GCRC Use Only

University of California, Davis

/ #______
General Clinical Research Center /

______

Application to Use the GCRC
Project Title: ______
PI: / DEPT: / PHONE:
CI: / DEPT: / PHONE:
CI: / DEPT: / PHONE:
CI: / DEPT: / PHONE:

Date of Application Submission: ______

PI Campus Mailing Address:______

______

Administrative Contact Person (AA, Research Coordinator): / Phone:
Pager:
Clinical Contact Person (Nurse, Research Coordinator): / Phone:
Pager:

Dates of proposed project: to

Dates of proposed GCRC use: to

GCRC Submission Checklist:

Information needed to review your study protocol:

Completed Application to Use the GCRC

Original Grant, Contract, DOS, and Investigators Brochure

Copy of IRB Review Application Form (please note if approved or pending)

Human Subjects Consent Form (please note if approved or pending)

Before the protocol can be approved, all of the investigators must certify that they have received education on the protection of human research participants.
All investigators have attended the IRB/HIPAA workshop or have completed the web-based training and their names appear on the IRB list of investigators
Prior to IRB and GCRC approval, the investigator(s) listed above will complete Human Subjects
Training either by attending a local IRB session or by completing the Web Site course and forwarding
the certificate to the GCRC.

A Data and Safety Monitoring Plan (DSMP) has been developed for this protocol.

PI or Physician Who Will Be Responsible for Medical Care of Subjects
IRB #

Print Name

Approval Date:

Research Proposal

Anticipated Use of GCRC

total # of subjects / # inpatient days/subject / Total inpatient days
# outpatient days/subject / Total outpatient visits

Project Funding Information

Is your protocol supported by external funding? Yes No

Source(s) and amount of external funding. (note pending applications)

Is the protocol supported by industry? Yes No

Does this study include any “Standard of Care” treatment, tests or procedures? Yes No

If the protocol is supported by industry, who initiated it? Investigator Industry

If investigator initiated, documentation of this must be provided.

Abstract

(Please insert a clear, concise summary of your study here, aiming for 200 words)

Request to Use GCRC Services

Which services will you need?

Inpatient Unit

Outpatient Unit

Scatter Bed

Nutritional Assessment and Services

Imaging- Radiology

X-ray (body region to be imaged: )

CT (body region to be imaged: )

MRI (body region to be imaged: )

Ultrasound (body region to be imaged: )

PET (body region to be imaged: )

Body Composition Laboratory

DEXA ( Bone Density, Total Body Fat)

Bod Pod

PQCT

Analytical Laboratory

Blood / tissue sample processing

DNA sample processing

Routine chemistry/hematology

HPLC, GCMS, Flow Cytometry

Biostatistics

Informatics

Database assistance

Videotaping

File transfers

Please clearly explain how the GCRC services requested above will be utilized for your protocol.

GCRC – Targeted/Planned Enrollment Table

Human Subjects

Risk to the Subjects (Human Subjects Involvement, Sources of Research Material, Potential Risks);

Adequacy of Protection Against Risks (Recruitment and Consent Procedures, Protection Against Risk);

Potential Benefit of the Proposed Research to the Subjects and Others;

Importance of the Knowledge to be Gained;

Inclusion of Children, Inclusion of Minorities, Inclusion of Women;

Targeted/Planned Enrollment Table:

Overall recruitment goals for this proposal will be:

TARGETED/PLANNED ENROLLMENT: Number of subjects
Ethnic category / Sex/gender
Females / Males / Total
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category Total of All Subjects
Racial categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
Racial Categories: Total of All Subjects

GCRC Safety Monitoring Plan

Project Title:
GCRC Protocol #______ / Study Coordinator:
Principal Investigator:

SAFETY MONITORING PLAN

(if your grant includes the current NIH DSMP information listed below, insert your text here)

Safety Assessment Risk:

Description of Anticipated Adverse Events and Their Expected Frequency:

Description Of Safety Monitoring:

Description of How AEs Are Graded:

Plan for AE Reporting:

Performance and Frequency of Safety Reviews:

List names of the individual(s) who will perform the safety monitoring: (The safety monitor may be the principal investigator, an independent internal reviewer, an external reviewer or a data safety monitoring board.)

To report serious or unexpected adverse events you must complete an IRB Adverse Event Form within 15 days of the event. Copies must be sent to the IRB, GCRC and to any other agencies or centers involved in your study.
Questions about safety monitoring plans may be directed to Research Subject Advocates Sara Schmidt, PharmD, at or Theodore Wun, MD, at

Submit electronic copies of the following documents (with your name in the title) via e-mail to Jessica Hicks at / Contact Phone: 916-843-9178 / Fax: 916-843-9437

Information needed to review your study protocol:

Completed Application to Use the GCRC
Original Grant, Contract, DOS, and Investigators Brochure
Copy of IRB Review Application Form (please note if approved or pending)
Human Subjects Consent Form (please note if approved or pending)

Other

UC Davis offers Volunteer Student Services for Investigators. Undergraduate and Graduate level students are available to provide assistance to you while gaining a valuable learning experience in research. Send brief job description, supervisor name, and contact number to: Johanna Medellin, Supervisor Volunteer Services,

Phone: 916-734-8938 / Fax: 734-0800

Duties can include:

Inputting data

Collecting data

Interviewing patients/subjects

Lab setting type duties

Paperwork

Computer Work

Documentation

Research

Would you be interested in this resource?

Yes No

Also, please briefly describe what qualifications you might require. Include, for example, an estimate of how many hours per week, length of commitment (1 or 2 quarters, etc.).