Welcome CTRC Investigators!
Please read all instructions and complete the application process in order to use resources at the CTRC Westwood site. Both the UCLA CTRC Scientific Advisory Committee and the Operations Committee will review your submitted application and documents in order to determine allocations for resource use. It is very important that your application is COMPLETE for these review processes to occur or there will be delays in approval. The CTRC review process may be initiated in parallel with the IRB approval process.
If you would like to receive assistance with setting up your study from the beginning (i.e. IRB submission, IND, budgeting, coverage analysis, contracting, study registration, etc.) please contact the Clinical Study Activation Team at the Clinical Trials Administrative Office whose members are available to assist.
If you are only requesting to use REDCap, please contact Martin Lai, Informatics Manager, for further instructions.
The following items are requested at the time of submission:
PLEASE NOTE: Items 1-6 are required
1. CTRC Application *
2. CTRC Protocol Financial Information Form *
3. Final Study Budget (NEW requirement)
4. Web-IRB application in .pdf format
5. IRB-approved consent form if available, otherwise a draft should be provided
6. Study protocol
7. Investigator’s Brochure (if applicable)
8. For ISPRC-reviewed protocols, please attach a copy of the ISPRC approval letter
*Forms are available at the CTRC website on the CTSI virtual home: http://ctsi.ucla.edu/ctrc/ucla/pages/
The above materials should be submitted electronically to:
Helen Williams-Bayne Phone: 310-267-1029
If you have questions about specific topics on the application, please contact the following responsible individuals PRIOR to submitting your application. If you would like a tour of the facilities or have questions about other UCLA Clinical and Translational Science Institute (CTSI) Resources or using our partner resources (Cedars-Sinai, L.A. Biomedical Research Institute, or Charles Drew University), please contact:
Helen Williams-Bayne Phone: 310-267-1029
Application/Funding Helen Williams-Bayne, M.B.A.
In-Patient/Out-Patient Nursing e-mail: Phone: 310-267-1029
Mobile Nursing
Study Coordinator Services
For lab testing pricing information, please visit: http://finance.mednet.ucla.edu/cdmweb/clinicaltrial/default.htm
or contact UCLA Centralized Research Billing Partners (CRBP) at
Pre-study Regulatory Support Maggie Lindenbaum
and Study Coordination e-mail: Phone: 310-794-3788
Regulatory/Quality Assurance Terra Hughes
and Data and Safety Monitoring e-mail: Phone: 310-794-8900
Training in Clinical Research
Informatics Core/REDCap Martin Lai, M.S.
e-mail: Phone: 310-794-9396
Nutrition and Metabolic Support Patricia Jardack, M.S., R.D.N.
Services e-mail: Phone: 310-825-5768
CareConnect Access “Anna” Chen Zheng Phone: 310-267-1033
CTRC Scheduling e-mail:
*********************************************************************************************************************************************************
A. PROTOCOL INFORMATION
PROTOCOL NUMBER To be assigned by CTRC
TITLE Please use the exact same protocol title on this application as the one on the webIRB application.
TYPE OF STUDY (please check only one box)
NIH or other federal sponsor, single site study
NIH or other federal sponsor, multi-center study, UCLA as lead site
NIH or other federal sponsor, multi-center study, UCLA is not lead site
Industry-sponsored study, investigator-initiated
Industry-sponsored study, single site (not investigator-initiated)
Industry-sponsored study, multi-center
Multi-center study, UCLA is lead site (not NIH or industry-sponsored)
Multi-center study, UCLA is not lead site (not NIH or industry-sponsored)
Foundation
Departmental
Other, please describe ______
SPECIFIC CTRC INTEREST AREAS (please check all that apply)
Clinical Trial
HIV/AIDS Related
Pediatrics
Rare Disease
Pilot Study
SPECIAL POPULATIONS (please check all that apply)
Age:
Children 0-10.99
Adolescents 11.0-17.99
Young adults 18-26.99
Elderly 65+
Race-Ethnicity Category (likely 2020 Census categorization)—other than “White”:
Hispanic, Latino or Spanish
Black or African-American
Asian
American Indian or Alaskan Native
Middle Eastern or North African
Native Hawaiian or other Pacific Islander
Some other race, ethnicity or origin
Primary Language other than English Spoken at Home:
Yes
No
Particularly Vulnerable Population:
Formerly incarcerated
Child protective services-involved, foster care or child welfare
LGBT
Homeless
Uninsured
Undocumented
Immigrants
Adults with intellectual disabilities
AIDS/HIV
Others Need to be Identified:
______
------
PRINCIPAL INVESTIGATOR and CO-INVESTIGATORS LISTING (PLEASE READ CAREFULLY)
Please provide information for all investigators conducting this study. The name of the Principal Investigator listed on this application must match the Principal Investigator on the web-IRB application and all the study-related documents as this person is responsible for the overall conduct of the study. At least one physician (MD) must be listed on this application, named in the consent, and have admitting privileges to the Medical Center. This individual is responsible for the physician’s orders, their accuracy, and implementation. Any exceptions to these rules must be reviewed by the Unit Director and the CTRC Operations Committee.
All personnel working on the CTRC are required to be certified in research, which includes the following Collaborative Institutional Training Initiative (CITI) modules - Human Subjects Protections, Good Clinical Practice, and UCLA HIPAA-Research. The recommended module, FDA-Regulated Research, is for those study teams conducting drug/device/biologic studies. The CITI program may be accessed at https://www.citiprogram.org/
Name Title
Affiliation/Department Pager or Cell Phone
Phone Fax e-mail
PI Financial Officer Financial Officer Phone
Grant or Sponsor Name Grant Number
Account & Fund Number Recharge ID
Funding Start Date Funding End Date
PI eRA Commons Username:
Research Certifications: Certificate Date
Human Subjects Protections ______
UCLA HIPAA-Clinical Research ______
Good Clinical Practice ______
FDA-Regulated Research ______
______
Name Title
Affiliation/Department Pager or Cell Phone
Phone Fax e-mail
Research Certifications: Certificate Date
Human Subjects Protections ______
UCLA HIPAA-Clinical Research ______
Good Clinical Practice ______
FDA-Regulated Research ______
STUDY COORDINATORS LISTING Please provide information for all study coordinators working on this study.
Name Title
Affiliation/Department Pager or Cell Phone
Phone Fax e-mail
Research Certifications: Certificate Date
Human Subjects Protections ______
UCLA HIPAA-Clinical Research ______
Good Clinical Practice ______
FDA-Regulated Research ______
______
Name Title
Affiliation/Department Pager or Cell Phone
Phone Fax e-mail
Research Certifications: Certificate Date
Human Subjects Protections ______
UCLA HIPAA-Clinical Research ______
Good Clinical Practice ______
FDA-Regulated Research ______
No Study Coordinator
REGULATORY COORDINATOR LISTING Please provide information for the designated regulatory coordinator working on this study.
Name Title
Affiliation/Department
Phone Fax e-mail
Research Certifications: Certificate Date
Human Subjects Protections ______
UCLA HIPAA-Clinical Research ______
Good Clinical Practice ______
FDA-Regulated Research ______
No Regulatory Coordinator
B. SPECIFIC AIMS (Please state the primary aims of the study)
C. ABSTRACT/SUMMARY (Briefly)
D. BIOSTATISTICS Please provide a statistical analysis plan and a sample size calculation in your protocol submission documents and indicate the name of the biostatistician with whom you are working below. If this is a pilot study, please state so and the rationale for the number of subjects. For assistance with biostatistical planning and analysis, including database development, please contact Dr. David Elashoff at: or Sarmen Hakopian at
Name Title
Affiliation/Department
Phone e-mail
E. DATA AND SAFETY MONITORING
Has the Data and Safety Monitoring Plan (DSMP) been approved by an NIH Institute or undergone another peer review process?
Yes
No
*Please include all relevant information about the DSMP and the DSMB (if applicable) in one of the following: the web-IRB application, this application, or as an attachment.
F. QUALITY ASSURANCE
Who will conduct protocol compliance checks and data accuracy reviews?
Name: ______Affiliation: ______
Title: ______Phone: ______
Need Assistance
G. CLINICAL STUDY REGISTRATION
Has this study been registered at either clinicaltrials.gov or other national study registry?
Yes, name of registry ______Registration Number ______
In progress
H. NUMBER OF RESEARCH SUBJECTS
1. What is the anticipated accrual at UCLA for this study and over what period of time?
______(subjects)/______(period of time)
2. If this is a multi-center study, what is the anticipated accrual nationwide/worldwide and over what period of time?
______(subjects)/______(period of time)
I. CTRC USAGE REQUEST
a. Anticipated Start Date of the Study: ______
b. Anticipated Completion Date of the Study: ______
c. Patient age range: _____
d. Inpatient total number: _____
Number of admissions per patient: _____
Length of admission (days): _____
e. Outpatient total number: _____
Number of visits per patient: _____
Length of visit (hours): _____
J. CTRC RESOURCES REQUESTED (PLEASE BE AS SPECIFIC AS POSSIBLE)
1. Nursing Care and Mobile Nursing
Yes (provide details and specific in-patient and out-patient needs for CTRC nursing staff, including whether routine clinical care will be provided as part of the protocol and whether you have needs for Mobile Nursing within the UCLA Health System)
______
No
2. Study Coordinator Services
Yes (provide details of proposed percentage time, types of duties – study start-up, regulatory, subject recruitment, study implementation, subject visits, data management, etc)
______
No
Laboratory Support:
Yes (provide details and specific needs for specimen processing and aliquoting, including any weekend visits; All clinical and research laboratory testing is conducted by the Center for Pathology Research Services (CPRS). Contact information for CPRS is on the front page of this application.
______
No
3. Nutrition and Metabolic Support Services:
Yes - research meals (specify if protocol defined diet, regular meals without dietary restrictions, test meals, or other dietary needs), nutrition or dietary assessment, anthropometry, exercise or resting metabolic testing, research nutritionist/dietitian consultation, and other nutrition needs
______
No
4. Informatics Core/REDCap
Yes (provide details on database management, special applications and/or analysis, including access to REDCap)
______
No
5. Regulatory / Ethics / Quality Assurance / Data and Safety Monitoring / Research Subject Advocacy:
Yes (provide details on what types of services are being requested, which may include consultations on ethics and advocacy, development of processes and plans, review of research forms, quality assurance, or resolving participant concerns/issues.
______
No
6. IRB Submission Assistance / Clinical Trial-Study Registration / IND Assistance
Yes (provide details on what types of services are being requested)
______
No
7. Other Services and Assistance (please describe all other services requested.)
CTSI Research Associates Program (CTSI-RAP) assistance. If you are interested in having undergraduate students from our program assist in the conduct of the study, please indicate such interest here). The CTSI-RAP program is designed to build a stronger support infrastructure for the research initiatives of UCLA faculty physicians and investigators. RAP students play a key role in the implementation and integrity of research protocols in which they are involved (http://ctsi.ucla.edu/education/pages/pipe).
Other
______
As the Principal Investigator, 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 information on the CTRC website and will conduct the study under the guidelines for Good Clinical Practice. All personnel working on this study will ensure that their research training requirements are kept current on the institutional training site (CITI Training). When requested by the CTRC, I will provide status reports for this study. I will also report any changes to the protocol including its temporary or final closure, adverse events/unanticipated problems, and data and safety monitoring information to the CTRC, IRB, campus offices, and state/federal agencies as required. I know that I may contact the CTRC staff at any time to assist with satisfying the above requirements to ensure the safety and welfare of research participants and overall study integrity.
THANK YOU
Version 13.0
09-16
Page 7 of 7