Investigator Initiated Study Development
Developing a protocol is a process that should be started early and given significant thought and consideration. When designing the study initially, it is important to ensure that the protocol is well-designed from a scientific standpoint: that the research question is well-formulated and that the data gathered will be reliable, valid, and will address the hypothesis. This can be achieved by conducting a thorough literature review and consulting with colleagues with the relevant expertise. Another important factor in embarking on a research project is determining whether it is feasible. In other words, are the resources available to do what is planned?
The Biostatistics team can assist with study design and feasibility and should be contacted early on in the process.
Another element of the protocol development process is writing the protocol and developing the tools and processes to carry out the research. 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.
Some documents you may need for your research include:
- Chart Review Protocol Template
- Drug/Device/Biologic Protocol Template
- Generic Protocol Template
- HIPAA document if not combined with consent form
- Pediatric Assent form
- Required Language for External IRB Consent Forms
- Research Consent Form Template
If you are planning to include non-English speaking participants in your research, please note the following update about utilizing short forms:
If you are considering including the possibility of a Legally Authorized Representative (LAR) in the research consent process, please review the NJ Access to Medical Research Act.
For Animal Research: For templates and forms relevant to animal research, please contact Leigh-Ann Tulleson.
For Biosafety Protocols: For templates and forms relevant to biosafety protocols, please contact Sean Fitzgerald, MPH.
Investigational New Drug (IND) Information:
Information about the Investigational New Drug (IND) process can be found here. 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 (a) an approved drug that will be used off-label (different indication) or (b) a drug that is not FDA approved.
There is a similar process with 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.
Information about clinical trials and required registration can be found here. 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.
If you think your study could be a clinical trial or if you have questions regarding the registration process, please contact Elli Gourna Paleoudis, PhD at Elli.GournaPaleoudis@hmhn.org. 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
For more information, please contact Elli Gourna Paleoudis, Ph.D., Manager, Investigator Initiated Research Program