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The Clinical Data module integrates subject enrollment, electronic data capture and clinical data management features. Subject enrollment includes registration, and can include other activities, such as randomization, defined as enrollment activities. The system tests inclusion and exclusion criteria, performs dynamic eligibility checks and facilitates protocol deviation management.

Real time edit checks are run at time of data input and automatic queries are generated at time of submission of the case report forms. Conditional triggering of data and a dynamic study flow (activities based on protocol visits/assessments) facilitate data input and improves the completeness of the submitted data.

Electronic signatures are collected both for the clinical data as well as for the activities. All changes applied to the clinical data by any of the users are tracked and documented in the audit trail which is accessible at several levels.

Contents
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Studies overview

The studies overview tab in clinical data shows all studies for which the user has access.

  • screenshot to be inserted with clean study overview

Protocol deviations

Introduction

 

 

 

 

Protocol deviation waiver request process

This protocol deviation process exists of different steps:

Request a protocol deviation 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:

    • 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 protocol deviation waiver (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 manage protocol deviation waivers in different statuses:

  • 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 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 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.

  • The granted deviation can be accepted by the Site. The Subject can then continue as if the result was true.
  • 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.
    (green star)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

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).

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

(info) 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.
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