Clinical and Translational Science Institute General Clinical Research Unit APPLICATION FOR USE Office Use Only: SPID # _ TITLE OF STUDY: Multicenter: Yes Phase: I II No III IV N/A Principal Investigator (PI) Degree(s): eRA Commons User Name: Department: Section: Research Area of Interest: Name: BU/BMC ID: Telephone: Fax: E-mail: Office Address: Medical Coverage Project/Research Coordinator Contact (This must be an MD with BMC Hospital privileges) Name: Degree(s): BU/BMC ID: eRA Commons User Name: Telephone: Email: Name: Telephone: Fax: Email: Office Address: CERTIFICATION OF ACCEPTANCE I hereby certify that the statements, herein, are true and complete to the best of my knowledge and accept the obligation to comply with PHS, BMC, BUSM, and GCRU policies and procedures Signature of Principal Investigator: Date Revised: November 2009 Date: of APPROVALS Food and Drug Administration: Pending IND # N/A Certificate of Confidentiality: Yes Pending N/A BUMC IRB Approval: Yes Pending IRB No.: WIRB Approval: Yes Pending WIRB No.: FUNDING CLINICAL RESEARCH PROTOCOL Is this an investigator written protocol? Yes PUBLIC/PRIVATE FUNDING FOR STUDY Is this a government-sponsored protocol? Is this a foundation-sponsored protocol? Funded Research: Yes Yes Yes No No No No Pending Grantee Institution BUSM BMC Name of Funding Organization/Sponsor: Principal Investigator (local): Sponsor Grant Number: Annual Direct Funds for project: Annual Indirect Funds for project: Total Period of Funding (mm/dd/yy): to If this is a subcontract, please specify grantee PI Were any funds awarded to cover patient care or lab expenses? If yes, please indicate the areas of awarded funding: Outpatient visits or Inpatient days Ancillary patient care services (lab, EKG, DEXA, etc.) Patient care or ancillary service supplies Gov’t/Foundation Name: Date Submitted to Sponsor: INDUSTRY Is this an industry-initiated clinical trial? Is this industry-funded but investigator-initiated research? (If yes, please supply documentation to support this.) Company Name: Company: Date Revised: July 2009 Yes No Yes Yes Yes No No No Estimated Funding Date: Yes Yes No No Date Contract Submitted by BUMC to of NIH CERTIFICATION FOR PROTECTION OF HUMAN SUBJECTS INVESTIGATOR TRAINING Some of this information is available at the following website: https://dcc2.bumc.bu.edu/ocr/nihcertification.aspx Name(s) Initial Date of Date of (All personnel listed on GCRU and Certification Re-certification IRB applications) Location of Training (BUSM, NIH, or other) CREDENTIALED PERSONNEL The individuals below on your staff for this study are credentialed and/or have privileges at Boston Medical Center to perform the duties, procedures, or tests required on this study This will include MDs and non-MDs such as nurses, therapists, etc Name Degree(s) Position Procedure/Test CO-INVESTIGATORS (PhDs/MDs) Name Degree(s) eRA Commons Name* BU/BMC ID* *Tracking information for CTSI Administration Date Revised: July 2009 of APPLICATION Need for Resources – Briefly state why you feel that the medical and/or dental GCRU is necessary and appropriate for your study, and which facilities and resources you will be using See the Resources section of the GCRU website (www.bu.edu/ctsi) Research Subject Diagnosis – Are subjects normal volunteers? Yes If no, please provide diagnosis: No Bionutrition Services – Those subjects who are fasting and/or at the GCRU for two hours or longer qualify for meal service Meals needed? Yes No Special instructions: Data Management– Yes No If yes, please specify below and/or contact Christine Chaisson, MPH, Director, Data Coordinating Center at 617-638-5009 or chaisson@bu.edu for consultation on checklist Checklist for data management services: Data Collection Forms Database Design Statistical Programming Statistical Methodology and Data Analysis – All protocols must have a statistical section reviewed for experimental design, sample size calculation, and data analysis Section G (Sample Size/Data Analysis) in your IRB Application will be used to support this request for use of the GCRU The GCRU has statistical methodology and data analysis services Contact Howard Cabral, PhD, MPH at 617-638-5024 or hjcab@bu.edu if you are in need of additional assistance Date Revised: July 2009 of 6 Detailed Annual Usage and Costs Annual Information Initial IRB Approval Date: Expected Completion Date: Number of subjects in Year One: Total number of patients expected to be enrolled at BMC/GSDM over entire study: Estimated date of entry of first patient: Month: Month: Day: Day: Year: Year: Month: Day: Year Estimated Annual Usage Patient Care Units Please list number of patients on an annual basis Inpatients at Boston Medical Center Number of Patients: Days per Patient: Total Days: Outpatients at Boston Medical Center Number of Patients: Visits per Patient: Total Visits: Length of Visit: Outpatients at Dental Unit Goldman School of Dental Medicine (GSDM) Number of Patients: Visits per Patient: Total Visits: Length of Visit: Specialized Equipment/Services Special Equipment and/or Services requested: Yes No If yes, indicate the special procedures that you require at the Medical GCRU TEST NUMBER OF PATIENTS NUMBER PER PATIENT TOTAL DEXA Bone Density DEXA Fat Distribution Analysis Treadmill EKG Polysomnography Video Taping Lab Indirect Calorimetry One-Way Observation Rooms Date Revised: July 2009 of Clinical Lab Tests TEST NO OF PATIENTS NO PER PATIENT TOTAL CORE Lab Tests (Medical Unit) Indicate what CORE laboratory tests you require Call Dr Tai Chen at 617-638-4543 for information on CORE lab capabilities Email is: taichen@bu.edu TEST Date Revised: July 2009 NO OF PATIENTS NO PER PATIENT TOTAL of ... information for CTSI Administration Date Revised: July 2009 of APPLICATION Need for Resources – Briefly state why you feel that the medical and/ or dental GCRU is necessary and appropriate for. .. section reviewed for experimental design, sample size calculation, and data analysis Section G (Sample Size/Data Analysis) in your IRB Application will be used to support this request for use of the... who are fasting and/ or at the GCRU for two hours or longer qualify for meal service Meals needed? Yes No Special instructions: Data Management– Yes No If yes, please specify below and/ or contact