What's new?

Module

Feature

Application Structure

• New topic describes how to restrict file system access.

BDL

• Updated topic on formatting CSV files for import.

BV

• A new section has been added describing the Batch Validation (BV) module.

Configuration Settings

• Help on the 'du_suec' setting has been removed as this setting is no longer in use.

DE/DR

• Information added to explain the use of print codes when printing a data clarification form for a DCR
• Information added to show which permissions are required to use the toolbar icons

DV

QM

• Information added to explain the display format of partial dates in Data View tables and Query module export files.

QM

• Information added to explain the use of real number questions instead of integer number questions to avoid errors when using the Query module.

REP

• Help on this module has been moved from within 'Using the DE/DR Module' to a new 'Using the Report Management module' book within the 'Designing Studies' Section.
• Information added on the new reports user.

SD

• A new topic has been added giving tips on designing a study to maximise performance
• Information added on the importance of using cycle specifiers in Arezzo expressions
• Information added on why category values should not be changed in a live study
• New topic gives an overview of 'Reasons For Change' (RFCs)
• Information added clarifying the difference between real number decimal formats when creating a question and when entering data.

SDDU

• Section rewritten to include the new Study Upgrade Expression Checker.

SM

The following role functions have been added:

• Access Reports Module

• Add Image to eForm

• Create Custom Reports

• Create Home Page Item

Module

Feature

All

The Data Management (DM) module is now referred to throughout the help as the Data Entry/Review (DE/DR) module.

All

Information on which user permissions are required for a task has been added to all relevant topics.

BDL

XML files can now be used to import data into MACRO via the Batch Data Loading module.

CC

All help for the Clinical Coding module is now located within the 'Entering and Reviewing Data' section.

CC

A new topic has been added giving information on batch coding thesaurus questions.

DBUU

A new topic has been added introducing the new Database Upgrade Utility (DBUU) which is used to upgrade a database from MACRO v3 to MACRO v4.

DE/DR

Information has been added to the Standard reports topic explaining that certain questions must exist in the study definition for the Adverse Events and Subject Details reports to work correctly.

DE/DR

The section on searching for data has been rewritten.

DE/DR

Information on unfreezing a visit date eForm has been added to the Freezing and Unfreezing data topic.

DE/DR

Information on the 'Printed' DCR status has been removed as this feature has been temporarily suspended.

SD

A new topic has been added giving information on printing eForms.

SD

Information on validating visit dates has been added to the Visit dates topic.

SD

Information on the CDASH eForm library has been added to the Copying items from another study topic.

SDDU

A new section has been added introducing the new Study Data Diagnostic Utility (SDDU) which is used to identify any corrupted subject data and to run a report listing all existing validations in a study definition.

SM

More information has been added explaining how study status affects what you can do in a study.

SM

A warning has been added explaining that if you choose to overwrite existing subject data during a subject data import, that existing data will be permanently removed.

SM

The list of role functions has been updated.

Module

Feature

DM

The section on coding clinically significant questions has been rewritten. It now includes batch coding.

DM

The topic on searching for response data now includes the new freeze/lock options.

DM

The topic on the audit trail now includes information about Reasons For Change.

DM

The section on setting up the home page has been rewritten.

DM

The topic Freezing and unfreezing data now includes information about how to unfreeze a visit date eForm in the Unfreezing an eForm section.

DM

The topics on using the search panel and browsers have been rewritten.

SM

A topic has been added on transferring a subject to a different site.

SM

The topic About databases now contains a warning about not copying MACRO databases.

SD

The maximum size of a text question has been updated in the Editing a question definition topic and throughout the help files.

SD

The topic on Changing an open study now advises users not to change or delete category value codes within a category question definition.

Module

Feature

Welcome

Links to the community website and the MACRO blog have been added to the Technical Support topic.

Admin

A new topic on backing up study data has been added.

DV

The section on the Data Views module has been updated.

DM

The topic on revalidating subjects has been updated.

SD, DM

The Not Applicable icon has been updated.

DM

A new section on randomisation has been added.

Module

Feature

API

A new topic introduces the MACRO API (Application Programming Interface).

DV

Triggers are no longer used in the Data Views module.

DM

A 'Maximum Records' field has been added to the Tools>Options section of the Data Management module. This is used to specify the maximum number of records that can be retrieved for features such as the Subject List and data browsers where multiple pages are used. The default number of records is 1000. If you perform a search that results in more than the maximum number of records, you will be asked to narrow down the search.

DM

A number of status buttons have been added to the toolbar. They act as shortcuts to listings of all subject data in the study with a particular status. Clicking one of the buttons displays a report, showing all items in the study with the relevant status. The buttons available are: Missing, Planned SDVS, Queried SDVs, Raised DCRs, Responded DCRs.