Where CTCU OCT Checklist

User Manual: CTCU

Open the PDF directly: View PDF PDF.
Page Count: 2

DownloadWhere CTCU OCT Checklist
Open PDF In BrowserView PDF
INITIATING CLINICAL TRIAL CONTRACT REVIEW WITH DGSOM – CLINICAL TRIAL
CONTRACT UNIT (“CTCU”) - USEFUL INFORMATION AND FORMS
What to submit to CTCU:
These documents are the required for your Contract Officer to review & sign a Clinical Trial
Agreement (“CTA”). The department/division is responsible for getting documents to CTCU. The
highlighted documents must be submitted to start the CTCU review process. All documents are
required prior to contract signing. An explanation of these documents follows the list.
1. Goldenrod
2. Protocol
3. Clinical Trial Agreement
4. Financial Disclosure form - Statement of Economic Interests for Principal Investigators – “Form
700U” and Industry Clinical Trials Supplement if necessary
5. Financial Disclosure form - Investigators' Statement of Financial Interests – “Form 700U
Addendum” for persons other than the PI who are responsible for the design, conduct or reporting of
the trial, and Industry Clinical Trial Supplement if necessary
6. Informed consent
7. IRB approval
8. Budget
9. Principal Investigator Exception Letter when necessary
10. For Department of Medicine Investigators, please also submit the DOM “Other Support Form”
& “Top Ten Investigator Responsibilities” Form
The minimum documents should be forwarded to your Contract Analyst.

CTCU Checklist revised 1-2011

Explanations:
1. Goldenrod http://www.research.ucla.edu/ocga/forms/goldrod2.pdf
The Goldenrod is UCLA’s internal submission and approval form. The form contains a summary of important trial information. Once
the form is completed it is circulated to: the PI, his/her Chair or Dean, his/her MSO, the Medical Center Director for their review and
approval to move forward. CTCU will accept a draft signed by the PI in order to get started in reviewing the CTA.

2. Protocol – The official current protocol should be provided.
3. Clinical Trial Agreement – The written understanding between the university and the funding source and/or drug or device
provider. There are many companies with whom UCLA may already have master agreement. Contact your Contract Analyst or Officer
to find out if a master agreement or template exists. If you have the electronic version it should be forwarded directly to your assigned
Contract Analyst. You Contract Officer can also assist in drafting an agreement if the sponsor does not have a standard agreement.

4. Statement of Economic Interests for Principal Investigators – “Form 700” and Industry Clinical Trials
Supplement if necessary
The original Form 700U must be sent to CTCU. California law requires this disclosure and an original complete form signed by
the Principal Investigator must be provided whenever new funds are being provided. An academic peer committee reviews disclosures.
For more information about the committee go to: http://www.research.ucla.edu/researchpol/coi.htm
To obtain the Form 700U go to: http://www.research.ucla.edu/researchpol/forms/Form700U.pdf
To complete the Industry Clinical Trials Supplement smart form online go to:

http://www.research.ucla.edu/researchpol/CT_Disclosure_Supplement/profile.asp
NOTE – If contracting through a Contract Research Organization (CRO) then forms are required for both the CRO and the underlying
sponsor of the study.

5. Investigators' Statement of Financial Interests – “Form 700U Addendum” for persons other than the PI who are
responsible for the design, conduct or reporting of the trial, and Industry Clinical Trials Supplement if necessary.
The original Form 700U Addendum must be sent to CTCU. Remember the PI must also sign this form in addition to the other
investigators on the study. An academic peer committee reviews disclosures. For more information about the committee go to:

http://www.research.ucla.edu/researchpol/coi.htm
To obtain the forms go to: http://www.research.ucla.edu/researchpol/forms/700-U_Addendum_Dec2007.pdf
To obtain the supplement go to: http://www.research.ucla.edu/researchpol/CT_Disclosure_Supplement/profile.asp

NOTE – If contracting through a Contract Research Organization (CRO) then forms are required for both the CRO and the underlying
sponsor of the study.
6. Informed consent
7. IRB approval- the university policy requires that the Institutional Review Board approval be in place prior to execution of the
Clinical Trial Agreement. For more information about the IRB go to: http://ohrpp.research.ucla.edu/
8. Budget - for contract review purposes a draft may be provided but the final approved budget must be provided to your Contract
Officer before the Clinical Trial Agreement may be signed.
9. Principal Investigator Exception letter – If the PI is not eligible to serve as a PI pursuant to UCLA policy APPM 900 (go to
http://www.adminvc.ucla.edu/appm/_entry_900.html) then it is necessary to have their Chair or Dean approve them as a principal
investigator on each trial. Generally investigators with an academic title code of 1, 2, or 3 are eligible all others require a letter of
approval.

10. DOM Other Support form – the Department of Medicine requires that principal investigators track their percent of effort on
research projects. This form must be completed prior to the clinical trial receiving its fund number.
REMEMBER: 1 through 5, are the minimum documents required to open a proposal file and begin the contracting
process at CTCU.

CTCU Checklist revised 1-2011
Source Exif Data: 
File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.5
Linearized                      : Yes
Author                          : Helene Orescan
Comments                        : 
Company                         : UCLA
Create Date                     : 2011:01:31 15:49:48-08:00
Modify Date                     : 2011:01:31 15:49:54-08:00
Source Modified                 : D:20110131234858
Subject                         : 
Tagged PDF                      : Yes
XMP Toolkit                     : Adobe XMP Core 4.2.1-c043 52.372728, 2009/01/18-15:08:04
Metadata Date                   : 2011:01:31 15:49:54-08:00
Creator Tool                    : Acrobat PDFMaker 9.1 for Word
Document ID                     : uuid:d9660434-e7c8-474e-9e5a-b941e9c5fc51
Instance ID                     : uuid:b61bcf02-0f60-4727-8c34-f05082e2fe07
Format                          : application/pdf
Title                           : Where:  For the Faculty/Staff section of the website
Description                     : 
Creator                         : Helene Orescan
Producer                        : Adobe PDF Library 9.0
Keywords                        : 
Page Layout                     : OneColumn
Page Count                      : 2
EXIF Metadata provided by EXIF.tools

Navigation menu