HRP-542 Internal Report

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Internal Report
Document No.:
Date:
HRP-542
07 Feb 2016
Page:
Page 1 of 2
<Name of Organizational Official>
<Address of Organizational Official>
<Phone Number of Organizational Official>
<Email Address of Organizational Official>
Dear <Hailing of Organizational Official>
We submit this report to fulfill regulatory requirement to follow written procedures to ensure
prompt reporting appropriate institutional officials of (i) any unanticipated problems involving
risks to subjects or others or any serious or continuing noncompliance with the regulations or the
requirements or determinations of the IRB; and (ii) any suspension or termination of IRB
approval.
This is a report of: <delete all that do not apply>



An unanticipated problem involving risks to subjects or others
Serious or continuing noncompliance with the regulations or the requirements or
determinations of the IRB
A suspension or termination of IRB approval
The study information is as follows:
Type of review:
Title:
Principal investigator:
IRB number:
IND or IND number, if any:
HHS grant title and ID, if any:
Documents reviewed:
On <Review Date> the IRB reviewed the following:

<Insert description of what the IRB reviewed>
Description of the Problem

<Insert description including the findings of the organization and the reasons for the
IRB’s decision>
Actions the Organization is Taking or Plans to Take

<Describe actions>
Internal Report
Document No.:
Date:
HRP-542
07 Feb 2016
Page:
Page 2 of 2
Follow-up Plans

<Describe plans, if any, to send a follow-up or final report by the earlier of (1) a specific
date or (2) when an investigation has been completed or a corrective action plan has
been implemented>.
Please let us know if you need additional information.
Sincerely,
IRB Office
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