secuTrial beginners guide

Overview

The following topics are covered by this documentation:

• Introduction
• CustomerAdminTool
• AdminTool
• FormBuilder
• DataCapture
• ExportSearchTool

Introduction

This manual is intended to give you a rough overview of secuTrial’s functionalities without going into too much detail. Also, it may be helpful as an indicator when you feel lost, which will most likely happen often during your initial user experience. secuTrial is the software we use to set up electronic case report forms (eCRFs) for clinical studies/trials. It has a browser based interface both for setup and data acquisition.

setup

productive

The colors are a good orientation and commonly the secuTrial logo in the top left will help you assess if you are currently viewing the productive or the development environment.

Before we get started please keep the following in mind for future reference:

• If in doubt why something is not working check the account permissions in the AdminTool.

• Never use the browser integrated navigation (←,→,F5). Only use the secuTrial links.

CustomerAdminTool

This is the highest order administration and only has one administrative account. Here you can initialize sub-admin accounts for the different customer areas. These accounts allow you to access the AdminTool. Until you are more familiar with secuTrial you will probably not be using the CutomerAdminTool.

AdminTool

Here you can register projects/trials and create accounts for yourself to setup the eCRF and for customers to test and later capture data. All accounts can be equipped with custom permissions. Furthermore, this is where you can delete patients. Mass removal is possible in the development environment: Patients → select project → clean up → select patients to remove

Creating user accounts

In the CustomerAdminTool you need to register yourself as an admin for an area if you are not registered yet. With this account you can log in to the AdminTool for the specific area. Here you click ”Participant” and then create a ”New participant” (bottom left). Enter first name, last name, user-id, email and password for the new participant. Finally, under Centres (bottom of the page) you specify the project, centre and role for the new participant. ”Save and back” and inform the new participant that the account is active. If the centre does not yet exist it needs to be created. The same is true for the role.

FormBuilder

eCRFs are constructed in the development environment and when they are finished they are transferred to the productive area. First you need to set up the configuration (”Edit configuration”). Then you can start building forms and the visit plan. Forms are made up of questions which are made up of items (Form → Question → Item). Visit plans are a collection of forms that need to be filled over the course of the clinical trial. Data entry is possible in the DataCapture module.

DataCapture

This module allows filling the forms that were created in the FormBuilder with specific data. Within the development area you can enter and delete data in order to test your implementation. Within the productive area extreme care and caution is advised (if in doubt do not enter or delete data).

Reports

Reports are intended to allow secuTrial users to get rough overviews of their acquired data. Report templates can be generated in the FormBuilder. Custom reports can be created by clicking ”Edit reports” and then ”New report”. In some cases it may be necessary to write SQL queries. For this you need to select ”free SQL”. An overview of the underlying table structure can be viewed by clicking the ”i” next to ”SELECT statement”. After creating a report type it needs to be released for certain roles. This can be achieved in the AdminTool via the ”Ressources” panel. The status must be checked for a report to work. If the status is not checked it will not appear in the DataCapture.

Import

In most cases data will be manually entered into the eCRF. However, in some cases batch data needs to be imported. Data imports must be specified in the FormBuilder for each form family with ”Edit import formats”.

ExportSearchTool

At some point the clinical investigators will need an export of their data. Old exports can be viewed in the ”Export history”. If you would like to rerun an export with a previously defined configuration you can click the ”Export again” (round arrow) on the left. This will recreate the export with the currently entered data. A new export can be created by selecting ”Export”. Remember to save your TAN.

This recipe was tested under secuTrial version 5.5.1.10