Boston University Medical Center



Clinical and Translational Science Institute

General Clinical Research Unit

APPLICATION FOR USE

|Office Use Only: |

|SPID #_________________ |

|Title of Study: |

|Multicenter: Yes No |

|Phase: I II III IV N/A |

|Principal Investigator (PI) |

|Name: |Degree(s): |

|BU/BMC ID: |eRA Commons User Name: |

|Telephone: |Department: |

|Fax: |Section: |

|E-mail: |Research Area of Interest: |

|Office Address: | |

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|Medical Coverage |Project/Research Coordinator Contact |

|(This must be an MD with BMC Hospital privileges) | |

|Name: |Name: |

|Degree(s): |Telephone: |

|BU/BMC ID: |Fax: |

|eRA Commons User Name: |Email: |

|Telephone: |Office Address: |

|Email: | |

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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: |

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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

1. CLINICAL RESEARCH PROTOCOL

Is this an investigator written protocol? Yes No

2. PUBLIC/PRIVATE FUNDING FOR STUDY

Is this a government-sponsored protocol? Yes No

Is this a foundation-sponsored protocol? Yes No

Funded Research: Yes 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? Yes No

If yes, please indicate the areas of awarded funding:

Outpatient visits or Inpatient days Yes No

Ancillary patient care services (lab, EKG, DEXA, etc.) Yes No

Patient care or ancillary service supplies Yes No

Gov’t/Foundation Name: Date Submitted to Sponsor: Estimated Funding Date:

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3. INDUSTRY

Is this an industry-initiated clinical trial? Yes No

Is this industry-funded but investigator-initiated research? Yes No

(If yes, please supply documentation to support this.)

Company Name: Date Contract Submitted by BUMC to Company:

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NIH CERTIFICATION FOR PROTECTION OF HUMAN SUBJECTS

INVESTIGATOR TRAINING

Some of this information is available at the following website:

|Name(s) |Initial Date of Certification |Date of |Location of Training |

|(All personnel listed on GCRU and IRB | |Re-certification |(BUSM, NIH, or other) |

|applications) | | | |

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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 |

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Co-Investigators (PhDs/MDs)

|Name |Degree(s) |eRA Commons Name* |BU/BMC ID* |

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*Tracking information for CTSI Administration.

APPLICATION

1. 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 (bu.edu/ctsi).

2. Research Subject Diagnosis –

Are subjects normal volunteers? Yes No

If no, please provide diagnosis:

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3. 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:

4. 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

5. 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.

6. Detailed Annual Usage and Costs

Annual Information

|Initial IRB Approval Date: |Month: Day: Year: |

|Expected Completion Date: |Month: Day: Year: |

|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: 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 | | | |

Clinical Lab Tests

|TEST |NO. OF PATIENTS |NO. PER PATIENT |TOTAL |

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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 |NO. OF PATIENTS |NO. PER PATIENT |TOTAL |

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