Date Received:
Protocol №:
Administrator:
Institutional Review Board (IRB)
Office of Regulatory Research Compliance LCSB 28
(Phone) 442-9050 (Fax) 442-9997 (E-mail) irb@albany.edu
Institutional Review Board (IRB)
POST-APPROVAL MONITORING SELF-ASSESSMENT
The completed form may be submitted either by hard copy or via e-mail
The Guide for the PAM self-assessment form is available at http://www.IRB@albany.edu.
Principal Investigator Information
Investigator Name:
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Title:
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Co-Investigator Name: Click here to enter text.
Protocol Number:
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Protocol title:
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E-mail address:
Click here to enter text. @albany.edu
E-mail address:
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APPROVAL AND RECORD KEEPING
YES NO
NA
COMMENTS
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Required training/documentation is available for all key study
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personnel.
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The principal investigator is aware of the protocol expiration ☐
date.
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Appropriate study records are retained and available.
RESEARCH PROTOCOL
YES NO
NA
COMMENTS
Only IRB-approved procedures and processes been followed.
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Only IRB-approve modifications to protocol were implemented.
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Only IRB-Approved data collection tools and study instruments
have been used.
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All unanticipated problems or adverse events, complaints, or
subject withdrawals have been reported to the IRB.
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RECRUITMENT
YES NO
NA
COMMENTS
Recruitment was done by the method described in approved
protocol.
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Only IRB-approved advertising, flyers, or recruitment materials
have been used to recruit subjects for the study.
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INFORMED CONSENT PROCESS
Only IRB-approved informed consent information has been
used to enroll subjects.
YES NO
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NA
COMMENTS
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Informed consent process has been uniform and in
accordance with IRB-approved process.
RESEARCH PROTOCOL
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YES NO
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NA
COMMENTS
Study records are secured and safeguards are in place to
protect confidentiality as approved by the IRB.
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Study codes are used appropriately (data are de-identified)
and study codes and identifiable data stored separately.
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Hard copies of forms and/or electronic data are stored in a
secure, locked, and protected location.
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QUALITY IMPROVEMENT
YES NO
COMMENTS
Do you have any questions or concerns about your protocol?
If yes, please describe the items in the space provided.
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Overall, I am satisfied with the IRB review process.
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Overall, I am satisfied with ORRC customer service.
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Do you have any suggestions, recommendations or
observations with regard to the protocol review process? If
yes, please describe.
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CONTINUING EDUCATION AND TRAINING
YES NO
COMMENTS
Are there IRB-related topics for which you would like
information or guidance?
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Would you like to request a training session for your class or
department? If Yes, an ORRC staff member will follow up
with you.
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INVESTIGATOR ASSURANCE
By checking the box below, the investigator assures that the responses in this form are accurate and
acknowledges responsibility to adhere to the above-referenced IRB-approved protocol.
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Name of Investigator : Click here to enter text.
Date: Click here to enter a date.
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