Promptly Reportable Information
Submission Form
For priority processing submit this completed Form via Connexus®
Forms submitted to [email protected] will be processed as they are received.
1. Identifying Information:
Protocol Number:
PI Name:
Date of this Report:
Date of this Event:
Date Reported to Sponsor
(if applicable):
Submitting Body:
Date of Occurrence:
Subject ID (If applicable)
Is the subject still enrolled
in the study?
IRB Tracking Number:
PI
Sponsor
CRO
SMO
Other
Yes
No
If no, state reason
2. Type of problem: Information not listed below does not require reporting to CGIRB.
Audit, inspection, or inquiry by a federal agency
Written report from a federal agency (e.g., FDA Form 483) Submit a complete copy of all reports
and correspondence related to the inspection. (e.g. FDA Form 482 and 483, Site’s Response to the
483, FDA letter responding to the site, EIR Summary, FDA WARNING Letter, Health Canada
Inspection Notice, Health Canada Exit Notice)
State medical board action Submit a copy of state medical board licensing documentation (e.g. a
physician’s (suspended) license, a physician profile, or a physician licensing profile indicating a
disciplinary, or even a non-disciplinary action)
Allegation of Noncompliance or Finding of Noncompliance Submit documents related to the
event.
Suspension or premature termination by the sponsor, investigator, or institution Submit a copy of
correspondence related to the suspension or premature termination and provide additional
explanation if applicable.
Incarceration of a subject in a research study not approved to involve prisoners If a subject
becomes incarcerated at any time during a study, provide details including the date of
occurrence or discovery, time line and actions taken.
New or increased risk If the new or increased risk(s) is changing the protocol and/or consent
form, please submit as a change in research. If the new or increased risk(s) will change the
protocol and/or consent form in the future, please provide as much detail about the possible
change and the expected timeline for that change. If the new or increased risk(s) is not changing
the protocol and/or consent form at this time, please provide the reason why in box #4.
CGI-244 E001
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Promptly Reportable Information Submission Form (continued)
Adverse events or IND safety reports that require a change to the protocol or consent If the event
is changing the protocol and/or consent form, please submit as a change in research. If the new
or increased risk(s) will change the protocol and/or consent form in the future, please provide as
much detail about the possible change and the expected timeline for that change. If the event is
not changing the protocol and/or consent form at this time, please provide the reason why in box
#4.
Unanticipated adverse device effect
Protocol deviation that harmed a subject or placed subject at risk of harm
In Box 3, explain any harm the subject experienced OR how the subject was placed at risk of
harm
In Box 4, explain the corrective action taken for this event AND your plans to avoid future
occurrences
Protocol deviation made without prior IRB approval to eliminate an immediate hazard to a subject
In Box 3, describe the situation and why immediate action was required. State if sponsor was
notified (attach any correspondence)
In Box 4, explain your plans to avoid future occurrences, if applicable
Breach of confidentiality
Unresolved subject complaint
Other information the sponsor/CRO has directed the PI to report to the IRB, even if not on this list
and does not meet any of the reporting requirements (above).
If you have an event you considered reporting and determined it was not reportable, you may mark
the box below, print the form and keep it in your records (do not send to CGIRB):
This information does not need to reported to CGIRB. Comments:
3. Describe the problem (e.g., date of occurrence or discovery, time line, cause, actions taken,
changes made):
4. What actions need to be taken, or what changes are proposed to protect research subjects or others
(e.g., corrective and preventive actions). If none, justify.
5. The submission of this form means that the Principal Investigator is agreeing to and is responsible
for the accuracy of all information being provided to CGIRB.
Person completing form:
Name:
Title:
E-mail:
Phone: (
)
CGI-244
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