Download QUALITY ASSURANCE / IMPROVEMENT PROGRAM

QUALITY ASSURANCE / IMPROVEMENT PROGRAM
1. OBJECTIVES
a) Outline procedures and responsibilities for the Quality Assurance/Improvement
(QA/QI) program at the Atlanta VA
b) The QA/QI Program identifies and corrects deficiencies on an ongoing basis
c) Provide ongoing training and education to research staff in ethical principles and
proper research conduct
2. RESPONSIBILITIES
a) The Principal Investigator is responsible for ensuring that research studies are
conducted in compliance with federal regulations and institutional policies
b) Ensures the quality and integrity of data when conducting human research
studies
c) Ensures regulatory compliance with VA policies and procedures
d) Ensures that all study staff adheres to the study protocol for quality and
consistency
e) Makes study files accessible to the Research Compliance Officer (RCO) for
review when conducting QA assessments or assessing non-compliance issues
3. PROCEDURES
a) Investigator and study staff should self–assess their study performance prior to
QA Assessment visit
b) QA forms are available at: www.atlaref.org for research & drug/device studies
c) The Research Compliance Officer (RCO) will schedule visits randomly or on an
as needed basis to assess study performance
d) The PI and Research Coordinator will be notified of the QA visit in advance in
order to prepare properly
e) QA Assessment visit duration may vary depending on findings or the study
complexity
f)
Makes study files accessible to the Research Compliance Officer (RCO) for
review when conducting QA assessments or assessing non-compliance issues
g) All study documents must be available to the RCO to review upon scheduled
visit. Items reviewed will include the Regulatory Study Binder and the following
documents:
I. Approved Protocol
II. Original and revised Informed Consent Forms (if any)
III. IRB Submission and R&D Committee Forms
IV. IRB and R&D Committee approval letters
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V.
VI.
VII.
VIII.
IX.
X.
XI.
XII.
Enrollment log
Modifications (amendments)
SAE Reports
Continuing Review (renewals)
Case Report Forms/ Data Collection Forms
Source Documents
Study staff log and training records
Documentation verification of the informed consent
discussion and research encounters
XIII. Sponsor Correspondence (if applicable)
h) After initial review, the RCO will meet with the study coordinator (and PI if
necessary) to discuss discrepancies, findings, and to make study performance
improvement recommendations
i)
The QA assessment form information is verified with the Emory IRB and R&D
databases to confirm accuracy and ensure consistency of information
j)
If the study involves drugs, the Research Pharmacist will complete the
Investigational Drug section and notify the RCO of any discrepancies
k) Once the assessment is completed, a written summary will be sent to the PI
and Research Coordinator
l)
The PI or designee will be responsible for clarifying any pending issues and for
replacing any missing documents in the study binder
m) If a non-compliance issue is discovered during the visit, the RCO generates a
written report for the Non-Compliance Review Committee (NCRC)
n) The NCRC will convene a meeting face to face or via teleconference to discuss
the issue
o) The NCRC sends a written report to the IRB with the recommended course of
action. Some of the findings requiring action are:
I.
II.
III.
IV.
V.
VI.
VII.
Missing documents
Discrepancies in study information
Altered documents
Poor Data collection or falsification
Failure to follow protocol-required instructions
Protocol violations
Use of an unapproved Informed Consent Form or lack of subject
signature or altered consent forms
VIII. Failure to obtain written consent prior to initiating study activities
IX. Failure to report Serious and Unexpected Adverse Events
p) The IRB will assess the NCRC report and other evidence and determine whether
the non-compliance is serious or ongoing
q) The IRB will issue a report with its findings
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r) The PI is required to send a written response no later than 30 days after the
date of the letter. The response time may be shorter depending on the nature of
non-compliance.
s) The Chief Research Service, IRB Chair, and the R&D Committee Chair will also
receive copies of the correspondence.
t)
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Reporting to the Office of Research Oversight (ORO), Office of Human Research
Protection (OHRP), Food and Drug Administration (FDA), and/or the Atlanta VA
Quality Management Department, respectively may be required.