Contents

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 an eligibility test failed, 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:

- 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 then.

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:

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 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.

Information

Outstanding protocol deviations are those waiver requests that are requested by the site, but for which the sponsor did not take any decision yet.
Protocol deviations waiting site confirmation are those waivers that are decided (granted or not) by the sponsor, but for which the site did not acknowledge or decline yet.
Closed protocol deviations are waivers that are acknowledged by the site.
Discontinued protocol deviations are waivers that the site declined.