IRB Protocol #:
Principal Investigator:
Study Title:
2. Subject Information
Reference #: / Patient Name: / Medical Record #
Phase of Study: / Patient Age: / Patient Gender:
Date of Event: / Time of Event: / Date P.I. Aware:
Initial Report Follow-up Follow-Up#
3. Description of Event (provide a brief description of the events (e.g., neutropenia, rash, hypotension) and when it occurred in relationship to drug administration, use/implantation of device, study procedures, etc.)
4. Agent/Device Information
Name of Agent/Device:
If Agent, fill-in the following information:
Total daily dose given: / Route of administration:
Grade of Toxicity: / Toxicity Criteria Used:
Multi-Drug Regimens:
Dates of Administration: From: To:
5. Investigator’s Assessment of Relationship to any Part of Protocol Treatment
Related - / Probably Related -
Not Related - / Probably Not Related -
Undetermined - / Possibly Related -
6. Investigator’s Assessment of Severity of the Event
Mild - / Life-threatening -
Moderate - / Fatal -
Serious -
7. Outcome
Alive without sequelae / Still under treatment for:
Alive with sequelae / Died Date:
8. Summary Information
Was the event carcinogenic? / Yes / No
Was the event an overdose? / Yes / No
Was the event a congenital anomaly? / Yes / No
Was the event expected or unexpected? / Expected / Unexpected
Other / Expected / Unexpected
9. Treatment Status
Was the treatment stopped? / Yes / No
If yes, was it resumed? / Yes / No
Was the treatment altered? / Yes / No
If yes, explain:
10. Treatment of Event
Was hospitalization required to treat the event? / Yes No
Briefly describe treatment given:
11. Concomitant Medications and Medical Diagnoses
Please list Medication, Treatment dates, The purpose of treatment, Dose, Route.
You may include an extra sheet for multiple medications/treatments.
12. Frequency of Event
(For unexpected or life-threatening or fatal events which are possibly, probably or directly related to the study drug/device/procedures, provide information on number of subjects enrolled study-wide and number of subjects experiencing this side effect study-wide. This information should be obtained from the sponsor).
# of events: # enrolled: as of (date):
13. Protocol/Consent Form Changes
The risk of this side effect/event is included in the currently approved protocol/consent form.
This risk/event was felt to be unrelated or unlikely to be related to the study drug/device/procedures and does not have to be added to the protocol/consent form.
The protocol has been revised to eliminate or minimize this risk. A revised protocol is attached.
The consent form has been revised to include the risk of this side effect/event. A revised consent form is attached.
14. (Attach a copy of the notification for each of the following in the box below)
If an IND agent or an IDE: date sponsor or FDA notified in writing:
If marketed agent date MedWatch/Medical Device Report form was sent to the sponsor or FDA:
P.I. Signature Date
The principal investigator must sign this form, as the individual responsible for the conduct of the study.
Enter this AE on the Adverse Event Log which is required to be submitted annually at the time of Continuing Review.
FOR IRB USE ONLY:Does this report require a referral to Quality Management? Yes No
Date referred to Quality Management: ______
Patient Name: ______
Medical Record #______
and/or
Account #______
Date of Service: ______
serious and/or unexpected adverse event report
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