CRS Categorization of Studies: Studies range from simple to complex depending on a variety of factors. As such, the CRS categorizes each study based on the following general criteria:
- Regulatory Status: Regulated by FDA, FDA-CVM, USDA-CVB or unregulated
- Type of Study: prospective, retrospective, interventional or observational
- Location: Intramural (MSC, EI, DI, AHI) or external (remote hospital/clinic)
- Subjects: Human or veterinary
- Funding: Industry sponsored, investigator initiated, government funded, etc.
Based on the above, the CRS determines the necessary agreements, documentation, authorizations, and resources (facilities, equipment, personnel, etc.) needed for a particular study.
Research Study Types:
Investigator Initiated Studies, Pilot Studies, and Unregulated Studies: For unregulated studies, CRS provides study services tailored to the investigator’s needs. CRS can assist with study document preparation (informed consent forms, study protocols, case report forms, recruitment plans), IRB/IACUC applications, and providing research coordinator support. CRS manages and supports the entire process, from pre-enrollment through post-enrollment (including regulatory if needed).
Clinical trials- Regulated Studies (i.e., FDA): Study timelines are generally categorized into three phases. Below is an overview of support CRS can provide:
Pre-Enrollment Phase (Start-up):
- Conduct study feasibility
- Review sponsor protocols & budgets
- Manage site qualification & initiation visits
- Manage study documentation & approvals
- Prepare investigator documentation
- Review, negotiate, and coordinate the execution of clinical research agreements
- Provide research coordinator support for patient consenting, screening, visits, etc.
- Provide regulatory and QA support
- Manage monitoring and close-out visits
- Study invoicing and subject payments
- Close out visits
- Ensure appropriate data and documentation archiving
- Prepare for and manage regulatory inspections
Documentation: CRS reviews, manages, records, and/or processes a range of study documentation including, but not limited to the following.
- Term sheet or letters of intent
- Confidentiality agreements
- Clinical trial agreements
- Investigator agreements
- Data use and material transfer agreements
- Financial disclosure and conflict of interest
- Site selection surveys
- Protocols and study designs
- Informed consent and case report forms
- Recruitment & quality assurance plans
- Delegation of authority log
- Investigational product logs
- Investigator docs (Form 1572, CVs, ..)
- Promotional materials
External Clinical Research and Site Management: CRS supports a variety of studies with external investigators, hospitals and clinics where these activities serve to further integrate Midwestern University with external partners, diversify our research program, and incorporate MWU faculty and students where appropriate