Deviation

What is a Deviation?

A deviation is an unintentional action or process that departs from the IRB approved study protocol that is identified retrospectively (after the event occurred). If the deviation disrupts the study design or compromises the safety and/or welfare of a subject or subjects, the deviation must be reported to the IRB within 10 business days.

How do I submit deviations?

To submit a deviation in real time (within 10 days):

Start by downloading the deviation report form (required after June 1,2016)

Paper Studies: After completing the submission form, please print and send to the IRB office with one copy of each required supporting document. PI signature is required for all paper submissions.

HSERA Studies: Follow these steps for creating a Deviation in HSERA:

1. After completing the submission form, save it to your desktop. PI signature on the form is NOT required when submitting in HSERA

2. Go to HSERA.

3. In the blue menu on the left side of your screen look for "Create" under "My Submissions".

4. After clicking "Create" you will be brought to a new screen where the various electronic application types are available. Click "Deviation"

5. After clicking "Deviation" you will be brought to a screen with a list of all HSERA studies for which you are listed as either PI, Co-PI or Study Contact (note that Key Personnel cannot create submissions). Check to make sure your filter is clear. Then enter the protocol # you wish to make a Deviation for and click "Filter".

6. After clicking "Filter" with the specific protocol number entered, you should see one entry with columns showing the PI name, Submission date, Title, and a Select column - click the white and yellow "Select" button.

7. After clicking the "Select" button you will be taken to the first page of the Deviation submission

  • Page 1 requires that users answer questions similar to those questions in the downloaded form that you already completed in Step 1. The IRB will refer to your attached form – NOT the electronic answers on page 1 of the Deviation application. Currently the system requires responses to all questions on page 1. You should fill in accurate dates for the first 2 questions. Fill in all text boxes with “NA” or “0” or “See attached” to get through this section quickly (In the future the system will be updated to remove these questions and provide an area to attach your completed form). All the relevant information that the IRB requires will be provided in your attached form. When you get to the end of page 1, click “Next”
  • Page 2 of the Deviation application is where you attach your completed form (from Step 1). You can attach as many documents as necessary in this section.
  • Once the completed Deviation form and supplemental documentation are attached to the application, go to the bottom of the page and click “I accept” – your Deviation submission is now complete.

To report deviations at the time of continuing review:

If your study experienced some minor deviations during the year that did not require immediate reporting, you may submit a summary of those events with your continuing review. Please note the following when drafting the summary:

  • The document may be in the form of narrative summary or a deviation log,
  • The summary must include the following: 1) when the deviation(s) occurred, 2) a description of the deviation(s), 3) assessment as to whether the deviation(s) placed participates at increased risk of harm, could occur again, or could qualify as serious or continuing noncompliance, 4) if and when the deviation(s) were previously reported to the IRB, and 5) any corrective actions put in place in response to the deviation(s).
  • A sample deviations log is shown below:

 

Date of Deviation

Deviation Description

Subjects placed at increased risk?

Previously Reported?

Corrective action Plan

If ongoing - specify

a brief description of the deviations that occurred,

 

an explanation as to whether any deviations placed participants at increased risk of harm, has the potential to occur again, or the has the potential to qualify as serious or continuing noncompliance

an indication of any events that required real time reporting to the IRB and the dates when they were reported,

 

A summary of any corrective action plans implemented to avoid similar deviations in the future.

 

 

Please note that if an investigator knows in advance that the protocol will be deviated from for any reason, an exception request should be submitted prior to implementation of that altered process. Please note that exception requests submitted after implementation will be considered deviations regardless of prior approval from sponsors or medical monitors. Please see the “How to Submit” page about exception requests for more information.

 

Steps:

Submitting to the IRB

HS-ERA Link: https://medley.isc-seo.upenn.edu/hsProtocol/jsp/fast.do

Submission Process

To submit a deviation to HS-ERA, click "create" and "deviation" which will take you to the deviation specific section of the modification form.  Select the protocol you are submitting the deviation for.  NOTE: If the protocol is not available, the protocol is either a paper study or the submitter does not have edit access to the protocol.

Paper Studies

Paper Studies: Please use the deviation form and submit via interoffice mail with hard copies of the accompanying documentation. 

NOTE: Deviations of an urgent nature may be submitted via email.

Who do I contact with questions?

For assistance with submitting a deviation or to determine if a deviation needs real-time submission: Please contact either Patrick Stanko or Dave Heagerty or review SOP 404 guidance for reporting criteria.

Completing the Deviation Submission

Deviation Form

Please complete the sections of the deviation form in its entirety. 

Any additional information needed for the IRB to assess the potential impact on subject safety, data integrity or an overall impact on the research will need to be provided.

 

Who can I contact with questions?

For assistance with completing the deviation reporting form, please contact either Patrick Stanko or Dave Heagerty.

Confirmation Page - Documents to Include

Additional Documentation

Any additional documentation needed to assess the deviation will need to be uploaded, including a cover letter outlining the deviation and any proposed corrective action plan(s), any Sponsor documentation related to the deviation, if appropriate, etc.

 

Who do I contact with questions?

If you require assistance with additional document to provide with the deviation submission, please contact either Patrick Stanko or Dave Heagerty.

IRB Review Process

IRB Review/Assessment of the Deviation

The IRB will consider the deviation and take one of the following courses of action: 1) acknowledge the deviation with no further review required, 2) acknowledge the deviation but require additional information or corrective action, 3) acknowledge the deviation and require convened review of the deviation or 4) acknowledge the deviation, require convened review and require additional information in order to assess the deviation at the convened board.

 

Reporting noncompliance

Note: Any deviations requiring a formal noncompliance assessment by the convened board will result in a formal letter to the PI noting the determination related to the noncompliance, and whether this determination requires any internal or external (FDA, OHRP, Sponsor) reporting.

 

Who can I contact with questions?

If you require assistance with this step in the process, please see the directory and contact any Senior Administrator.

Responding to Issues Raised by the IRB

IRB notification(s) for additional information required

If additional corrective action(s) or other responses are required by the IRB, they will be requested via the formal letter that either notes acknowledgement of the event or notes acceptance of the event by the convened board.  For HS-ERA studies, the submission WILL NOT be returned, but a follow-up submission will be required to respond to the issues raised by the IRB.

 

Who can I contact with questions?

If you require assistance with this step in the process, please see the directory and contact any Senior Administrator.