Welcome CTRC Investigators!
Please submit this CTRC application at the same time you submit your application to the IRB. The CTRC Scientific Advisory Committee requests that the following items be submitted with this completed application form:
1. CTRC application
2. Ancillary Services Request Form (for NIH and other non-profit studies only)
3. IRB application (HS-1)
4. Financial form for the study
5. IRB - Approved consent in PDF format.
6. Full study protocol
7. Investigator’s Brochure (if applicable)
8. For Oncology Protocols only, a copy of the ISPRC approval letter
If you have questions, please contact the following person in charge PRIOR to submitting your application.
Funding: Helen Williams-Bayne, M.B.A.
Email: Phone: 310-267-1029
Nursing Care: Regina Olivas, BSN, MSW.
Email: Phone: 310-267-1030
Informatics Core: Martin Lai, M.S.
Email: Phone: 310-794-9396
Bionutrition: Patricia Jardack, M.S., R.D.
Email: Phone: 310-825-5768
Laboratory: Najib Aziz
Email: Phone: 310-267-1037
Please return completed forms by e-mail to NO hardcopy supplements are allowed.
PROTOCOL NUMBER leave blank
TITLE Please use the exact same title of the protocol on this application as the one on the IRB application.
PRINCIPAL INVESTIGATOR and CO-INVESTIGATORS LISTING Please provide information for all investigators conducting this study. If this is an inpatient study, there must be a physician (MD) named in the consent that has admitting privileges to the Medical Center and the physician must sign the physician’s orders for both inpatient and outpatient visits.
Name Title
Affiliation/Department Beeper
Phone Fax e-mail
PI eRA Commons Username
Name Title
Affiliation/Department Beeper
Phone Fax e-mail
STUDY COORDINATORS LISTING Please provide information for all study coordinators working on this study.
Name Title
Affiliation/Department Beeper
Phone Fax e-mail
Name Title
Affiliation/Department Beeper
Phone Fax e-mail
REGULATORY COORDINATOR LISTING Please provide information for the designated regulatory coordinator working on this study.
Name Title
Affiliation/Department Beeper
Phone Fax e-mail
A. SPECIFIC AIMS
B. BACKGROUND AND SIGNIFICANCE (Briefly)
C. BIOSTATISTICAL DESIGN Provide the name of the UCLA biostatistician
Or for assistance with biostatistical design contact the Office of Investigator Services
310-794-CTSI (2874)
1. What is the anticipated accrual at UCLA for this study?
______(participants)/______(period of time)
2. If this is a multi-center study, what is the anticipated accrual nationwide/worldwide?
______(participants)/______(period of time) Not applicable
1. Who will conduct protocol compliance checks and data accuracy reviews?
Name: ______Title: ______
Phone: ______
2. Has the Data and Safety Monitoring Plan (DSMP) been approved by an NIH Institute?
Yes
No
3. Is there an external Data and Safety Monitoring Board (DSMB) that will be monitoring the study?
Yes
No
Please attach listing of members and the Data and Safety Monitoring Plan
4. If there is no external board, please list the internal DSMB Members (if applicable).
If the investigator is the sole Data and Safety Monitor for a minimal risk study, please note that.
Name Title
Affiliation/Department Beeper
Phone Fax e-mail Cell
Name Title
Affiliation/Department Beeper
Phone Fax e-mail Cell
Do any of the above individuals noted above have a conflict of interest that needs to be disclosed?
D. JUSTIFICATION AND NEED FOR CTRC USE
a. Start Date of the Study:
b. Completion of the study:
c. Patient age range:
d. Inpatient number:
e. Number of Admissions per patient:
f. Number of days per Admission:
g. Outpatient number:
h. Number of visits per patient:
i. Length of visits:
Funding Source:
a. Grant Number Start Date:
b. Grant End Date:
c. Name of the Sponsor and Grant Number:
(NIH, a foundation or non-profit, a company or a Corporation)
Study Category:
NIH, non-profit or Investigator Initiated,
Research and routine care
Industry or pharmaceutical company-sponsored
1. Nursing Care: (provide details and specific needs for CTRC nursing staff)
2. Laboratory Support: (provide details for support needed)
3. Bionutrition: (special diet needs, diet restrictions, body measurements, analysis, or menu preparation)
4. Informatics Core: (database management, special applications and/or analysis support from CTRC or access to RedCap)
Yes
No
If yes, please indicate what is needed. ______
By submitting this application to the CTRC, I attest that the above information is true and correct to the best of my knowledge. I have read the CTRC DSM guidelines and will conduct the protocol under the guidelines for Good Clinical Practice. I will report any changes to the protocol, adverse events, and DSM information as required to the CTRC, ORPA, the IRB and other agencies as appropriate.
THANK YOU
Version 5.0
01-23-12
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