DFCI Protocol No.: Log #of
Submitted w/ CR#:
Institution:
Study teams are responsible for maintaining this log within the overall regulatory binder.
- For sponsored trials, proper documentation of sponsor acknowledgement and/or approval for each deviation is required and must be attached to the log.
- If 3 or more minor deviations/violations of the same type (or for the same subject) are found in the Log to impact the safety of participants, compromise the integrity of the study data and/or affect subject’s willingness to participate in the study, the events must be submitted to the IRB via the Major Deviation Form.
- The overall study team is responsible for maintaining the deviation log and submitting it to the IRB with the continuing review.
- Please do not include previously IRB reviewed minor deviations/violations.
Part A – Study Information
Protocol Short Title:Today’s Date:
Overall Principal Investigator:Institution:Phone:
[First Name, Middle Initial, Last Name, Degree(s)][PI Institution]
Part B – OVERALL PI ATTESTMENT
The Overall Principal Investigator assures that the information provided in this submission is complete and accurate, and that it is consistent with proposal(s) submitted to external funding agencies. The Overall Principal Investigator assures that all activities will be performed in accordance with state and federal regulations and Dana-Farber/Harvard Cancer Center Policies and Procedures.
The Overall Principal Investigator also attests that each event which does not specify that a Major Violation has been submitted to the IRB, particularly those events which have occurred 3 or more times, meet the following reporting requirements:
1. The reported events do not impact the safety of participants;
2. The reported events do not compromise the integrity of the study data;
3. The reported events do not affect subject’s willingness to participate in the study.
Name of Overall Principal Investigator:
Form completed by:
Name: Date:
Email:Phone:
Part C – Deviation Tracking Log
Added to Log Date: / Event Date: / Subject ID /Site / Initials / Type
(V, D): / Code (1-14): / Description of Deviation (including assessment of the net effect on Risk/Benefit): / Reason for Deviation and Date of Sponsor Approval: / Corrective Action Taken
To Avoid Recurrence: / Date Major Violation Submitted to IRB:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
PartD – Code Reference Guide
Event Type: D = Deviation; V = Violation
Deviation/Violation Log
1
Event Type Codes:
1 = Recruitment Procedure
2 = Source Documentation
3 = Withdrawal Criteria
4 = Concomitant Medications
5 = Time Frame
6 = Study Conduct
7 = Informed Consent
8 = IRB Reporting
9 = Administrative Issues
10 = Drug Accountability
11 = Lab Results
12 = Research Sample(s)
13 = Documentation or Forms
14 = Other
Deviation/Violation Log
1
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.
Deviation/Violation Log
1