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TriHealth Hatton Research Institute

Scientific Review

Scientific Review

Oncology
Cardiovascular
Perinatal
Nursing

Forms can be found in the Clinical Research Toolbox.

Oncology Scientific Review

The Oncology Scientific Review Committee (OSRC) meets the first Wednesday of each month and is only required for Principal Investigator (PI) Initiated Studies. The Principal Investigator is required to attend this meeting and present a brief summary of the protocol.

  • Deadline for submission is 10 days prior to the meeting.
  • Submissions should be sent to the OSRC Coordinator.

Items needed for submission:

  • OSRC application form
  • Protocol

Be sure your submission includes:

  • Name of principal investigator (PI),
  • Expected duration of study
  • Expected accrual to the study at each of the sites associated with TCI
  • Objective evidence for expected accrual
  • Indication if eligibility criteria overlap with other open protocols.

To be considered for review by OSRC, each protocol must include:

  • Scientific rationale with appropriate supporting references to the medical literature
  • One or more clearly stated scientific aims
  • Clearly stated protocol eligibility criteria
  • Clearly stated treatment plan
  • Clearly stated study endpoint(s)
  • Data forms to be used, copies.
  • Valid statistical design and analysis where appropriate (A Hatton Research Institute biostatistician is available for consultation with PIs for protocols which require statistical design or revision.)

Submissions that do not meet the criteria above will be returned to the PI. Such protocol can be re-submitted, once consistent with above criteria.

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Cardiovascular Scientific Review

The Cardiovascular Scientific Review Committee (CVSRC) meets the second Monday of the month. Review is required for all studies (Sponsored, Prospective or Retrospective PI Initiated Studies). The Principal Investigator is required to present the study at this meeting for discussion.

The Clinical Research Manager will send study documents to the CVSRC members the Friday before the meeting for review. Items needed for review:

  • Protocol
  • Budget

The meeting will be cancelled if there are no new studies to review.

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Perinatal Scientific Review

The Perinatal Scientific Review Committee (PSRC) meets the second Wednesday of each month (5:00 pm). Review is required for all studies (Sponsored, Prospective or Retrospective PI Initiated Studies). The Principal Investigator is required to attend this meeting and present a brief summary of the project.

Deadline for submission is noon ten business days prior to the monthly meeting.

The committee can only review two studies per meeting.

Items needed for submission:

  • Protocol
  • Data Collection Sheets, if applicable
  • PowerPoint presentation
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Nursing Scientific Review

The Nursing Scientific Review takes place at Nursing Research Council which meets the second Friday of the month. Review is required for all studies (Sponsored, Prospective or Retrospective PI Initiated Studies). The Principal Investigator is required to call into the meeting to present the study for discussion.

Items needed for review:

  • Protocol
  • Data Collection Sheets, if applicable

Deadline for submission is noon the Friday prior to the monthly meeting.

 

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