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 false, 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 it is still in consideration with the sponsor, if the deviation becomes obsolete. A reason has to be provided.

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 lists all protocol deviation waiver requests for all studies in which the user has the right to view/manage the eCRFs.

The different sections are:

• Outstanding protocol deviations (waiting an answer from the sponsor);
• 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 waiver can be granted;
• The waiver can be declined;
• More clarification can be requested.

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

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

Confirm the Protocol Deviation Waiver (Site)

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

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

View Protocol Deviation Requests

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