Some data has no fixed number of entries. A subject has zero adverse events or twelve. Two Builder blocks handle this, and they answer different needs.
š Prerequisite: eCRF Builder (Edit), and a study in Draft or Suspended status.
Which one do you need?
Block | What it does | Use it when |
Repeated measures | The site fills the same set of questions as many times as needed, one entry at a time. | You do not know the number of entries in advance: adverse events, concomitant treatments, medical history, unscheduled assessments. |
Table/Matrix | A grid with fixed rows and fixed columns, filled on one screen. | You know the rows in advance: a PK sampling schedule, the same measure on left and right side, a lab panel. |
Build an adverse event log with Repeated measures
š ļø Step by step guide
Open the form, click Add question and select Repeated measures
Enter a Title, for example "Adverse events", and a description if the site needs guidance
Set the Maximum number of single measures. The default is 20 and the ceiling is 50
Add the questions of one entry: AE term (Text input), start date and end date (Date/time), severity (Radio buttons), relationship to treatment (Dropdown), action taken (Checkbox)
Select Save
A repeated measure holds up to 40 blocks, questions and static content together. It accepts these question types: Text input, Number value, Radio buttons, Checkbox, Dropdown, Date/time and Rating.
š” Tip: put the AE log in its own visit (section) named "Adverse events" at the end of the structure, instead of repeating it at every visit. The site then has one place to record an event whenever it occurs, and you export one list per subject.
ā ļø Warning: set the maximum with margin. When a subject reaches it, the Add button stops working, and you need to suspend the study to raise the number. Oncology and long follow-up studies often pass 20 adverse events per subject.
What the site sees
The site selects Add New Measure, Event or Report. A window named Measure, Event or Report opens with your questions. Each saved entry becomes a row, and the site switches between Table view and List view to read them. Entries get a number in order of creation, which serves as the AE number.
When Enable GCP is on for the study, deleting an entry asks the site for a reason, and the audit trail keeps it.
What the export contains
By default each question produces one column per entry: AETERM_1, AETERM_2, and so on. For a listing with one row per event, tick RM in a separate sheet in the export window.
Build a fixed grid with Table/Matrix
š ļø Step by step guide
Open the form, click Add question and select Table/Matrix
Under Columns labels, select Add column for each data point and choose its type: Text input, Number value, Date/time or Dropdown
Under Rows labels, select Add row for each line, for example "Pre-dose", "30 min", "1 h", "2 h"
Select Save
A table holds up to 20 columns and 20 rows. The export gives one column per cell, named after the variable and the row title.
Limits to know
Calculations, File upload and Slider questions are not available inside a repeated measure.
A Table/Matrix cell accepts four types: text, number, date/time and dropdown.
Role-Based Edit and Role-Based Visibility work on questions inside a repeated measure.