Investigators can participate in many types of research sponsored by a variety of agencies. This section will help define these areas and will provide a high level overview of the steps involved in initiating a clinical trial at WCM/NYP.
Types of Trials
- Therapeutic: involves a new agent or device intended to study the safety and efficacy of the product (i.e. phase I study evaluating an investigational drug)
- Interventional: involves a procedure or intervention that is not an agent or device (i.e. brain scan for research)
- Non-therapeutic/Non-interventional: involves research or review of records where all the events of interest have already happened (i.e. case-control, cross-sectional and cohort studies) or where data is to be collected prospectively (i.e. prospective observational studies and registries in which the data collected derive from routine clinical care)
Types of Sponsors
- Industry: A pharmaceutical or device company
- Sponsor-Investigator: The investigator or institution sponsors the study and may hold the IND or IDE traditionally held by an industry sponsor. In this case the investigator develops a protocol and the investigator or institution is responsible for the conduct of the trial. Investigator Initiated Trials (IITs) can be led by WCM or WCM can be a sub-site of another center’s trial. These trials may be funded by industry, a grant, or a foundation or they may be unfunded. For additional information about IITs visit the Writing an IIT and Submitting an IND/IDE pages.
- Cooperative Group and/or Consortium: A research project or group made up of many investigators from hospitals and academic research centers throughout the United States. A list of WCM/NYP affiliated cooperative groups can be found on our Institutional Information page.
The Study Activation Diagram outlines many of the steps in the process of obtaining approvals and activating a study. The following pages assist in navigating and streamlining the process. The process focuses primarily on the activation of industry sponsored clinical trials and some steps may not be required for other sponsor types. For example, cooperative groups generally provide minimal oversight for the activation process at each local site leaving the responsibility for ensuring compliance to the regulatory process at the local or site level.
To determine whether our site is qualified to participate in a clinical trial; sponsors may wish to perform a Pre-Study Visit (PSV) or Site Qualification Visit (SQV). During this visit, the sponsor or their representative will ask for a tour of the facility. You may also be asked to answer questions about our site. These questions are part of the Feasibility Questionnaire. A template questionnaire can be found in the Researcher’s Toolbox.
The Clinical Study Evaluation Committee (CSEC) is the first step in the study review process. This committee focuses on scientific merit and feasibility. The Institutional Review Board (IRB) provides the second review and approval, focusing on the protection of human subjects. Tips on navigating the CSEC and IRB can be found on the Navigating the CSEC and IRB page. Additionally you may visit the IRB website at Research Integrity. To gain access to the eIRB system, please send an email to firstname.lastname@example.org.
The IRB provides different levels of review based on the risk level of the study. The three categories are as follows:
- Full Board
Once a study is reviewed by the IRB, the study will receive one of the following dispositions:
- Modifications Required
Visit the the IRB page for more information about the review process.
For inquires on the study activation process, contact JCTOoperations@med.cornell.edu.