EDUCATION & QUALITY IMPROVEMENT PROGRAM
O FFICE O F R ESEARCH
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 Biomedical 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 Biomedical 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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