incised, opened, or damaged in any way, with the exception of surgical waste. Peripheral blood is not considered tissue. All tissue that is not considered surgical waste as defined below must be submitted to the Department of Pathology for initial review unless an exception to the tissue submission policy is requested (such as bone marrow aspirate samples).
Human Tissue Includes:
- umbilical cords
- umbilical cord blood
- bone marrow aspirates
- fine needle aspirates
- cytologic specimens
Human Tissue Excludes:
- Fluids such as blood, urine, CSF, and amniotic fluid at the time of rupture of membranes prior to or during labor
- “Surgical waste” specifically defined as:
- Subcutaneous tissue removed to facilitate wound closure
- Tissues significantly altered or diluted by the procedure such as
* lens phakoemulsifications
* vitrectomy specimens
* liposuction specimens
For new protocols and continuing reviews please submit the following documents to email@example.com.
- PDF of the completed Non-Technical Research Plan (NTRP) in eIRB
- Completed Request for Human Tissue Form
- Informed Consent Form (ICF)
Requesting Tissue from Pathology
- Complete the online form for requesting Pathology Technical Services (New project) from the Translational Research Facility (TRP), available at the Pathology and Laboratory Medicine site.
- Upon receipt, the approved Human Tissue Request Form should be attached in eIRB (Note: Activation of protocols cannot take place until the approved Human Tissue form is attached in eIRB).
- Upon IRB approval, if a TRP account is requested (meaning you require the services of Pathology) click here and complete the Master Request.
- Once you receive an email notification that the master request is completed, submit the IRB approval letter and approved Human Tissue Request Form, with a cover memo (the cover memo should contain the IRB number, TRP number, and PI name) to firstname.lastname@example.org requesting approval of the Translational Research Project.
For additional information regarding the request of human tissue and the use of Pathology Services, click here. (instructions on the bottom of the page)
For clinical trials that require the services of Investigational Pharmacy please follow the instructions below.
For new protocols please submit the following documents:
- PDF of the completed eIRB protocol application
- Completed Use of investigational pharmacy form
- Investigators Brochure (IB)/Package Insert
- Completed FDA Form 1572
Breakdown of pharmacy preparation as follows:
- IV hazardous investigational agent
- Combination of:
- IV hazardous agent (investigational or commercial/SoC infusions administered in Starr3) plus oral non-hazardous/hazardous
- IV non-hazardous agent
- Oral only non-hazardous/hazardous agents
- Combination of IV non-hazardous agent plus oral non-hazardous/hazardous agents
- IDS only dispenses oral agent and IV hazardous agent is prepared/dispensed by clinic pharmacy (NOT Starr-3 infusion center)
Upon receipt of approval from Investigational Pharmacy, submit a copy of the approved Use of Pharmacy Form in eIRB which is required for study activation.
All communications, including weekly subject lists, orders, "Go" notifications, monitoring visit requests, SIV notifications, study activation, amendment notification, IB updates, etc., should be sent to the appropriate list-serv. These communications should be comprehensive and include all relevant study related information. The pharmacists have access to our shared drive, so hard copy communication of protocol, IB etc. is no longer required.
Use of Controlled Substances in Human Subjects Research
The New York State Department of Health requires persons engaged in research, industrial or commercial processes requiring the use of controlled substances in Schedule I to first obtain a Class 7 license and in Schedules II through V to first obtain a Class 4 license. These licensing requirements are in addition to those mandated by the Drug Enforcement Agency. For more information on this requirement please visit the New York State Online Permit Assistance and Licensing site. At this time the WCMC/NYP Investigational Pharmacy holds a Class 4 license.
Research involving controlled substances requires the Principal Investigator and Sub-Investigators to have the appropriate Drug Enforcement Agency Researcher registrations. Please visit the U.S. Department of Justice site for fees associated with the acquisition of and renewal of these registrations. Once the fees are determined they can be incorporated into the study budget.
To determine which schedule investigational agent you will be working with please visit the U.S. Depart of Justice site for the list of controlled substances.
Procedures for obtaining Investigational Pharmacy Approval to receive Schedule II-V Controlled Substances for Human Subjects Research
The institution is required to submit study specific information to the Department of Health upon IRB approval of each study involving Schedule II-V controlled substances. In order to satisfy this requirement, researchers must submit the following documents to the Investigational Pharmacy for each study utilizing controlled substances. These documents must be received and approved by the Investigational Pharmacy before drug can be shipped to the WCMC/NYP Investigational Pharmacy.
Please submit the following documents to email@example.com.
- Completed Section I: Use of Drugs or Biological Agents Form
- Drug Enforcement Administration Registration of the Principal Investigator (Business Activity – Research for the applicable schedule)
- Drug Enforcement Administration Registration of each Sub-Investigator (Business Activity – Research for the applicable schedule)
- Drug Enforcement Administration Registration of the distributor or manufacturer providing the substances
Imaging Data Evaluation and Analytics Lab (IDEAL)
Studies that involve the archiving, transfer, and/or review of images or image-related data derived from diagnostic imaging or image-guided interventions require the use of IDEAL. To request IDEAL services complete the following steps:
- Create an IDEAL account by visiting here.
- Activate your account by contacting firstname.lastname@example.org and providing your CWID, email address and phone number. You will receive an email confirming activation of your account.
- Select “register new study” to add a new project into the IDEAL online request system. You will be prompted to enter relevant imaging information and upload study documentation for the project.
- Complete the IDEAL Research Agreement form (to be completed at time of CSEC Part B submission). This form is required to register the study.
- After the study has been submitted to IDEAL, reviewed by the staff and activated by any external vendors (if applicable), services can be requested. Users will be prompted to register study subject and time point for any request.
- For outside imaging, fill out the IDEAL order form for the associated exam. Bring the outside imaging CD with the appropriate IDEAL order form to IDEAL for archiving into the PACS system.
- If you do not see an option for the required exam, contact IDEAL to have the exam entered into the online request system.
All exams should be entered into the online system before they are to be performed. This will notify the radiology technicians of any requirements for the exam.