Please Call (207) 396-8242 If You Need Assistance Completing This Form

Please call (207) 396-8242 if you need assistance completing this form.

Definitions:

A major protocoldeviation / violation is an event that may impact subject safety;make a substantial alteration to risks to subjects. Examples of major violations may include, but are not limited to:

• Failure to obtain informed consent, i.e., there is no documentation of informed consent, or informed consent is obtained after initiation of study procedures;
• Enrollment of a subject who did not meet all inclusion/exclusion criteria;
• Performing study procedure not approved by the IRB;
• Failure to report serious unanticipated problems/adverse events involving risks to subjects to the IRB and (if applicable), the sponsor;
• Failure to perform a required lab test that, in the opinion of the PI, may affect subject safety or data integrity;
• Drug/study medication dispensing or dosing error;
• Study visit conducted outside of required timeframe that, in the opinion of the PI or IRB, may affect subject safety;

Unanticipated Problem:

Report to MMC IRB unanticipated problems which in the opinion of the investigator have already or may in the future adversely affect the rights, safety, or welfare of the subjects or which significantly impact the integrity of research data. Examples of unanticipated problems that may affect the rights, safety or welfare of the subjects:

• Loss of laptop that contains subject/patient PHI or loss of video tapes containing sensitive information.
• A hurricane or building malfunction in which all of your patient/subject data has been destroyed and there is no back-up. In a case such as this, the PI may have to concede that the integrity of the study has been compromised resulting in an early closure of your study.

A planned protocol exceptionis any prospective request for an intentional deviation from the IRB approved protocol that involves a to participants or others, except when necessary to eliminate an apparent immediate hazard to a participant.

If you are participating in a sponsored study you will need to contact the sponsor and request a protocol exception and submit the sponsor’s approval documentation with the attached form.

Principal Investigator Name: Today’s Date:

MMC IRB Number:

Study Drug/Device:

Subject ID:

Date of Occurrence:

1. Describe in detail the MAJORprotocol deviation / violation OR unanticipated problem that occurred OR reason for the planned protocol exception :

• If more room is necessary, please attach a second page. Please attach any documentation from the study sponsor that supports this request.

Please send complete form and attachments to the Research Compliance Office at 81 Research Drive, ScarboroughMaine 04074 (interoffice mail or fax (207) 396-8141)

Page 1 of 2 SOP #RR 404-E Effective Date: 08/23/2011 Supercedes Date: 06/20/2011