Data Entry/Review module

Entering subject data

To enter data, you need both the 'View data' and 'Change Data' permissions

1. Open the schedule for a subject and open an eForm.

2. Use the Tab key on your keyboard to move through the eForm from the top to the bottom. This ensures you answer the questions in the order specified by the study designer.

3. When you land on a question, its entry field becomes yellow. This indicates that it is active and ready to have data entered. Hover the mouse over the question field to see a tooltip containing basic details about the question. More details

   The information in this tooltip has been specified by the study designer when setting up the study.

   Name	This is the name of the question. This is different from the question caption which appears on the eForm next to the question field.
   Code	This is the unique identifier for this question.
   Type	This indicates the question type. There are 7 types, each one requiring a different type of answer. Click here to go to more information on question types. If the question response has been derived (automatically filled in based on the answer to another question) this will be indicated in brackets after the question type.
   Format	This indicates the format in which this question must be answered. The format depends on the question type.
   Help Text	This is information provided by the study designer to help you answer the question.

4. If a question and its entry field appear greyed out, you cannot answer this question. Why is this?

   There are several causes of a grey question:

   • Some questions have their answers automatically filled in based on answers that are given elsewhere. These are known as derived questions and cannot be changed except by altering the answer to other questions.

   • Some questions may only be enabled if a previous question has received a specific answer. For example, if previous answers have identified the subject as male, any questions about pregnancy would automatically be skipped and displayed as grey.

   • The question may have been frozen or locked by a data reviewer, which means that you are not able to change the response.

   • If all the questions on an eForm are greyed out, the eForm may have opened in 'read-only' mode.

5. If a question field appears greyed out but contains an answer, this answer has been derived from information that you have already entered elsewhere.

6. Enter the data and press the Tab key to move to the next question. A status icon appears next to the question you have just answered. Hover the mouse over the status icon to see a tooltip containing details about the status of the question. More details

    

   Status	This indicates the status of the question.
   Freeze/lock	This indicates whether or not the question has been frozen or locked in order to prevent anyone making changes to it.
   DCR	This indicates whether or not any DCRs have been raised against this question and if so, the status of the DCR.
   SDV	This indicates whether or not any SDV marks have been created for this question and if so, the status of the SDV.
   Note	This indicates whether or not any notes have been attached to this question. A note is a simple piece of text, attached to an individual question.
   User name	This is the User Name of the user who entered the response.
   Time stamp	This is the date and time at which the response was entered.

7. You can right click the status icon to see the Question Context Menu from which many options can be accessed.

8. Different types of questions need to be answered in different ways.  Help on question types..

9. There is often an eForm or visit date question near the top of the eForm. If so, this must be filled in before you can leave the eForm. To enter the current date, enter t.

10. To remove a question response, click in the question field and press the F9 key on your keyboard.

11. When you reach the end of the eForm, save your data and move to the next eForm.

12. If you remain on an eForm for longer than the specified 'timeout' period (default time = 20mins), MACRO will assume that you have quit the session and will automatically log you off.  If you then try to save the data you will be asked to login and any unsaved data will have been lost.

Disallowed characters

MACRO does not accept the following characters when entering subject data  " ` ~ |

Popup messages

From time to time and especially when you try to save data, a message may appear, giving you information or requesting action. In many cases, the eForm cannot be saved until you have responded and re-attempted the save. Help on the most common messages...

Changing a question response

To change a question response, you need both the 'View data' and 'Change Data' permissions

If you need to change a saved question response, simply click in the entry field and replace the response. Depending on how the question was set up by the stuy designer, you may be asked to select a reason for the change (RFC). Your selected reason will be stored in the question's audit trail with the new response.

Labelling a question as 'Not Available'

To toggle the status of a question between 'Missing' and 'Not Available', you need boththe 'View data' and 'Change Data' permissions

If it is not possible to obtain an answer for a question, you can manually change the status of the question from 'Missing' to 'Not Available'. How to change between statuses

Note that this status does not mean that the question is locked. Data can still be entered if the question is marked as 'Not Available'.

You can change the status back to 'Missing' at any time.

Related Topics

Opening an eForm

Saving data and moving between eForms

List of common popup messages

About question types