HUMAN GENE TRANSFER PRIMARY REVIEW
SUBMISSION PACKAGE
To the clinical research study manager:
This package will help you to prepare your Human Gene Transfer protocol BUA C_________
for review by the UCSD Institutional Biosafety Committee (IBC). WCG Biosafety is working
with UCSD IBC to review your protocol.
In order to initiate the review process, please complete the following steps.
Step 1: Email the completed Primary Review Form (PRF, next page below) to
dkavanagh@wcgclinical.com. For assistance with the PRF, please contact Project
Manager Daniel Kavanagh.
Daniel G. Kavanagh, PhD
Senior Director of Biosafety and Gene Therapy
WCG Biosafety
Phone: (781) 223-8631
dkavanagh@wcgclinical.com
Step 2: Upload the following documents to the UCSD BUA Submission system:
Proposed Protocol (version to be reviewed)
Investigator’s Brochure
Proposed Consent Form(s) for the clinical site (draft acceptable)
All relevant correspondence to and from the RAC (Recombinant DNA Advisory
Committee, NIH), including Appendix M responses, exemptions, etc.
Any other relevant documentation to assist with review.
Version 14 Jan 2016 DGK
PRIMARY REVIEW FORM- Human Gene Transfer Submission
SF1.
PROTOCOL INFORMATION
UCSD BUA
#C
Principal Investigator
First line of Study Title
Sponsor Protocol #
OBA/RAC Protocol #
Do you have a specific calendar requirement for opening enrollment?
*If yes, date:
SF2.
Yes*
No
explain:
CLINICAL RESEARCH STUDY MANAGER INFORMATION
The Clinical Research Study Manager is the person designated as the primary contact for WCG Biosafety during Human Gene
Transfer Review services.
Clinical Research Study Manager:
Title:
Phone:
SF3.
Email:
ADDITIONAL CONTACT INFORMATION
Sponsor:
Name:
Address:
City:
State:
Zip code:
State:
Zip code:
Country:
Contact Name:
Phone:
Email:
CRO (agent for the sponsor): if applicable
Company Name:
Address:
City:
Country:
Contact Name:
Phone:
Email:
SF4. BILLING INFORMATION FOR PROTOCOL REVIEW
NOTE: The Human Gene Transfer Submission constitutes a request from UCSD for WCG Biosafety to provide primary
review of the research protocol. WCG Biosafety will bill third parties (e.g., Sponsor or CRO) directly only when we are
authorized to do so; otherwise, payment responsibility remains with UCSD.
Party to be billed*:
Address:
Mail Stop/Cost Center:
City:
State:
Zip code:
Country:
Phone:
FAX:
Email:
“ATTENTION”:
Describe any special billing instructions: (I.e. purchase order number or reference number)
SF5.
PERSON COMPLETING THIS FORM
Name/Title Person Completing Form
Phone
Date
Version 14 Jan 2016 DGK