Introduction

A protocol deviation is a subject specific variation from the study design or procedures defined in the approved protocol. It is not implemented or intended as a systematic change. A protocol deviation waiver can be defined as the sponsor's approval for a prospective protocol deviation. Such deviations often involve (but may not be limited to) the recruitment of a subject who does not meet all eligibility criteria as detailed in the protocol.

Waiver Request for a Protocol Deviation

This protocol deviation process exists of different steps:

Request a

Waiver (Site)

If the result for an eligibility test is falsefailed, a PI can request a waiver for that subject. 

To do so, a reason must be provided. Then click the 'Request a Protocol Deviation' button.

The request is submitted to the sponsor. The PI can still:

1. • Add more information to the request by pressing the 'Add Message' button;.
   • Or discontinue the request while request, while it is still in consideration with the Sponsor sponsor, if the deviation becomes obsolete. A reason has to be provided then.

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Answer on a

Waiver Request (Sponsor)

The tab 'Protocol Deviations' in the Clinical Data module is designed to have an overview of all requested waivers.It  It lists all protocol deviation waiver requests for all Studies studies in which the user has the right to manage protocol deviation waivers in different statusesview/manage the eCRFs.

The different sections are:

• Outstanding protocol deviations (waiting an answer from the Sponsorsponsor);
• Protocol deviations waiting site confirmation;
• Closed protocol deviations;
• Discontinued protocol deviations.

The sponsor can take for each false criterion one of the following decisions:

• The protocol deviation can be accepted;
• The protocol deviation cannot be accepted;
• More clarification can be requested.

If all false criteria are overridden, the general result is also overridden.

After that confirmation by the Sponsor, the Site :

• Grant the waiver;
• Decline the waiver;
• Request more information.

After the confirmation by the sponsor, the site will see the decision taken in the corresponding activity in the Study Flowstudy flow.

Confirm the

Protocol Deviation Waiver (Site)

If the waiver is granted ('false' result overridden), the Site site is able to decide with which result they continue.

• The Acknowledge decision: the granted deviation can be accepted by the Sitesite. The Subject subject can then continue as if the result was true.
• In Discontinue: in some situations, it might be in the benefit of the Subject subject to continue with the 'false' result, even if the waiver was granted. The Site site then declines the deviation granted; a clarification will be needed.
  Based on new information, received after the waiver, the Site site decides it is in the benefit of the patient to start other treatment.
  

View

For users with ClinicalData.StudyRead rights, it is possible to see a list of protocol deviations by Study, Subject and status of the waiver (outstanding, waiting site confirmation, closed or discontinued).

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Protocol Deviation Requests

All protocol deviation requests of Subjects for subjects in Studies studies a user has read access to will be shown. The list can be filtered on Studystudy.