I don’t have any research experience. Can you tell me how to get started?
We provide you with all of the tools and support services you need to become an investigator. Contact us to discuss your concerns. In the meantime, some specific initial considerations are included below:
- We coordinate your training through our subscription with CITI, or we make recommendations for other online and/or on-site training programs.
- It is required you have a study coordinator.
- It is suggested that sites have a portable EKG machine or a laptop computer that has an EKG software package installed.
When you get your first study:
- Start slow. Enroll a couple of patients and then pause until you have your first monitoring visit. This will ensure your processes and duties are being performed correctly. Once you know you are on the right path, enroll a few more.
- Adhere to data entry and query resolution timelines that will be set at each study’s start.
- Be a very present investigator. Research is not a side business, and the drugs and devices that are being studied are investigational. Patients need close supervision. Having strong principal investigator oversight is essential to ensure patient safety.
Does my study coordinator have to be a nurse?
No, it is not required that your study coordinator be a nurse, although a clinical background is helpful. Investigators are able to delegate study tasks, provided the coordinator has been trained and the duties being delegated are within reasonable scope.
How much will it cost me to do a study with Frenova?
There is no cost to the investigator. Investigators are paid by Frenova with the per patient budget. The budget is built using the schedule of assessment in the study protocol for the procedures that must be completed at the various study visits. It is prorated according to patient participation.
What are common characteristics of successful research groups?
The most successful practices recognize that research is not a hobby or side job. In these practices, investigators are allocated research time, all members of the medical group help to screen potential patients for studies, and research is discussed at medical meetings as well as at governing body meetings.