EDUCATION & QUALITY IMPROVEMENT PROGRAM
OFFICE OF RESEARCH
5171 California Blvd., Suite 150
Irvine, CA 92697-7600
Phone: (949) 824-4768
Fax: (949) 824-1465
http://www.research.uci.edu/compliance/human-research-protections/index.html
EQUIP Review Prep & Timeline for Social Behavioral Research
Pre-Meeting Responsibilities:
1. Forward the following documents to the EQUIP team in advance of the review session:
a. A copy of the Lead Researcher’s Curriculum Vitae
b. List of publications or citations – highlight those related to the current study
c. Copies of actual publications or citations related to the current study
2. Review the document titled, “EQUIP Expectations for Social Behavioral Researchers” as part of
preparing for the EQUIP review.
3. Kindly ensure that there will be a work space for the EQUIP staff to review study documents on
the date of the review. Please ensure that there is also enough room for you, your study team
and the IRB Chair for the introduction and exit portion of the review (as applicable).
4. Please make sure that all applicable study documents, binders and files are available for review.
Documents may be maintained in hard copy or electronically. IRB Documentation for each
research study should be maintained in chronological order. For hard copy files, the most
current, IRB–approved documents should be placed on top. Electronic records should be also
be maintained in a clear and organized manner.
The following is an outline of the audit review process for your reference.
This process will take place over the course of one day and may involve several hours.
1. Initial Review Meeting with Lead Researcher, Study Staff (as applicable) and
EQUIP Team (time: 30 minutes):
a. EQUIP Team will outline goals of review process. Study Team is encouraged to ask
questions throughout.
b. EQUIP Team will ask Study Team specific questions regarding subject recruitment, study
procedures and processes. Study Team is again encouraged to ask questions
throughout. It is recommended that those key Study Team members most involved in
the research itself be available.
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2. Audit / Review Process (time: dependent on documentation):
a. EQUIP Team will ask one member of Study Team to be available / on call for the
duration of the review (this individual does not have to remain in room with EQUIP
Team – this is just in case there are any questions during the review process). Study
Team member can be available by phone or pager.
b. EQUIP Team will review materials as provided by Study Team.
c. EQUIP Team provide summary of findings to the IRB Chair.
3. Exit Portion (time: 30 minutes):
a. EQUIP Team, along with IRB Chair will present review preliminary findings to the Study
Team. Lead Researcher must be present during this portion of the visit, along with
applicable members of the Study Team. Study Team is encouraged to ask questions
throughout.
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4. Final Documentation (10 business days post review):
a. EQUIP Team will forward final audit/ review report to the Lead Researcher via email
within 10 business days post the review visit. Based on the findings, a response by the
Lead Researcher may or may not be required.
b. Additional educational materials may be provided to Lead Researcher and Study Staff,
as needed or requested.
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