EXTERNAL ADVERSE EVENT REPORTING FLOWCHART



Mount Carmel Institutional Review Board

Office of Research Affairs/IRB Office

Mount Carmel Corporate Services Center

6150 East Broad Street

Columbus, OH 43213

Phone: 614-546-4325 | Fax: 614-546-4328

Email: irb@

INTERNAL ADVERSE EVENT REPORTING FLOWCHART

Federal regulations at 21CFR 56.108(b)(1) require the IRB to “follow written procedures for ensuring prompt reporting to the IRB…of…Any unanticipated problems involving risks to human subjects or others…”

Investigators are required to report adverse events that fit the following criteria:

← The event is unanticipated (an event is unanticipated when the nature, severity or frequency is not identified in the investigator brochure or described in the protocol. Events which are already cited in the investigator brochure or protocol are not unanticipated and do not have to be reported to the IRB).

AND

← Event is possibly related to the study design, procedures, or drug/device. If the adverse event is clearly not related to the study drug, device, procedures it would not represent a risk to others in the research, therefore, does not have to be reported to the IRB.

Is the internal event unanticipated? No

( Do Not Submit

( Yes

Is the internal event possibly related

to the drug, device or procedure? No

( Yes ( Do Not Submit

Submit to IRB for review.

(

Does the protocol or informed consent

document for the Mount Carmel study No

require modification or does the study need ( Do not submit an amendment

to be placed on hold or suspended?

( Yes

Submit modified protocol/consent document

to the IRB

Exceptions:

• An adverse event that is related, expected or is not serious, but in the opinion of the investigator the protocol or consent document requires modification. Example: identification of a “new trend” or change in the risk/benefit ratio.

• All deaths regardless of relationship to the protocol must be reported according to Mount Carmel IRB policy.

• All device related adverse events must be reported according to Mount Carmel IRB policy.

• The Investigator has the option of reporting any adverse event which, in his/her opinion, the IRB should review regardless of the criteria above.

Mount Carmel Institutional Review Board

Office of Research Affairs/IRB Office

Mount Carmel Corporate Services Center

6150 East Broad Street

Columbus, OH 43213

Phone: 614-546-4325 | Fax: 614-546-4328

Email: irb@

Internal Adverse Event

Reporting Form

Internal adverse events are those adverse events experienced by subjects enrolled in research relying on the Mount Carmel IRB for review. Investigators must report any adverse event that is unexpected and related (or possibly related) to participation in research. For more information refer to the Adverse Event Reporting policy.

Complete a separate form for each event.

Example: If a patient is hospitalized and subsequently dies, the incidents are reportable as two separate events. The first event is the hospitalization and follow-up event #1 is the death.

|Administrative Information |

|IRB Assigned Protocol Number |      |

|(required): | |

|Study Title: |      |

| | |

| | |

| | |

|Sponsor Protocol Number: |      |Version Date: |      |

|Research Site(s): |

| Mount Carmel West Mount Carmel East Mount Carmel St. Ann’s |

|Mount Carmel New Albany Surgical Hospital Fairfield Medical Center Physician’s Office |

|Other, specify:      |

|Principal Investigator: |

|Name: |      |

|Address: |      |

| | |

|Telephone: |      |Fax: |      |E-mail: |      |

|Primary Contact / Coordinator [if other than PI]: |

|Name: |      |

|Address: |      |

| | |

|Telephone: |      |Fax: |      |E-mail: |      |

|Study Information |

|Study Status: | Open Closed to enrollment Terminated |

|Subject Initials or Study |      |

|Number: | |

|Subject Age: |      |

|Subject Sex: | Male Female |

|Follow-up report: | No |

| |Yes |

| |( If Yes, Follow-up Report Number 1 2 3 4 |

|MedWatch / IND Report #: |      |

|Event was: | Expected Unexpected |

| |Note: An adverse event is considered unexpected if it is not consistent with: |

| |the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in |

| |the protocol-related documents, such as the IRB-approved research protocol, any |

| |applicable investigator brochure, and the current IRB-approved informed consent |

| |document, and |

| |(b) other relevant sources of information, such as product labeling and package inserts; or |

| |(2) the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and |

| |the subject’s predisposing risk factor profile for the adverse event. |

|Type of Event: |Note: The adverse event is serious if the event meets any of the following criteria: |

| | |

| |Congenital Anomaly Death Death-due to disease progression |

| |Hospitalization Life threatening Multiple Events |

| |New Cancer Other “Serious” Persistent Disability |

| |Prolonged Stay Protocol Error Severe/Permanent Disability |

| |Significant Overdose |

|Study Related: | Definitely Related Probably Related Possibly Related Unlikely Related Unrelated |

| |Unknown |

| |The adverse event is related if it is at least partially caused by the procedures involved in the research. |

|Date of Event: |      |

|Patient Status: | Patient continued treatment/intervention Patient discontinued |

| |Patient off study (completed treatment prior to the event) Patient treatment on hold |

| |Patient off treatment and in follow-up Patient died |

| |Unknown Treatment interrupted |

| |Dose adjustment/alteration Undetermined at this time |

| |Temporarily discontinued study treatment/intervention No action taken |

| |Permanently discontinued treatment/intervention |

|Description of event (attach |      |

|additional page if needed): | |

| | |

| | |

| | |

| | |

| | |

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| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

| | |

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| | |

|Reported event addressed in the protocol and consent | N/A |

|document: |Yes |

| |No |

|Reported event addressed in the Investigator Brochure | N/A |

| |Yes |

| |No |

|Are changes required to the Protocol? | Yes |

| |No |

|Are changes required to the Consent document? | Yes |

| |No |

|If changes are required to the protocol and/or consent document, complete an Amendment Form and attach a copy of the revised protocol and/or informed consent with changes |

|highlighted. |

|Individual reporting the event: |      |

|Date: |      |

|Signature: | |

|Principal Investigator: |      |

|Principal Investigator Signature: | |

|If the principal investigator is not the individual reporting | |

|the event, indicate the date when the investigator became |      |

|aware of the event: | |

-----------------------

For Office Use Only

Date Received:

Internal #

Type of Review: [ ] Full Board [ ] Expedited

Determination:

[ ] Continue as submitted

[ ] Additional information required

[ ] Changes recommended to protocol and/or

informed consent document

[ ] Place on hold. Discuss with PI.

[ ] Report to Institutional Official

Date:

Chairperson Date

Mount Carmel Institutional Review Board

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