Chapter 7. Module 7. EDC Data Entry

Table of Contents

7.1. Tests & Requirements
7.2. Begin Module 7. EDC Data Entry.
7.3. Login to DFexplore and inspect the list of sites, subjects and visits in the record list window.
7.4. Enter and save new data using EDC data entry for Subject 99007.
7.5. Add reasons to explain entered data values.
7.6. Enter and save Plate 3, Subject 99007 as a pending record.
7.7. Mark and save unavailable data as missed. Unmark available data as missed.
7.8. Retrieve and modify existing data using a predefined task and save modifications to the database.
7.9. Confirm audit trail information for entered and modified data.
7.10. End Module 7. EDC Data Entry.

7.1. Tests & Requirements

  1. Login to DFexplore and the Acceptance Test Study and confirm the list of sites, subjects and assessments in the record list window.

  2. Enter and save new data using EDC data entry for Subject 99007.

  3. Add reasons to explain entered data values.

  4. Enter and save Plate 3, Subject 99007 as a pending record.

  5. Mark and save unavailable data as missed. Unmark available data as missed.

  6. Retrieve and modify existing data using a predefined task and save modifications to the database.

  7. Confirm audit trail information for entered and modified data.

Estimate of Time Required: 20 minutes

7.2. Begin Module 7. EDC Data Entry.

Every module uses DFATK and must be run as datafax.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click 7. EDC Data Entry followed by Begin to begin this module.

  3. Click Send ID 99007 to email a copy of ID99007_module7.pdf to site_monitor. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Refer to Section 1.8, “Creating user accounts and assigning study permissions.” as a valid email address is required for site_monitor to receive the module specific PDF files.

    Wait 2-3 minutes prior to proceeding to DFexplore.

7.3. Login to DFexplore and inspect the list of sites, subjects and visits in the record list window.

  1. Start DFexplore, login as site_monitor and choose 254 Acceptance Test Study as described in Section 1.7, “How to start DFexplore.

  2. Confirm that only Site 99 - Hospital #99 is available.

  3. Double-click entry for Subject 99001 to select and open the subject binder. A list of available visits is displayed.

  4. Double-click entry for the highlighted 1 : Baseline visit to display the list of pages belonging to the visit.

  5. Close the subject binder for Subject 99001 by double-clicking Site 99 - Hospital #99 in the record list panel.

7.4. Enter and save new data using EDC data entry for Subject 99007.

  1. Using the paper CRFs that were printed or emailed at the beginning of this module (Step 2). Select Select > Change Mode & Level to set the working mode and data entry level. In the dialog, set:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Check Enable edit checks

    Click OK.

  2. Double-click Site 99 - Hospital #99 entry in the record list panel. Double-click Subject 99007.

  3. Double-click the 0 : Screening Visits entry to display all pages belonging to the visit.

  4. 1 : Form 1 becomes the active page. The data window redraws with the plate background and related data entry fields.

  5. Click anywhere on the plate background - this moves the mouse and keyboard focus to the data window.

  6. Beginning at the Patient Number field, press Tab to advance to the Patient Initials. Enter the initials as they appear on the printed CRF. Press Tab to advance to the next field.

  7. Continuing from the Age field, press Tab to advance through the fields individually. Enter all remaining data as it appears on the printed CRF. Although leading zeros may not always appear on the paper CRF, be sure to enter leading zeros where necessary. After entering the Eligibility Criteria #6, press Tab to make the save buttons active.

  8. As no data problems exist on the entered page, the page can be saved to the database with a Final status. Click Final.

7.5. Add reasons to explain entered data values.

  1. To open a new visit for Subject 99007, double-click the entry labeled 1 : Baseline in the record list panel.

  2. Click anywhere on the plate background - this moves the mouse and keyboard focus to the data window.

  3. With Patient Number as the active field, attempt to edit the pre-filled value, note that this is not possible. Press Tab to advance to Patient Initials. The SetInit edit check executes upon entry to the field. If the initials are available on the 1 : Form 1 (previously entered), they are brought forward and populate the Patient Initials field.

  4. Press Tab to advance through each field and enter the data as it appears on the printed CRF, up to and including Weight (lbs). Press Tab to exit the Weight (lbs) field and execute the WeightEquiv edit check. The WeightEquiv edit check calculates and enters the equivalent value in the blank Weight (kg) field.

  5. The HeightEquiv edit check is similar to the WeightEquiv edit check. If only one of the two height values are entered, the edit check calculates and enters the equivalent value for the blank field. Press Tab to exit the Height (in) field and enter the value as it appears on the printed CRF (including leading zeros). Press Tab to exit the field.

  6. Enter all remaining data on the page as it appears on the printed CRF, up to and including the Pulse field. Press Tab to advance to the Smoking Status field.

  7. Select Field > Add Reason For Data Value or click in the Reason for Data Value window. In the resulting dialog, choose Approved from the pull-down list.

  8. Enter the text Smoking Status data will be provided once contact has been made with the patient. for the Reason property. Click OK, press Tab to advance to the Exercise field.

  9. Select Field > Add Reason For Data Value or click in the Reason for Data Value window. Choose Pending from the pull-down list.

  10. Enter the text Exercise data will be provided once contact has been made with patient. for the Reason property. Click OK, press Tab to advance to the Date of First Study Follow-up Visit field.

  11. Enter the Date of First Study Follow-up Visit and press Tab to advance to the save field. Verify that Final is highlighted. Do not save the page with this status as the Smoking Status and Exercise fields have yet to be completed. Click Pending.

7.6. Enter and save Plate 3, Subject 99007 as a pending record.

  1. Subject 99007 3 : Form 3 becomes the current record. Click anywhere on the page background to make the fields active for entry.

  2. Starting at the Patient Number field, press Tab to advance to the Patient Initials field. The SetInit edit check executes upon entry to the field.

  3. Continuing at Patient Initials, press Tab to advance through each field and enter the data as it appears on the printed CRF. The medical conditions that appear pre-printed on the CRF page have been defined as constant values in the study setup. As a result, these fields cannot be edited. Press Tab to advance to the save buttons. As data for Major Surgery is not yet complete, click Pending to save the page with status Pending.

7.7. Mark and save unavailable data as missed. Unmark available data as missed.

  1. Baseline 4 : Form 4, Pg 1 is now the active page. As no data is available for this page, select Plate > Set Page Missed.

  2. In the dialog, choose Data not available value from the Reason pull-down list. Enter Medication information is missing from patient's chart. as the Detail.

  3. Click OK to register the page as missed.

  4. Double-click Subject 99005 in the record list. From the now open list of visits for that subject, double-click the 1 : Baseline visit.

  5. All pages for that visit are displayed.

  6. Choose 3 : Form 3. Select Plate > Unset Page Missed. In the confirmation dialog, click OK.

  7. Enter the text Patient's chart has been located and Medical History is available. in the Reason field. Click Save to unset 3: Form 3 as missed.

  8. Double-click Site 99 - Hospital #99 entry in the record list. This closes all open subject binders for Site 99 - Hospital #99.

7.8. Retrieve and modify existing data using a predefined task and save modifications to the database.

  1. Select Select > By Task to view the list of predefined data entry and data management tasks.

  2. Click Screening Data Review from the list, then Select to load the task and its selection criteria. This task is used to review all screening plate 1s that exist at level 1 or 2 and save them to level 3. Examine the lower left of the dialog to determine the number of records that match the task search criteria. Confirm that the number is 4.

  3. Click OK to bring forward all records that match the task criteria.

  4. Beginning with the first task record for Subject 99001, press Tab to advance through all fields on the page, comparing their values to those on the CRF image in the image window. When Eligibility Criteria #5 is the current field, select Field > Add Query or click in the Query window.

  5. In the Add Query dialog, set:

    • Category = Other

    • Use = External

    • Status = New query

    • Type = Clarification

    • Detail enter We have not received this patient's informed consent form. Please send it by fax or email without delay.

  6. Click OK to apply the query.

  7. Press Tab to advance through the remaining fields on the page. Once all fields have been traversed, press Tab to make the save buttons active.

  8. Click Incomplete to save the current task record to the database at level 3.

  9. Batch validate the remaining records in the task list to raise their level to level 3. Select Select > Batch Validate. In the dialog, set:

    • Move record level to = 3 - Level 3

    • Choose All currently selected task records

    Click Batch Validate.

  10. Enter Username of site_monitor and the corresponding password in the verification dialog. Click OK to batch validate the task records to level 3 and dismiss the dialog.

  11. Review the details in the summary dialog. Click OK to close the summary dialog and complete the batch validation operation.

7.9.  Confirm audit trail information for entered and modified data.

  1. Return to Subject 99001 > 0 : Screening Visits > 1 : Form 1.

  2. Select Plate > List History of All Changes on This Page to display the current record's history.

  3. Click Close to close the Page History dialog.

  4. Select File > Exit menu to close and exit DFexplore.

7.10. End Module 7. EDC Data Entry.

  • Return to the DFATK application. Click End to confirm successful completion of Module 7. EDC Data Entry.