ࡱ> #` =bjbjmm X"vvvvbbb8KNv!L""&"$<&D<(QJSJSJSJSJSJSJ$MhhO|wJ]<x$"$"<<wJvv"&"RJ@@@<jv"v8"QJ@<QJ@@:E,v=F"B _TbO=E uHJ0KERO=O=FO=F8((+@,<-(((wJwJ@^(((K<<<< vvvvvvJ  Instructions for Completion of Form 1 All research activity must be reviewed and approved prior to initiation through the Office of Medical Research by the Chief Medical Officer of The Regional Medical Center. This document guides investigators through the application process. Submissions to the Office of Medical Research must contain all required materials. Incomplete submissions will not be considered. For questions about research at The MED, please contact the Office of Medical Research at 545-7453.  Title of Project: FORMTEXT  IRB#:  FORMTEXT  IRB Approval Date:  FORMTEXT      Principal Investigator (P.I.):  FORMTEXT  Position (please check): UT Faculty  FORMCHECKBOX  Fellow  FORMCHECKBOX  Resident  FORMCHECKBOX  Student  FORMCHECKBOX  Other:  FORMTEXT  Is PI credentialed at The MED?:(please check) YES  FORMCHECKBOX  NO  FORMCHECKBOX  (See page 2 for requirements)UT College:  FORMTEXT   Department: FORMTEXT  Address:  FORMTEXT  City:  FORMTEXT  State:  FORMTEXT  Zip: FORMTEXT  Phone:  FORMTEXT  Fax:  FORMTEXT  Email: FORMTEXT  Study Coordinator:  FORMTEXT   Phone: FORMTEXT  Fax:  FORMTEXT  Study Coordinator Email:  FORMTEXT  Type of Study (please check): Investigation with human subjects and/or tissue  FORMCHECKBOX  Exempt  FORMCHECKBOX  Other/Describe:  FORMTEXT  Project is funded: YES  FORMCHECKBOX  NO  FORMCHECKBOX ; If Yes, Funding Source/Sponsor:  FORMTEXT  Sponsor Contact / Representative:  FORMTEXT  Sponsor Contact Phone #:  FORMTEXT  Email:  FORMTEXT  Study Site(s) (please check): MED  FORMCHECKBOX  MEDPLEX (MED clinics)  FORMCHECKBOX  HEALTHLOOP Clinic(s)  FORMCHECKBOX  Other:  FORMTEXT  Are there any services for which The MED will not be reimbursed? (please check) YES  FORMCHECKBOX  NO  FORMCHECKBOX Services will be purchased from The MED (please check) YES  FORMCHECKBOX  NO  FORMCHECKBOX If Yes, Request For Research Rates form has been submitted: (please check) YES  FORMCHECKBOX  NO  FORMCHECKBOX  If services involve interpretation of tests by specialist physicians, e.g. EKG, X-Rays, etc., provisions are in place to prevent patient from being billed (please check) YES  FORMCHECKBOX  NO  FORMCHECKBOX  Do you plan to use pre-printed physician order sheets for this study? YES  FORMCHECKBOX  NO  FORMCHECKBOX  Anticipated Start Date: FORMTEXT       End Date  FORMTEXT       Study Duration  FORMTEXT       Signature of PI  FORMTEXT   Date  FORMTEXT       INVESTIGATOR CHECK LIST: (Items to be submitted / addressed with the application)  FORMCHECKBOX  Form 1 (Application for Approval to Conduct Research at The Med)  FORMCHECKBOX  IRB approval of HIPAA waiver has been obtained (if applicable). For chart review activities, investigators must obtain a HIPAA waiver from the IRB and submit such waiver letter as part of the application. HIPAA Authorization or Waiver must be obtained whenever patient charts are to be screened to identify patients who are eligible for inclusion in a study.  FORMCHECKBOX  Investigator Qualifications: A MED-credentialed Principal Investigator must be identified for each research project. If the investigator is a student, non-faculty member, or a faculty member whose expertise is not clinical, or if invasive methods (i.e., blood draws) are a part of the research protocol, a Co-Principal Investigator must be identified who is both a UT faculty member and a physician with privileges at The MED and credentialed to practice in the specialty where the research is to be conducted. Faculty/student investigators will not need to seek credentialing from The MED in order to conduct research at The MED, provided a Co-Principal Investigator is so credentialed.  FORMCHECKBOX  A contract is needed if services are required from The MED. If applicable, a study-specific written contract for clinical research hospital services between the institution (e.g. UT, UTMG, or InMotion Musculoskeletal Institute) and The MED is required. If no services are to be provided by The MED, this should be stated in a cover letter (sample wording: This will confirm our understanding that no services will be performed at The MED which are chargeable to this Study; therefore, there will be no reimbursement to The MED from ________________ for services.). (insert name of Institution)  FORMCHECKBOX  There are research-related services for which The MED will not be reimbursed. Please provide an explanation in the cover letter.  FORMCHECKBOX  If using a Pre-printed Physician Order Sheet, please submit a copy.  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