TMC Research Study Questionnaire

Transcription

1 TMC Research Study Questionnaire For the purpose of this form Tulane Medical Center (TMC) refers to Tulane Hospital, Lakeside Hospital, Tulane Children s Hospital and all of the Tulane Medical Center related clinics that are operated by HCAHealthcare. This form must be completed regardless whether or not your study is funded and if ANY of the following conditions apply to your study: 1) TMC personnel will perform some or all study procedures; 2) the study will use the research pharmacy; 3) the study will involve TMC patients and/or medical records; and 4) Study subjects will be recruited at TMC facilities. Instructions: Step 1: At the time of IRB submission please submit the following hardcopy documents to Manda Martin in Room 2800 (Administration) of the Tulane Medical Center- Downtown Hospital. This form signed by the PI Draft Meditech Charges Form Study Protocol Draft (submitted) Informed Consent/Assent Form(s) (if applicable) Set up a meeting for the following Monday between 9-9:30 a.m. to discuss the study with hospital administration. Step 2: Meet with Dr. Trey Dunbar and Mary Failla to discuss protocol and finalize forms. Meet with Michelle Steinforth to review TUMG charges. Following the meeting, you will receive a signed copies of the Meditech Charges form and this form from hospital administration. Step 3: After receiving IRB approval, send the following documents to Verna Lee (vernalee@tulane.edu) with a cc: to Sande Harmon (sharmon1@tulane.edu) for processing of an account: This form signed by PI and Dr. Dunbar Meditech Charges Form signed by PI, Coordinator, TUMG, and Mary Failla IRB Approval Letter Study Protocol Stamped Informed Consent/Assent Forms(s) (if applicable) HIPAA Form (if applicable) Copy of IRB submission fee IT (if applicable or provide account number in Study Details Section) If your study requires the use of Tulane Electronic Medical Records please submit the appropriate Data Use Agreement(s) or EMR Access forms to Marylin Summerville (marylin.summerville@hcahealthcare.com) and Deena Patcheco (deena.patcheco@hcahealthcare.com). Click here to access the forms.

2 Study Details: Study Title: Sponsor: Principal Investigator: IRB #: Anticipated IRB Meeting date: IRB Approval Date: (if not approved leave blank until submitted to Verna Lee) Primary Research Coordinator: GL Account #: (Account used for submitting IRB submission fee) Study Protocol: Provide a brief summary of the protocol include any information specific to activities involving TMC locations (all clinics, Tulane Downtown Hospital, Lakeside Hospital and Tulane Children s Hospital) or staff. Also include a study flow chart or visit schedule with a list of procedures done at each visit. Please be specific about which component(s) of the study are investigational, due to investigation, or standard of care. Does this study involve an intervention (i.e. drug or device)? Yes No If yes, what is the name of the drug/device/intervention: Please provide the Jcode for the supplying drug:

3 How many subjects are expected to be enrolled locally? What are the anticipated start and stop dates for the study? Start: Stop: Has the study been registered on ClinicalTrials.gov? If yes, provide the NCT#: TMC Specifics: Yes No What research activities will TMC be involved in? (Check all that apply) Research Pharmacy Recruitment (including prescreening and EMR searches) Study Visits Radiology Pathology Procedures Medical Record Review only (if checked skip to Research Team Section) If study visits or procedures are occurring in TMC locations please indicate which locations will be used: TMC Outpatient: Location. TMC Inpatient: Location. Will Medicaid patients be enrolled? Yes No Will TMC staff be involved in any procedures or visits? Yes No If yes, please describe their role in the research: How will the TMC staff be trained on their responsibilities? Who will be responsible for the training of TMC staff? Will any TMC equipment be utilized as part of the study? Yes No

4 If yes, which equipment and how will it be used? Will any medical equipment not belonging to TMC be utilized? Yes No If yes, what equipment and who will be providing the equipment? Who will be using this equipment? Who will be responsible for storage and maintenance? Please provide the make, model, and serial number (if known below) Make: Make. Model: Model. Serial #: Serial #. In accordance with the Joint Commission Environment of Care Standard EC 1.6, all medical equipment entering TMC (this includes satellite clinics), regardless of ownership (physician owned, sponsor owned, loaner, etc) must have an incoming safety inspection and evaluation. Contact TMC BioMed Department at How will TMC be reimbursed for treatment of an adverse reaction? Research Team: Please list the names of all research staff who will be working on this study. Co- or Sub-Investigators: Research Coordinators:

5 Research Assistants: Administrator: Will any research staff be submitting paperwork to gain access to ecw or Meditech? Yes No If yes, please list the names: Names. Name: Billing Contact Information: Mailing Address: PI Signature Date TMC Representative Signature Date