INTERNAL
ALBERT EINSTEIN COLLEGE OF MEDICINE and MONTEFIORE MEDICAL CENTER
Internal Adverse Event Policy
Adverse Events must be reported to the designated IRB (AECOM CCI or MMC IRB) within the guidelines stipulated by regulatory and sponsoring agencies and institutional policy. For investigator initiated research the Principal Investigator must submit documentation to the designated IRB that the Adverse Event Report was sent to the FDA and all collaborating institution(s), when AECOM, MMC or the NBHN is the lead institution.
At a minimum, the following guidelines apply for the reporting of Adverse Events:
DEATH:
The following must be reported:
- deaths that occur while subject is on study treatment, or
- deaths that occur within thirty (30) days of conclusion of study intervention
All deaths, whether or not anticipated or related to the protocol, must be reported to the designated IRB within 48 hours of the PI’s knowledge of the death.
Within 10 business days of informing the designated IRB, the Principal Investigator is required to submit a completed Adverse Event Report to the designated IRB.
SERIOUS EVENT:
A serious event is defined as (a) an adverse event, whether or not anticipated, that has the potential to cause significant impairment of health or death; or (b) an adverse event that prompts the Principal Investigator to suspend the research protocol, (temporarily or permanently) even if the risk is explicitly identified in the Consent Form; or (c) events that occur with a frequency or degree of severity greater than anticipated. (Examples of Serious Events are: disability, inpatient hospitalization, prolongation of hospitalization, congenital anomaly, laboratory anomalies critical to safety evaluations, and serious adverse drug reactions.) The following must be reported:
- serious events that occur while subject is on study treatment, or
- serious events that occur within thirty (30) days of conclusion of study intervention
All reportable serious events must be reported to the designated IRB within 48 hours by phone, e-mail, or fax. Within 10 business days of initial notification to the designated IRB, the Principal Investigator is required to submit a completed Adverse Event Report.
Contact Information For Deaths and Serious Events:AECOM CCI: / MMC IRB:
Fax: / 718-430-8817 / Fax: / 718-547-2626
Email: / / Email: /
Phone: / 718-430-2237 / Phone: / 718-798-0406
NON-SERIOUS UNANTICIPATED EVENT:
A reportable non-serious unanticipated event is an adverse event that is not explicitly identified in the consent form and/or in the investigator's brochure, does not pose a serious impairment to a subject's health, and is not life-threatening.
Non-Serious Unanticipated Events must be reported to the designated IRB within 30 days via submission of a completed Adverse Event Report.
EXEMPTIONS
AECOM and MMC policy does not require the reporting of the above Adverse Events for chart review protocols. All other adverse events must be reported as required under this policy unless an exemption is granted. The Principal Investigator is required to submit a written request for Adverse Event reporting exemptions to the designated IRB (AECOM CCI or MMC IRB). Adverse Event exemption requests require review and approval at a convened meeting.
ALBERT EINSTEIN COLLEGE OF MEDICINE
Committee on Clinical Investigations
and
MONTEFIORE MEDICAL CENTER
Institutional Review Board
REPORT OF AN INTERNAL ADVERSE EVENT AND/OR DEATH FOR
RESEARCH STUDY SUBJECTS
The institutions’ assurances with the Department of Health and Human Services for protection of human subjects stipulate that investigators report ALL adverse events in compliance with institutional and regulatory requirements. The requirements for the reporting of adverse events are delineated in the Adverse Event Policy that is appended to this document.
PROVIDE THE FOLLOWING INFORMATION:
SUBMIT THE ORIGINAL AND 3 COPIES OF THIS FORM
IRB Protocol #:Sub. Med. Record #: / GCRC MR#, if applicable:
Title of Protocol:
P.I. Name: / Phone: / E-mail:
Treating Physician:
1. Category of Event: / Death / Serious Event / Unanticipated Event
2. Name of Drug/Device/Intervention/Agent:
3. Relationship of the Adverse Event to the Protocol Treatment Intervention: Check One:
Definite / Probable / Possible / Unlikely / None / Unknown
4. Provide a clinical summary that provides sufficient detail to support your response to item # 3. Include the
location of the patient at the time of the A/E, the temporal relationship between the research intervention and
occurrence of the event, a clinical description of the event, and any other relevant information.
5. Date of most recent protocol treatment: / Date of Event:
Date PI was Informed of Event: / Date of This Report:
6. Institution/Location of Subject at the time of the Event:
7. Protocol Subject Initials: / Age: / Sex:
8. Underlying Health Status of Patient at Start of Enrollment in the Protocol (check one)
Very Seriously Ill (death is likely to occur in the course of the study)
Seriously Ill (death may occur but is unlikely in the course of the study)
Moderately to mildly ill
Generally Healthy
Healthy Control
9. Subject Diagnoses:
Primary:
Other:
10. Period during which Subject was enrolled in this Protocol: / From: / To:
11. At the time of the Adverse Event, was the subject enrolled in another protocol? / Yes / No
If YES, list: / CCI #: / MMC #:
CCI #: / MMC #:
CCI #: / MMC #:
12. What therapy was provided to the subject related to the Adverse Event (as opposed to the underlying condition)?
13. What was the clinical outcome of the therapy provided for management of the Adverse Event?
14. # of Internal Subjects Enrolled on the Protocol Since Initiation:
15. # of Internal Subjects Active on Study Protocol:
16. # of Internal Subjects NOT Active but currently being followed:
17. # of Internal Adverse Events
Since Protocol Initiation: / Deaths / Serious
Events / Unanticipated
Events
18. Does this protocol involve the use of Recombinant DNA? / Yes / No
19. If this Adverse Event is a Death, check as appropriate:
Subject was participating in the research protocol at the time of death
Subject was off protocol less than six (6) months, but contact with the subject had been maintained.
Cause of Death:
20. If Applicable, Date of Adverse Event Report to Protocol Sponsor:
When new information regarding risks or benefits becomes known during the study, re-evaluation of the study is required. This new information must be added to the informed consent document. Visit http://www.aecom.yu.edu/home/CCI/new_risk_policy.htm to view the CCI Policy on New Risk Information.
21. In your opinion, does this adverse event affect the risks or benefits to research participants? / Yes / No
If YES, submit with this report the revised the informed consent document(s), including:
a) The approved consent form(s) currently in use
b) The proposed revised consent form(s) with the proposed revisions highlighted
c) A clean version of the proposed revised consent form(s) and, if applicable, a "New Information Letter".
If YES, research participants followed under this protocol must also be provided with the new information. Under certain circumstances, those who have previously participated in the study may need to be informed of the new information.
Indicate below all procedures that will be used for informing active participants and, if applicable, those who have completed the study.
· Active participants will be asked to sign the revised informed consent document. / Yes / No
· Active participants will be mailed a letter containing the new information and reiterating the right to withdraw from the study without any loss of benefits. / Yes / No
· The new information will be discussed with active participants at the next study visit. / Yes / No
· Previously enrolled participants will be informed of the new information by (check one):
letter
telephone
other means of communication (specify) / Yes / No
A NOTE MUST BE PLACED IN THE RESEARCH RECORD CONCERNING THE PROCEDURES THAT HAVE BEEN USED TO NOTIFY PARTICIPANTS.
22. RECRUITMENT STATUS
Recruitment is open
Recruitment is permanently closed
Recruitment is on hold by (check below, as applicable):
PI
Sponsor
Other (specify)
23. STATUS OF THE STUDY
The study is ongoing
The study is terminated
Provide any additional information that you believe will enhance the review and understanding of this adverse event.
REMINDERS:
- A COPY OF THE ADVERSE EVENT REPORT THAT WAS SUBMITTED TO THE PROTOCOL SPONSOR, AND/OR THE FDA, MUST BE APPENDED TO THIS FORM.
- ONE (1) COPY OF THE MOST RECENTLY APPROVED INFORMD CONSENT MUST BE INCLUDED WITH THIS SUBMISSION (FOR ON-GOING STUDIES ONLY).
If other than the Principal Investigator, the name of the individual who completed this form:Name: / Phone #: / E-mail:
Signature of Investigator: / Date
SEND REPORTS TO MMC IRB AND/OR AECOM CCI AS FOLLOWS:
Studies approved by the AECOM CCI - send to CCI (1002 Belfer) {Original Only}
Studies approved by the MMC IRB - send to MMC Research Administration Office (3308 Rochambeau Ave) {Original and three (3) copies. As well as one (1) copy of the most recently approved informed consent (for on-going studies only)}
Studies approved by the MMC IRB that involve JMC/NCB - send simultaneously to BOTH offices as per the instructions outlined above.
In addition, for Oncology Studies Monitored by the Cancer Center Protocol Review and Monitoring Committee, forward an additional copy to Oncology, Weiler 2 South, (Phone: 718-904-2730).
Form Revised: 5/13/08 Page 1 of 5 F:\IRB Information\IRB New forms\Internal AE Report.doc