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.
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.