Chapter 2. Data Entry

Table of Contents

2.1. Selecting a Subject
2.2. Navigating the Subject Binder
2.3. Entering Data / Completing a Record
2.3.1. Data Entry Aids
2.3.2. Data Types
2.3.3. Edit Checks
2.3.4. Saving Data
2.4. Finding Subject Records

2.1. Selecting a Subject

On the Subjects page, click a subject ID from the list to open the subject binder page.

If the subject ID you need is not in the list, click to add a new subject ID. This opens a dialog with two text input fields. Enter the subject ID to add to the current site. Confirm the subject ID by entering it again. Click OK to confirm the subject creation, or Cancel to close the dialog without creating a subject.

2.2. Navigating the Subject Binder

The subject binder page displays the available visits for that subject. Under each visit, the CRFs available at that visit are presented. Click a visit to see the list of CRFs in that visit. To begin data entry, select the appropriate visit and CRF. To change to a different visit or CRF, click in the CRF page header area to return to the subject binder page.

2.3. Entering Data / Completing a Record

2.3.1. Data Entry Aids Focus Indicators

The last in-focused field displays a vertical bar on the left edge of the field. It may contain color information, including red (required and missing or illegal values), blue (outstanding query), green (resolved), orange (pending), and black (otherwise). Formatting

Some fields only accept specific data formats. Field formatting is shown in the blank field to help guide data entry. For example, a date field may have the format YYYY/MM/DD or a lab result field may have the format nn.nn. Legal Ranges

Some fields may have legal ranges defined. If you enter an illegal value, the value turns red, and you are shown a warning similar to: "Input value is not in the legal range." The warning disappears after a few seconds, though the value remains red until corrected. Help

In addition to the description for each field on the CRF, help information may be available for the field. This is indicated with a icon. Click to view the help message. Field Skipping

Keyboard navigation on DFcollect is not standardized on tablet devices, hence field skipping is not implemented. Navigate directly to fields by selecting them. Screens

Some CRFs may be organized into multiple screens. A screen has a main body for data as well as a clickable tab to control visibility. Click a tab to switch to that screen.

If screens are not used on the CRF, the tab bar is hidden.

2.3.2. Data Types Number

Numeric digits (0-9), and a sign symbol (+ or -) can be entered in number fields. If a decimal or other character is required, it is entered automatically to match the required format for the field. String

Except for the | character, any text may be entered in a string field. A maximum field length may be defined which limits the number of characters that can be entered. Date

Use the date picker to select a date. If a date is entered using the keyboard, it must follow the defined format, e.g. DD-MMM-YYYY, YYYY/MM/DD, DDMMYY. Partial dates may only be entered via the keyboard. Time

Enter the time using hours, minutes, and seconds as indicated in the field format. Choice

Only one response option can be selected for each choice field. The field is displayed as radio buttons if there are three or fewer response options, otherwise they are displayed in a drop-down menu. To clear a response on a radio button, click the currently selected radio button again. Drop-down menus show the empty response as the first option - use that to clear the response. Check

A check field can be checked or unchecked. Multiple check fields may be included in one item; check all that apply. Visual Analog Scale (VAS)

Select a point along the scale by clicking that point. Drag the slider to select values more precisely. The selected value is shown above the scale in the middle, with the low and high limits of the scale shown on the left and right respectively. To remove the value, click M, select No Code (Reset) from the dropdown, and click Apply.

2.3.3. Edit Checks

Edit checks are defined during study setup. They are fragments of logic that enforce study expectations for the data collected. They run interactively during data entry and data review. Edit checks may be run when you enter a CRF or a field, or when you leave a CRF or a field. Edit checks perform various actions, such as displaying a warning message, adding a query, calculating data, or changing data to view only.

The following is an example edit check. Your own study will likely have similar edit checks that also display messages and request input. In the edit check example shown below, the edit check has detected an inconsistency in the response. The user is asked to click FIX NOW to return to the data field to make a correction, or click APPLY QUERY to add a query to the field and fix the problem later.

2.3.4. Saving Data

When you have completed data entry on a CRF, you must save your changes before leaving the CRF. To do so, click if you are online, or if you are offline, which are located in the Header Panel. If you are offline, you must remember to upload the changes to the server when you connect to a network. More details on this process, including handling conflicts, can be found in Working Offline.

If you leave the CRF before saving, the following dialog is presented:

Click Cancel to remain on the CRF. Click Save to save your changes before leaving, or click Discard to discard the data on the CRF. If you discard the data, your changes are not saved and cannot be retrieved.

2.4. Finding Subject Records

To return to the Subjects list from a subject binder or CRF, click until you arrive at the Subjects list.

To search for a specific subject ID, click to open the search bar. Type the subject ID into the search bar and click . You are taken to the first subject ID in the list that matches your search. Click and to move to the next or the previous subject IDs that match your search. Clicking takes you back to the first subject ID in the list that matches the search.