A clinical trial is defined as any research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

All eligible clinical trials need to be registered prior to the first patient being enrolled.

Information about clinical trials and required registration can be found here.

Information about Clinicaltrials.gov for researchers and support staff at HMH can be found here.

If you think your study could be a clinical trial or if you have questions regarding the registration process, please contact Elli Gourna Paleoudis, Ph.D. To access the registration system, please go to Protocol Registration and Results System (PRS). To look for registered clinical trials, please go to ClinicalTrials.gov.

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. An IND is required when an investigator would like to conduct a study with an approved drug that will be used off-label (different indication) or a drug not FDA-approved.

A similar process is required for investigational devices. Before a study can be conducted with an investigational device, an Investigational Device Exemption Application (IDE) must be submitted and approved by the FDA. Approval of the application allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data

Writing the protocol and developing the tools and processes to carry out the research are critical to developing a strong research plan. It is important to ensure that the protocol is very clear. Another researcher should be able to replicate the exact same experiment by referring to the protocol document. The protocol also needs to be compliant with the relevant federal and local regulations. Protocol writing support is available to assist with this process.

Protocol Development resources are available to all Hackensack Meridian Health investigators who would like to develop their own research projects. Our team guides investigators through the conception, design, implementation, and manuscript preparation of novel clinical and basic research, including Phase I-IV clinical trials, translational research studies, and outcomes research projects.

First-time investigators are encouraged to contact the Office of Research Administration in the very early stages, regardless of the status of the project at the time. Our team is experienced in working with researchers to transform an idea into a well-designed research protocol that is consistent with local and federal regulations. We also provide assistance with the design, conduct, or analysis of an existing study.

Providing some basic information at the onset will enable our team to better support the investigator and expedite the study initiation, so it is encouraged to have the following information at the first consultation:

• Type of project (e.g. clinical trial, retrospective chart review, etc.)
• Research area of interest
• Research question, research objectives, and/or hypothesis (if applicable)
• Study Overview (if applicable)
• Protocol Draft (if applicable).

To facilitate the process, investigators are advised to utilize the protocol templates.

To request assistance with a new project, please complete the request form. It will be reviewed, and a team member from the Office of Research Administration will reach out to you to schedule a call or a meeting within three to five (3-5) business days.

To edit the document, go to File > Make a Copy. Once the document is copied into your drive, you will be able to edit it.

• Chart Review Protocol Template
• Drug/Device/Biologic Protocol Template
• Generic Protocol Template
• HMH Information Sheet Template
• Pediatric Assent form
• Required Language for External IRB Consent Forms
• Research Consent Form Template