Download University of Pennsylvania w Institutional Review Board QA/QI

University of Pennsylvania  Institutional Review Board
QA/QI Determination Form
This worksheet is a guide to help the investigators and IRB determine if the quality assurance/quality
improvement activity is human research as defined by the Health and Human Services (HHS) or Food and
Drug Administration (FDA). Instructions appear as italicized blue text. The IRB will contact you with the
results of their review and may request additional information to assist with their determination.
Activities that meet the definition of human research will require submission to the IRB via HS-ERA
(https://medley.isc-seo.upenn.edu/hsProtocol/jsp/fast.do). QA/QI Activities that do not meet the definition of
human research will be reviewed and granted a letter of QA/QI review and acknowledgement from the IRB.
If there is interest in disseminating or publishing the results of the QA/QI activity, this correspondence can
be submitted to a peer-reviewed journal or other publication as evidence of IRB review.
Project Title:
Principal Investigator
Name:
Job Title:
Department:
Ed.D.
Pharm.D.
J.D.
R.N.
Phone:
Cell
phone:
PennCard
ID:
M.D.
Ph.D.
Other (specify):
Fax:
Pager:
Email:
Provide a brief summary of the purpose of the proposed activity (please limit to 1-2 paragraphs)
Describe the proposed procedures and methods (please limit to 1-2 paragraphs)
I. HHS Determination: Human Research
Please check one of the 3 boxes below which best describes your project.
1. A systematic investigation, including research development, testing, and evaluation, designed to
develop or contribute to generalizable knowledge.
2. Quality improvement or quality assurance activity where the results may be generalizable outside of
the institution and publication or dissemination of results may be contemplated.
3. NOT a systematic investigation designed to contribute or develop to generalizable knowledge (e.g.,
medical case reports of 3 or fewer patients, quality improvement or quality assurance activities developed
for a specific clinical area or patient population with no intent to publish or disseminate the results outside of
the institution).
II. FDA Determination: Human Research (Clinical Investigation)
Does the research involve use of any of the following FDA regulated products?
Form Version 11 April 2009
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University of Pennsylvania  Institutional Review Board
QA/QI Determination Form
1.
2.
3.
Drug or Biologic
Medical Device
Dietary Supplement where the supplement is used for diagnosing, mitigating, treating or curing a
specific disease or class of diseases
In this case, the dietary supplement is subject to FDA drug regulations.
None of the above
III. Institutional Operations
Is the goal of this project to advance clinical quality or operational goals for a department/institution? ?,
Yes
No
If yes, please explain and identify the operational leader that is supporting this project?
[Examples of operational leaders include a medical director of a unit or clinical area, division/department chief, nurse
manager, Dean, other health system or institutional leader that can approve the implementation of a quality
assurance/improvement project].
Form Version 11 April 2009
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