Miami Valley Hospital Clinical Trial Application Process
Miami Valley Hospital (MVH) utilizes external Institutional Review Boards (IRBs) for the review and approval of all new applications for clinical trials. Investigators must fill out the appropriate forms and submit the documentation to one of the MVH-designated IRBs to secure approval before conducting any research at Miami Valley Hospital. For clinical trials sponsored by the MVH research community, the Wright State University (WSU) IRB will be utilized. The Western Institutional Review Board (WIRB) is approved by MVH and the Clinical Trials Research Alliance (CTRA) for review of industry-sponsored clinical trials.
Please do not send petitions for new studies directly to the external IRB. All submission materials for new research proposals in which Miami Valley Hospital (MVH) is engaged (MVH employees, MVH facilities, MVH students, MVH patients, MVH Health Information, etc.) are to be directed through the MVH Clinical Research Center (CRC).
Contact the MVH CRC if you have any questions or require any assistance.
Obtain the forms required to submit an application to the WSU IRB from the WSU IRB Internet website .
The MVH CRC Intranet Website
The MVH CRC, accessible only from the Premier Health network, maintains an intranet website. The forms and information needed by the investigator for submission of protocols for protocols in which MVH is engaged are available on this website.
Protecting confidentiality of electronically stored data
Premier Health requires that data be stored on a Premier Health file server which provides regular backup and security. Data must NOT be stored on the local C: drive of computers, or any other form of removable media. All data with Protected Health Information (PHI) should be stored in a password protected file whether it is in Word, Excel, Access or some other database. Premier Health IT customer support can assist Investigators with arranging for data storage on a Premier Health file server. The Clinical Research Center (CRC) at MVH has computer workstations that meet these requirements as well as statistical programs to assist with data analysis.
Electronic Medical Record (EMR) Access
Premier Health utilizes the EPIC “inbasket” process to provide EMR access to researchers doing retrospective chart review. This process permits the researcher access to only those patient records specified in the research protocol. Contact the Clinical Research Center (CRC) at MVH for assistance with setting up an “inbasket” account for a retrospective study.
The MVH Human Investigation and Research Committee (HIRC)
The HIRC is a new Medical Staff committee which functions through the MVH Medical Education Department and the Clinical Research Center (CRC). The HIRC reviews research proposals for hospital-specific issues. These issues may include:
- Use of the same patient population for more than one study
- Timing of surveys relative to other activities
- Sufficient support capability, including funding, for studies
- Research oversight and administration.
Both HIRC and IRB approval are required before a study may be conducted at MVH.
Miami Valley Hospital Clinical Research Center (CRC)
Weber Center for Health Education, 6th Floor
One Wyoming St.
Dayton, OH 45409
Fax (937) 208-5075
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