Clinical and Translational Science Institute General Clinical Research Unit APPLICATION FOR USE

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

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)

BU/BMC ID: eRA Commons User Name:

E-mail: Research Area of Interest:

Office Address:

Medical Coverage

(This must be an MD with BMC Hospital privileges)

Project/Research Coordinator Contact

eRA Commons User Name: Email:

Telephone: Office Address:

Email:

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

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:

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:

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)

(All personnel listed on GCRU and

IRB applications)

Initial Date of Certification

Date of Re-certification

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

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 (www.bu.edu/ctsi)

2. Research Subject Diagnosis –

Are subjects normal volunteers? Yes No

If no, please provide diagnosis:

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

PATIENTS

NUMBER PER PATIENT

TOTAL DEXA Bone Density

DEXA Fat Distribution

Analysis

Treadmill

EKG

Polysomnography

Video Taping Lab

Indirect Calorimetry

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 NO OF PATIENTS NO PER PATIENT TOTAL