Institute of Healtcare Innovation

Investigators: Clinical Research Resources and Forms

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For MWU Faculty and Staff

Clinical Research / Clinical Trials

The Institute for Healthcare Innovation (IHI) supports human and veterinary patient (subject) research, including documentation and compliance for interventional and observational studies.  The IHI is responsible for the oversight and management of MWU’s regulated clinical studies per MWU Policy # 407.

Important: Faculty investigators should meet with the IHI before starting a clinical study.  The IHI will determine the IHI’s level of involvement, logistics, and provide the Principal Investigator (PI) forms and guidance documents that are specific to the type of clinical study being contemplated.

IHI Categorization of Studies:  Studies range from simple to complex depending a variety of factors.  As such, the IHI categorizes each study based on the following general criteria:

  1. Regulatory Status: Regulated by FDA, FDA-CVM, USDA-CVB or unregulated
  2. Type of Study: prospective interventional or observational or retrospective
  3. Location: Intramural (MSC, EI, DI, AHI) or external (remote hospital / clinic)
  4. Subjects: Human or veterinary
  5. Funding: Industry sponsored, investigator initiated, government funded, etc.

Based on the above, the IHI determines the necessary agreements, documentation, authorizations, and resources (facilities, equipment, personnel, etc.) needed for a particular study.

Clinical Study Support: The IHI works in three phases, generally described as follows:  

  1. Pre-Enrollment: The IHI works closely with the Principal Investigator (“PI”), Office of Research and Sponsored Programs, Business Services and Office of General Counsel to ensure the appropriate agreements, authorizations, accounts, support personnel, and documents are in place. In addition, IHI serves as the liaison for studies funded by pharmaceutical or medical device companies.
  2. Enrollment: The IHI provides full clinical research support for the PI, including study coordinators to manage patient consenting and visits, monitoring visits, and other study related activities.
  3. Post-Enrollment: After the study is completed, the IHI manages the study closeout with the Sponsor, study document archiving, regulatory audits, and other post-enrollment requirements.

Q&A

What Studies Must Involve the IHI?  Any study which is regulated by a State or Federal agency, such as Phase I-IV human studies or pivotal target animal efficacy studies under the purview of the Food and Drug Administration or Department of Agriculture. 

Are All Clinical Studies Managed by the IHI?  No. Certain studies, such as retrospective chart reviews, case reports, or certain types of investigator initiated trials may not be managed by the IHI. 

What Research Does Not Involve the IHI?  Basic (bench) research, retrospective chart reviews, case reports, or lab animal studies.

 

DOCUMENTS:

Below are several documents that may assist the PI in clinical research.  This list is not all inclusive and other forms or documentation will be furnished to the PI during the course of a study.

Clinical Study Feasibility Form: Assists in determining the feasibility of conducting a clinical trial.

Clinical Research Approval Form: Summary document which obtains the authorizations for performing certain types of clinical studies

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