Chapter 1. Introduction

Table of Contents

1.1. Objective
1.2. Approach
1.3. The Kit
1.4. Instructions
1.5. Notes
1.6. How to start DFATK
1.7. How to start DFexplore
1.8. How to start DFsetup
1.9. How to start DFsend

1.1. Objective

The objective of the Acceptance Test Kit (ATK) is to provide DFdiscover clients with an acceptance test plan which can be executed to:

  • Verify the correct installation of the DFdiscover software in their own environment.

  • Confirm the core DFdiscover functionality in their own environment.

  • Demonstrate, by means of passed tests, correct operation of tested functionality and core requirements of the DFdiscover software.

1.2. Approach

The Acceptance Test Kit has these features:

  • Functional approach - i.e., based on meeting data management objectives.

  • Follows a logical data flow and processing path from user's viewpoint.

  • Starts with a complete study already setup using the DFdiscover software.

  • A series of tests organized within modules, are linked to the core requirements of the DFdiscover software. These modules are core to the use of the ATK. Each module has a start action, a detailed script of user steps and an end action.

  • User is given defined input and expected output for objective verification.

  • Not an exhaustive test of every button, menu or GUI in every DFdiscover application.

1.3. The Kit

The Acceptance Test Kit contains:

  • Manual: descriptions of tests, organized within functional modules.

  • Control Panel application and instructions for setting the study to base state. The Control Panel application controls the start, stop and interim states of all modules.

  • Study: simple blood pressure study already setup, which includes plate definitions, edit checks and look-up tables.

  • Database: includes several completed subject cases existing at various states (i.e., entered data, submitted and awaiting data entry, awaiting outbound transmission, or EDC data entry).

  • Case Report Forms.

1.4. Instructions

To perform the Acceptance Test Kit:

  • Module 1 provides instructions on installation and initialization. Module 1 must be completed first.

  • The Control Panel application sets each module to a known base state. Use the Begin button to start each module.

  • Modules are presented in logical order from study setup to data entry and reviews. Any module, beginning with module 2, can be skipped if it deals with topics that are not relevant to your use of the software.

  • Within each module, tests must be executed in order.

  • Execute module completion, by clicking End once all module tests have been performed.

  • Complete test summary and, if necessary, discrepancy reports.

1.5. Notes

  • Every module uses DFATK and must be run as datafax. Refer to Module 1 (Installation & Initialization).

  • References to DFdiscover Server value will be the name of your DFdiscover server.

  • Images in this manual are of the applications running in the Windows 10 operating system. If you are running the applications on macOS, the appearance of the windows, dialogs and default button layouts will differ slightly from those shown here.

  • Screen colors may appear as a black background with a white CRF foreground. These are the DFsetup default colors. The colors in illustrations have been modified (reversed) for clarity.

  • If you do not have a printer connected to the DFdiscover server (e.g. if you are a hosted client), a valid email address is required for data_coordinator, data_manager, site_monitor or site_invest to receive all module specific PDF files. Refer to Creating a role and permissions for data_coordinator, data_manager, site_monitor or site_invest, Step 5.

1.6. How to start DFATK

  • Start DFATK. DFATK is also known as the Control Panel, in the DFATK login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.). As the Control Panel must be run as datafax, the Username field cannot be edited. Enter the previously specified password for datafax and click Login.

1.7. How to start DFexplore

  1. Start DFexplore. In the DFexplore login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.) Enter data_coordinator, data_manager, site_monitor or site_invest in the Username field and the previously assigned password in the Password field. Click Login to login.

  2. During the first login of data_coordinator, data_manager, site_monitor or site_invest a new password must be chosen. Choose and enter a new password in both the New Password and Confirm Password fields. Click OK to set the new password and dismiss the dialog. Choose 254 Acceptance Test Study, click Continue. If your DFdiscover server does not allow the re-use of previous passwords, you will be required to set either data_coordinator, data_manager, site_monitor or site_invest's password to something other than the initial password chosen previously. The password you choose must satisfy the password requirements specific to your DFdiscover server and will be needed in the remainder of the modules.

1.8. How to start DFsetup

  1. Start DFsetup. In the DFsetup login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.) Enter data_manager in the Username field and the previously assigned password in the Password field. Click Login to login.

  2. In the studies selection dialog, highlight the entry for 254 Acceptance Test Study. Click Continue to continue.

1.9. How to start DFsend

  • Start DFsend. In the DFsend login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.) Enter data_coordinator, data_manager, site_monitor or site_invest in the Username field and the previously assigned password in the Password field. Click Login to login.