Setting up subject registration

1. Select View > Study Details or click the Study shortcut button located on the toolbar beneath the menus.

2. Select the Registration tab to display the Registration window.

3. Select the trigger point by selecting a visit and an eForm from the Subject Registration occurs after drop down lists. Once this eForm has been successfully completed, a message will be displayed asking if the data entry user would like to proceed with the registration of the current subject. If the eForm contains any mandatory questions, these will need to be completed before the message will be displayed.

4. Click Settings and select the type of server that you will be using. If None is selected, registration is not enabled. If you wish to use registration with a standalone machine, a web server or a group of network clients, you should select Local.

5. When a subject is registered, they will be assigned an identifier. This identifier will be incremented by one each time a new subject is registered. Enter the Start Number from which you want the identifiers to start.

6. Enter the Minimum Number Width for the identifier. The width determines the number of leading zeroes that will be added before the identifier. For example, if you have specified a number width of  5, the identifier 4 would be displayed as 00004. The identifier 345 would be displayed as 00345 and so on.

7. If you wish to add a prefix or a suffix to the subject identifier, enter an expression into the Subject Identifier Prefix/Suffix Expression fields, either by free typing, or by clicking the fx button and using the expression builder.
   The value returned by the expression will be used as the prefix/suffix.
   The subject identifier is incremented by 1 each time a new subject is registered. If the prefix/suffix is changed, the numbering continues to increment unless the Restart numbering for new pre/suffixes boxes are checked. This results in the numbering being restarted for all identifiers with the new suffix/prefix. See example

   The following examples show each of the 2 options (with the box unchecked and with the box checked) with the same set of 5 subjects. In this example, the site codes are being used as the prefix to the identifier:

   Unchecked	Checked
   london0001	london0001
   london0002	london0002
   sydney0003	sydney0001
   london0004	london0003
   paris0005	paris0001

8. If you wish, you may enter a set of Registration Conditions to ensure that the subjects meet some of the necessary criteria for the study. These conditions must be met in order for registration to continue. If one or more of these conditions is not met, registration will be halted and a message will be displayed, informing the user that a condition has not been met.
   Enter a code and an expression for each condition. You may enter the expression either by free typing, or by clicking the fx button and using the expression builder.
   The value returned by the expression will be used as the condition. If using expressions that relate to questions in the study, ensure that these questions are located before the point at which registration is set to take place.
   We suggest that you use information from the inclusion/exclusion eForms to create the conditions.
   For example, screening:inclusion:age > 18  indicates that the age question on the inclusion eForm of the screening visit must be answered with a number higher than 17 for registration to continue. This would be a useful condition if the study is only open to over 18's.
   Registration conditions are sometimes referred to as Eligibility Conditions.
   The Arezzo Terms report in the Study Data Diagnostic Utility module can be used to list all existing registration conditions in a study definition.

9. If you wish, you may enter a set of Uniqueness Checks to ensure that no subject is registered more than once. Once registration has begun, the system will match the set of checks for the current subject with those of all previously registered subjects. If any complete matches are made, registration will proceed no further and a message will be displayed, informing the user that the uniqueness checks have failed. All the checks need to be matched for this to happen. It is possible to match 4 out of 5 checks and still continue with registration.
   Enter an identifying text code and an Arezzo expression  for each check. You may enter the expression either by free typing, or by clicking the fx button and using the expression builder.
   The value returned by the expression will be used as the check value. If using expressions that relate to questions in the study, ensure that these questions are located before the point at which registration is set to take place.
   We suggest date of birth, gender and initials as a useful set of checks.
   For example, screening:cover:DOB indicates that the response to the DOB question on the cover eForm of the screening visit will be checked against the same value for all other registered subjects.
   The Arezzo Terms report in the Study Data Diagnostic Utility module can be used to list all existing uniqueness checks in a study definition.

If registration fails for a subject, this does not automatically disallow further data entry for that subject. If you want this to be the case, you need to create an internal trigger on all following eForms (or visits) to prevent them opening unless a subject identifier exists for that subject. To do this:

1. Open the Arezzo Composer by clicking the Arezzo shortcut button located on the toolbar beneath the menus.

2. Select the plan representing the first visit or eForm you want to be disabled. Note that this must be different from the eForm which actually triggers registration.

3. In the Task Attributes table to the right of the screen, locate the Internal trigger field.

4. Enter isknown (person:subjectidentifier)

5. Repeat steps 2 to 4 for all other visits or eForms in the study that depend on registration.

6. Click Save at the top left of the screen and close the Composer by clicking the button at the top right.

When randomisation is set up in MACRO, registration is carried out in a special way.