Office for Human Research Studies
DANA-FARBER / HARVARD CANCER CENTER
DFCI Protocol No.:
OHRS USE ONLY
OE #:
MAJOR DEVIATION/VIOLATION/EXCEPTION OTHER EVENT REPORTING FORM
Instructions:

This form should be used to request IRB approval to deviate from currently approved protocol procedures, request an
exemption from eligibility criteria or to report a protocol violation to the IRB. Other events involving either (1) local DF/HCC
participants or (2) outside Multi-Center Site participants where a DF/HCC investigator is the overall PI should be reported
using this form.

This form may also be used to report any other event which requires review by the SRC or IRB where there is no other
established mechanism to report the other event. Communications to the SRC or IRB from committees such as the Audit
Subcommittee, DSMC or DSMB should be submitted to OHRS using this form.
With respect to protocol deviations, violations and eligibility exceptions, note that:

Changes may not be initiated prior to IRB approval except as necessary to eliminate apparent immediate hazard to subjects
[(45 CFR 46.103(b)(4)(iii) and 21 CFR 56.108(a)(4)]; therefore, amendments must be approved by the IRB prior to
implementation.

A protocol deviation/violation/exemption is a change made to an IRB approved protocol for a single subject. It is not an
amendment to the protocol.

Requests for exceptions or to deviate from the protocol will be triaged by the OHRS staff to a member of the IRB depending
upon the level of urgency.

Investigators are responsible for knowing the reporting requirement to their institutional risk management department. Please
make sure that any reported other events, if appropriate, have also been reported to the applicable risk management group.

Documentation of sponsor acknowledgement and/or approval is required for all sponsored trials. This includes
approval from the overall PI where that individual is the sponsor of the trial. Deviations may not be reviewed by a member of
the IRB until documentation is provided.
o Note: CTEP will not issue or approve any eligibility waivers for protocol deviations. This CTEP policy
applies to all components of CTEP-approved protocols, including eligibility criteria, treatment schedules, dose
modifications, toxicity assessment, response criteria, and statistical aspects.
Please call the OHRS with any questions at (617) 632-3029.
Part A – Study Information
Protocol Short Title:
Today’s Date:
Overall Principal Investigator:
Institution:
[First Name, Middle Initial, Last Name, Degree(s)]
Phone:
[PI Institution]
Email:
Regulatory Sponsor:
Disease Program: [pull down]
-ORDiscipline Program: [pull down]
[Refer to Protocol Front Sheet for study Disease or Discipline Program name]
Part B – Report and Site Information
1. Event Description for OHRS Correspondence: (255 Characters or Less)
Major Deviation/Violation/Exception Form
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DFCI IRB – Major Protocol Deviation/Violation/Exception/Other Event Reporting Form - Continued
2. What type of a Report is this? (Select Only One)
Exception - Any protocol deviation that relates to the eligibility criteria, e.g., enrollment of a subject who
does not meet all inclusion/exclusion criteria. Prospective review is requested by (provide date):
Deviation - Any departure from the defined procedures set forth in the IRB-approved protocol requested
prior to implementation. Prospective review is requested by (provide date):
Violation - Any protocol deviation that was not prospectively approved by the IRB prior to its initiation or
implementation. If this is a report of an ineligible subject enrolled on the study please answer the following
questions:
a. Please specify the date the ineligible subject was identified:
b. Please specify how the ineligible subject was identified:
c. Please specify the enrollment process followed: [Select One]
If other, please describe the enrollment process:
Other Event - Events that cannot be defined as a Deviation, Violation or Exception. This includes
departmental and committee reporting to the DFCI IRB.
3. Requesting/Reporting Investigator Name:
[First Name, Middle Initial, Last Name, Degree(s)]
Phone:
Email:
Institution:
4. Site Involved in this Event:
[Note: If this site is not participating under the DFCI IRB, and a DF/HCC investigator is NOT the overall PI of the study,
please do not complete this form.]
a. Please specify who manages the conduct of this research: [Select One]
If other, please specify who at your institution manages the conduct of this research:
5. Is this other event being reported on behalf of a DF/HCC committee?
No
Yes - If so, by what committee (CLC, SPRC, DSMB, DSMC, Audit, etc.):
Please submit/attach relevant correspondence for IRB review and complete Part B as applicable.
6. Name of Contact for questions about this submission:
Role on Study:
Phone:
Institution:
Email:
Part C –Event Information
1. PARTICIPANT INFORMATION AND REPORT DATES
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DFCI IRB – Major Protocol Deviation/Violation/Exception/Other Event Reporting Form - Continued
a) Participant Study I.D. number and/or Initials:
b) Date of Event:
[If this is a report of an ineligible subject, please provide the date the subject was registered.]
c) Date of Report to Sponsor:
2. EVENT DESCRIPTION - Please describe the event:
a) Please provide and/or describe the applicable protocol pages/sections, regulations or policies that relate to this
event:
b) Does this event involve Pharmacy (e.g. Chemotherapy Orders) and/or Nursing Administration?
No
Yes, please describe:
1. Does this event affect Chemotherapy Orders in BOE, COE or Epic:Beacon/Willow?
No
Yes
c) If applicable, please provide the participant outcome (e.g. was the subject informed of the event?):
d) If applicable, has an incident report been filed with the reporting institution?
No
Yes, please provide the date filed and if available please provide the outcome of the incident report:
3. RISK/BENEFIT ASSESSMENT - Please describe the net effect on the risk/benefit ratio [Required]:
4. REQUIRED CORRECTIVE ACTION PLAN - Please describe the corrective action plan that will be put into place to
prevent this deviation/violation/exception from happening again:
5. PROTOCOL AMENDMENT - Will a protocol amendment be submitted as a result of this reported event?
Yes - If yes, when and what changes/revisions will be proposed?
No - If no, why is an amendment not necessary at this time? If not applicable, please explain why:
6. SUBJECT NOTIFICATION – Will subjects be informed of any new information a result of this reported event?
Yes - Please specify the plan for notifying the subject:
No - Please explain why not:
Not Applicable to this event.
Part D –Statement of Reporting Investigator
Form completed by:
Name:
Date:
Phone:
E-mail:
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DFCI IRB – Major Protocol Deviation/Violation/Exception/Other Event Reporting Form - Continued
The Reporting Investigator assures that the information provided in this submission is complete and accurate. The
Overall Principal Investigator (PI name:
) has reviewed this report and assures that all activities will be
performed in accordance with state and federal regulations and the Dana-Farber/Harvard Cancer Center Polices and
Procedures.
Name of Reporting Investigator:
IRB Determination
Submissions received by the Office for Human Research Studies eligible for expedited IRB review will be reviewed
by an IRB member via an electronic workflow. A separate Electronic Review Documentation Form or Review
Workflow will document any expedited IRB review determinations. Submissions not eligible for expedited IRB
review will be reviewed by the Full IRB and the meeting minutes will document the review determination.
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