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:
Medical Coverage
(This must be an MD with BMC Hospital privileges) / Project/Research Coordinator Contact
Name: / Name:
Degree(s): / Telephone:
BU/BMC ID: / Fax:
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.

Signature of Principal Investigator: / Date:

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 SPH 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*

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 (www.bu.edu/ctsi).

2.  Data Management-(Data collection forms, Database design and Statistical programming.)

Please contact Christine Chaisson, MPH, Director, Data Coordinating Center at 617-638-5009 or for consultation on checklist.

3.  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 if you are in need of additional assistance.

4.  Detailed Annual Usage and Costs

Initial IRB Approval Date: / Month: Day: Year:
Expected Completion Date: / Month: Day: Year:
Total number of patients expected to be enrolled at 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.

BUSM BMC GSDM SPH Inpatient Outpatient

Number of Patients: / Days per Patient: / Total Days:

Specialized Equipment/Services

TEST / NUMBER OF PATIENTS / NUMBER PER PATIENT / TOTAL
DEXA: Bone Density or
Fat Distribution Analysis
EKG
Video Taping Lab
One-Way Observation Rooms

Clinical Lab Tests

No. of TEST / NO. OF PATIENTS / NO. PER PATIENT / TOTAL

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Date Revised: 5/31/2017