A MACRO study definition consists of data in the MACRO database tables and an associated Arezzo definition (the CLM file).
A MACRO subject consists of data in the MACRO database tables and associated data in Arezzo tables.
Every response value entered during data entry is recorded in the MACRO database, but is not stored in Arezzo.
Every visit instance and eForm instance in the subject schedule is stored in the MACRO database and also as task instances in Arezzo.
Inactive visit and eForm instances (i.e. those appearing as grey on the subject schedule) are not stored in either the MACRO database or in Arezzo.
Study Definition Item |
MACRO Database Table |
Arezzo |
Study definition |
CLINICALTRIAL |
CLM file |
Visit definition |
STUDYVISIT |
Plan task in CLM file |
eForm definition |
CRFPAGE |
Plan task and action task in CLM file |
Question definition |
DATAITEM |
Data item in CLM file |
eForm in schedule |
STUDYVISITCRFPAGE |
Plan component in CLM file |
Question on eForm |
CRFELEMENT |
Not stored |
Subject Data Item |
||
Subject |
TRIALSUBJECT |
GuidelineInstance table |
Active visit instance |
VISITINSTANCE |
TaskInstance table |
Active eForm instance |
CRFPAGEINSTANCE |
TaskInstance table (2 task rows) |
Response value |
DATAITEMRESPONSE |
Not stored |
Inactive Visit instance |
Not stored |
Not stored |
Inactive eForm instance |
Not stored |
Not stored |
Arezzo data is stored differently in MACRO v3 and v4:
There is no binary "psf" (Patient State File) as in MACRO v3. Instead, data is stored in Arezzo tables within the main MACRO database.
The PROFORMASTATE field no longer exists in the TRIALSUBJECT table. The new AREZZOKEY field in the TRIALSUBJECT table contains the unique identifier linking to the Arezzo GuidelineInstance and other tables.
Response data is not stored in Arezzo.
Dormant tasks (i.e. those seen as grey on the subject schedule) are not stored in Arezzo.