- Find a Mentor
The first step that you will need to take as an investigator is to identify a faculty mentor. This person may not be in your department or discipline; the key is that your mentor has the time and interest in helping you with your research project. You should connect early and throughout the project with your mentor. We recommend scheduling standing meetings to discuss any issues that come up along the way. Check with your program director, education coordinator or department administrator to get connected with a mentor. If you cannot find a mentor, ask us, we can help.
- Design Your Study
Write your study protocol using IRB Policy Submission of New Human Subjects to the IRB as a guide, and for your consent form use the following resources: IRB Policy General Consent Requirements and Templates for Consent Documents. Always have your protocol, plans and data. Always have your protocol, plans and data collections forms developed prior to entering your project in to the electronic IRB system.
Begin the budget process before submitting for funding, otherwise you may not request enough money to complete the study. If your study involves patient care, it is crucial to include your research finance specialist in the budget development process to help you identify the correct hospital charges that will be billed to your study.
If you need help developing a grant or identifying a funding source, contact ClinicalResearch@UHhospitals.org, or the Office of Research Administration at Case Western Reserve University at firstname.lastname@example.org and ask for a recent list of open awards.
- Study Feasibility
Regardless of whether you are designing your own study or considering one sponsored by an industry partner, the protocol must have a solid hypothesis and good scientific design, have scientific and ethical merit, and be financially feasible. There must be resources sufficient to conduct the study. The Research SOP SP201: Protocol Feasibility Assessment provides a process that must be followed prior to IRB approval. This process involves a query of the number of patients available to enroll in your study and a checklist of questions helpful to you in thinking through feasibility issues. Departmental review is an IRB requirement, and your departmental chair is a good source of advice and counsel also.
Identify a mentor early on and one or more co-investigators, and to work with a statistician. Your collaborators can help you nail down subject inclusion/exclusion criteria, data collection tools and plans, and clarify primary and secondary outcomes. Your statistician will assist with a sample size calculation and plans for data analysis to make sure you have a reasonable chance of answering your study question. Contact your department’s administrator or education coordinator to help you identify the statistician for your department.
A well thought out recruitment plan is needed. You will need access to your population of interest, which means specific permissions if you do not provide direct clinical care to potential subjects. If involved, intensive care units must provide a letter of support to the investigator. Also keep in mind that other studies may compete for the same patient population. Our feasibility process will help ensure that there are enough subjects meeting eligibility requirements to assure adequate enrollment. For example, if you hope to interview expectant women about their birthing plans you will need to know the approximate number of prenatal visits at your planned recruitment site.
For industry-sponsored studies, plan to work directly with the Pre-Award Grants and Contracts team to execute any legal documents. Please don’t sign anything without first checking with Pre-Award, who works closely with the Legal Department.
Contact us at CRCFeasibility@UHhospitals.org with questions or concerns.
Investigational Drug Service (IDS) Support
The UH Department of Pharmacy Services provides Investigational Drug Service (IDS) support, including procurement, inventory, and dispensing of investigational and non-investigational drugs for research protocols across the UH system. If you are conducting a clinical research study at UH CMC or one or more of our community hospital or ambulatory sites, you will need to ensure that you plan for and understand how your investigational product (IP) will be procured, inventoried, and dispensed considering (consistent with standard operating procedures in compliance with drug storage temperature monitoring, and overall study and IP management oversight) that each site may require different processes to accommodate limitations. See UH System Policy MM-4 Investigational Products and the UH Clinical Research SOP Manual for more information.
Schedule an IDS Consultation
Please send an e-mail to IDS@UHhospitals.org to request an IDS Consultation as you plan for this integral part of your research study.
Department Level Training
Some departments may require you to have specific training. Your department administrator can assist in determining any department-specific training or policies that you need to know.
UH offers a wide variety of educational and training courses for our investigators and study teams. These can be found in our course catalog.
Our most popular courses are offered live and remotely through Web-ex, while many others are upon request or online. Any course can be customized for your group and scheduled at times that work for you. You can contact us at ClinicalResearch@UHhospitals.org.
All Investigators are required to complete the Collaborative Institutional Training Initiative (CITI), which grants Human Subjects Protections Certification. This certification enters individuals into the Case Western Reserve University Continuing Research Education Credit (CREC) program. In order to maintain certification, 12 CRECs are needed every three years.
Find out more at Case.edu. It is recommended that all investigators complete Investigator Training.
We look forward to helping you get started with your research and throughout the course of your study.