Adverse Event Report

Adverse Event Report

Institutional Review Board

for the Protection of Human Subjects in Research

New Mexico Tech's Institutional Review Board (IRB) is charged with protecting the rights and welfare of human research participants recruited to participate in research activities conducted at New Mexico Tech.

Thank you for bringing this to our attention.

This form should be used to report single adverse events. A separate Incident Report (i.e., reports of problems involving the conduct of the study or human participants, including problems with the recruitment and/or consent processes, and/or any deviations from the approved protocol) in letter format, addressed to the IRB Administrator, should attached to this form.

IMPORTANT: Once the IRB Adverse Event Report Form is complete request a copy be sent to your NMT email for your records. Forward that email to the IRB Admin at irb@nmt.edu

Researcher Name*

Department*

Primary Phone #*

Phone

Primary NMT Email*

Title of Project/Research*

Original Period of Project / Research

IRB Database Number:*

Numbers only

IRB Approval Date:*

IRB Expiration Date:*

Adverse Event Details

Please attach your incident report statement to this document as well in the file upload located at the bottom of this form.

Adverse Event (3-4 words)*

Date of Event*

Adverse Event Appears to Be*

Directly related to the research

Indirectly related to the research

NOT related to the research

Additional Details or Summary of Adverse Event

A detailed report should also be attached

Questions

Please answer the following questions to the best of your ability

Question 1*

Was use of procedure intended to directly benefit the subject?

Yes

Question 2*

Has this type of adverse event been reported before?

Yes

Question 3*

Is this type of event likely to occur again?

Yes

Question 4*

Is the event adequately described in the protocol and consent form?

Yes

If Yes:*

If you answer YES here, please complete a modification application found here: https://app.smartsheet.com/b/form/04c48171164a454e856a8f1d50762158

If No*

If NO, are changes needed in the protocol and/or consent form?

Yes

Question 5*

Have other agencies or sponsors been notified of this adverse event?

Yes

Please list those agencies or sponsors*

Principal Investigator/Researcher Assurance*

As principal investigator/researcher, I hereby assure that the information I have provided on this form is correct and accurate, to the best of my knowledge.

Is a Faculty Advisor Assurance Required?*

Yes

Faculty Advisor Assurance*

I understand a signed assurance statement from my faculty advisor is required, including their name, signature, and date, as soon as possible to aid in Adverse Event Report review. It should be attached with this form but can be sent afterwards directly to irb@nmt.edu.

File Upload*

Please attach a full Incident Report describing the Adverse Event for the IRB to this form. Attach any other necessary documents here as well.

~Thank you

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