What's new?

Module

Feature

API

• Added help for the new REST API calls to create a new user and to request subject data.
• Added help for the Web API call to create a user
• Updated help for Web API calls to request subject data

AR

• Updated screenshot to show that PDF output now contains a link back to the current data from the audit trail section.
• Added a note that files attached to multimedia questions cannot be viewed from the PDF output.
• Updated help on the output options.

CC

• Added help on the new recoding tool.
• Added a note on a known issue that occurs when changing a question type from text to thesaurus.

SD

• Improved help on the use of the calendar button for date/time questions.
• Added help to explain that the current time is saved for date/time questions.
• Updated the supported separators for date/time questions.
• Added help to say that inform messages cannot be overruled.
• Updated help to explain that the display length can be set in the eForm definition window for thesaurus questions as well as text questions.

SM

• Improved help on the overwrite options given when importing a study.

Web DE/DR

• Added help on how to add a partial date using the calendar button.
• Data Reporter:

o     Added help on change to frequency report layout.

o     Added help on text change to 'subject ID' in the Columns panel.

o     Updated screenshots to show text change in Data Filter panel from 'N/A' to 'Not Applicable.'

o     Added help on change to SPSS variable types when downloading columnar report results.

o     Added help on how to choose the columns to include in a columnar report when it exceeds the maximum no of records.

o     Added help on selecting the study when loading a saved search.

o     Added help on the characters that cannot be used in a search name.

o     Added help on setting the expiry period for a search result.

Module

Feature

CC

• Added help on the new recoding tool.

Web DE/DR

• Added a recommendation for the 'Number of records per page' setting in the Environment section of the Administrator options.
• Updated help on the toolbar shortcut buttons for missing data, SDVs and DCRs as they no longer display a count of records when you hover over them.

Module

Feature

Admin

• Added help on two new configuration settings which enable you to customise the Data Reporter search queue expiry period in the Web DE/DR module.

Web DE/DR

• Added help on new step to select a question when viewing a frequency report.
• Updated help on the updated frequency report.
• Added help on how to remove a filter when viewing a columnar report.

Module

Feature

• Removed all references to Oracle databases as they are no longer supported

Admin

• Added help on seven new configuration settings which enable you to set behaviour for the new Data Reporter tool.
• Added help on three new configuration settings which enable you to set up custom toolbar buttons in the Web DE/DR module.

API

• Added help on creating a new subject
• Added help on the new option to set the status of a blank response to Missing or Not Available
• Added help on managing Data Reporter searches
• Updated help on setting timestamps and time zones when entering data
• Updated list of country codes

CL

• Added help on the new Command Line call to import question responses from a file
• Added help on the Command Line call to create a new subject

DT

• Added help on the File Transfer Address option in the configuration settings

REP

• Clarified target locations for standard reports
• Updated help to include linking to SSRS custom reports.

SM

• Added help on the new permissions for the Data Reporter: Access Data Reporter, Create public search, Delete public search.
• Added help on the new option to request all subject data from a remote site.
• Added help on the new Data Transfer error log.
• Added help on the new option to copy a subject group.

Web API

• Created new section to provide help on the Web API

Web DE/DR

• Added help on the new Data Reporter tool.
• Added help on the new custom tool bar buttons.
• Updated help to include the current eForm being highlighted in the QuickView schedule.

Module

Feature

RDT

• Added more information to the remote data transfer introduction

RDT

• Simplified the overview of the transfer process

RDT

• Simplified the overview of the import process

SM

• Added help on restoring a remote site database

Web DE/DR

• Added help on the custom homepage check option

Module

Feature

Administration

• Added a list of task types that are logged in the performance log table

CL

• Added help on entering subject data via the Command Line module

LM

• Added help on creating units of measurement
• Added the requirement to associate a laboratory with a site

SD

• Added a list of Arezzo functions and operators in alphabetic order

• Added an explanation of using 'else' in a 'case' expression

• Added an explanation of using 'isknown' with '&' when concatenating text strings

• Added some examples for Arezzo Set Functions

• Created a new overview topic to explain subject registration

• Added info on registration to list of changes you cannot make to a live study

• Added help on how to create visit labels

• Improved help on how to create eForm labels

• Added help on dynamic sorting for category options

SM

• Added new permission to clear all data on an eForm

• Added info on System and User logs being limited to displaying the most recent 10,000 records.

Web DE/DR

• Added the search panel Subject Group field to the help on viewing a question audit trail

• Added info on labels and dates for visits and eForms

• Added help on clearing all responses from an eForm

• Added help on opening the last opened eForm for a subject from the Recent Subject List

Module

Feature

Administration

• Added help for logperformance config setting to enable the logging of performance statistics.

• Added help for HomepageLogo config setting to set the image displayed at the top of the standard home page.

• Added help for CompanyLogo config setting to set the image displayed at the top of standard reports.

API

• Updated CreateDcr call to include returning the unique DCR ID for the newly created DCR.

• Added help for new EditDcr call to edit status and/or DCR text.

• Added help for the new subject group calls.

• Added help for the new eForm access rule calls.

CL

• Updated CreateDcr call to include returning the unique DCR ID for the newly created DCR.

• Added help for new EditDcr call to edit status and/or DCR text.

• Added help for the new subject group calls.

• added help for the new eForm access rule calls.

EM

• Added help for new event action type which allows you to trigger a set of Command Line calls.

• Added note to explain checks provided by the Expression Editor when defining an event

REP

• Added help for the new Annotated CRF report

SD

• Added help for the new Annotated CRF report

• Added help for new dynamic hotlinks

• Added a new topic to explain how to create links from eForms to attached study files.

• Added a new topic to explain the concept of role-based eForm access.

• Added a new topic to explain how to manage eForm access rules.

• Added help for the new option to share option lists between category questions.

• Changed topic name from 'Category codes and values' to 'Managing category options'.

• Added explanation about validation warning messages not displaying for derived questions.

• Added explanation that question validations are not run on empty questions.

• Changed topic name from 'Changing an open study' to 'Updating a live study'.

• Added the recommendation for users to perform their own risk and impact assessment when updating a live study.

• Added the recommendation to use Source Data Verification to reduce the risk of data entry users bypassing question validation.

• Added steps to set up randomisation using a combination of Arezzo and the registration feature.

• Added a note to explain the difference between the standard Expression Editor and the one used to define events and subject groups.

SM

• Added explanation about deactivated users seeing a message to explain why they cannot log in to MACRO.

• New section to explain the new subject group feature.

• Added 4 new user role functions for subject groups; Add subject to subject group, Assign user role to subject group, Create subject group, Edit subject group.

Web DE/DR

• Added help on how to return to original subject after clicking dynamic hotlink to another subject

• Added a new topic to explain how to view attached study files from an eForm.

• Added help explaining the possible effect of the new role-based eForm access.

• Added help for new option to display validation warning messages for derived questions.

• Added help for new Subject List drop down options to filter subjects by study and site.

• Added help for new Recent Subjects List.

• Added help for new option for Web DE/DR users to change their own email address.

• Added help for new option to configure drop down lists to automatically expand when the question is selected.

• Added help for new auto complete category question feature.

• Added help for new question search feature.

• Updated help for search panel to include the new Subject Group dropdown list.

• Updated help to explain how to change the status for multiple DCRs in one action from the DCR browser.

• Update help to explain how to change the status for multiple SDVs in one action from the SDV browser.

Welcome

• Corrected the customer support email address and link.

Module

Feature

Administration

• Added the configuration settings required to switch on/off remote data transfer and to set the Auto Import log file location.

API

• Added information on setting up the API in a location other than the MACRO installation folder.

CC

• Added help on new Clinical Coding Export report.

RDT

• Clarified that remote data transfer is only validated on SQL Server and not Oracle databases.
• Updated the steps required to view the DOS name for directories.

SD

• Clarified that you cannot remove questions from question groups in an open study.

• Clarified that you cannot edit or delete an existing category option in an open study.

Web DE/DR

• Corrected the permissions required to receive, respond to, re-raise, close and edit DCRs.
• Corrected the permissions required to edit an SDV.

Module

Feature

RDT

• User detail changes are now synchronised between the server and remote site.

• New help on log file generation when importing data via the Command Line.

• New explanation of the availability of transferred DCRs, SDVs and notes.

Module

Feature

• The look and feel throughout the help has been updated to be consistent with Elsevier branding

• Technical support and User Community website links have been updated

• The help table of contents has been reordered to make it quicker to find help for each module

API

• New help on the API  including reference information for all new routines. This help replaces the previously-available PDF guide.

CL

• New help on the Command Line module. This help replaces the previously-available PDF guide.

DBUU

• Help amended to explain the new procedure for upgrading a v3 database to a version newer than v4.5.0

DE/DR

• New help on editing and viewing text changes for DCRs, SDVs and notes

• Details of files attached to multimedia questions are now stored in the question audit trail

• New help on the difference between types of subject identifier

• New help on the option to display gridlines on the schedule.

• New help on the ability to delete saved searches in the search panel

SD

• The explanation of question validation has been improved

• Added help on including negative numbers in number question formats

• Amended help on the rules for changing new questions in an open study

• New help on how to specify the unit to be used when determining the display width of text boxes

SM

• Improved help on the characters allowed when entering user details

• Added the CDISC options to the help on importing laboratory definitions and study definitions

• Added help on unlocking a user

• Information on permission scope has been added to study and subject export topics

Module

Feature

AR

• Added help on unlocking the module

BD

• Added help on unlocking the module

BV

• Added help on unlocking the module

CC

• Added help on unlocking the module

CL

• Added help on the new Command Line (CL) module which enables you to make API calls

DE/DR

• Clarified the use of DCF batch numbers when searching for DCRs

• Updated help on printing data clarification forms

• Added help on editing preferences via configuration files

• Added note about visit names not being fixed at the top of the schedule when using Internet Explorer 7 or 8

• Added note about being logged in to the security database before editing the SMTP settings in the Administrator options

DT

• Added help on unlocking the module

DV

• Added help on unlocking the module

EM

• Added help on unlocking the module

LD

• Added help on unlocking the module

QM

• Added help on new Output Option 'Output as Unicode'

• Added help on opening CSV files containing Unicode data in Excel

• Integer responses longer than 10 digits are changed to decimal format in the output

• Added help on unlocking the module

• Added help on two new Output options for SAS output: 'Precede SAS informats with colons' and 'Limit SAS strings to 200 characters'

• Added information on exporting data containing Unicode characters

RDT

• Added list of limitations to the transfer process

REP

• Added help on unlocking the module

SD

• Clarified that if you are creating an Arezzo expression in which you refer to a question on the current eForm, you must use the question code only and not include the eForm and visit

• Added explanations of how the new empty cycles of repeating eForms and visits do not affect visit subject status

• Added note on importance of setting an eForm to be repeating on the visit schedule before setting the number of cycles

• Added help on displaying integers with leading zeroes in a text string such as a subject label

SDDU

• Added help on unlocking the module

Module

Feature

BD

• Help added on how to include a Not Available response in an individual response or a batch upload file

DE/DR

• The < character cannot be used in SMTP passwords

• DCR, SDV, Note and Comment status is now included in the row status icon for a repeating question group

• New explanations of the Print Code and Print Batch Number when printing a data clarification form

• Clarification of the two types of response timestamp

Remote Data Entry

• Help added on the two new modules, Data Transfer (DT) and Auto Import (AI) that together make up the remote data entry feature

SM

• Users are forced to change their passwords the first time they log in to any MACRO module and the next time they log in after another user has reset their password.

• Help added on distributing study and laboratory definitions to remote sites

• Help added on study version control

Module

Feature

AR

• New help on the automatic generation of XML data

DE/DR

• More help on the completion on non-cycling eForms within cycling visits

REP

• Added location of each standard report

• New help on the Detailed Study Definition standard metadata report

• New help on the ability to specify a default save location for custom reports

SD

• More help on the completion of eForms

SM

• New help on the need to recreate custom reports after changing a database password

Module

Feature

AR

• Handling of special characters in subject labels for PDF and HTML outputs

BDL

• eForm/visit dates must be completed when inputting individual responses

Configuration Settings

• A new key SortSubjectsBySubjectLabel enables you to order the Subject QuickView list by subject label instead of subject ID

DBUU

• The upgrading of existing MACRO v4 databases

DE/DR

• Links within the help system text now open in a new window to help you to keep your place when navigating through the information

• Saved searches are now being listed in alphabetical order

• New information on the date formats in the SPSS Export report

• Visit/eForm cycle numbers are now displayed on an eForm

• How to add line breaks when answering a text question

• The Question Information window and the question tooltip now indicate if a question is optional or mandatory

• New ability to list sites by code instead of name when creating a new subject

• Pressing F7 to save an eForm now updates any derivations and validations on the eForm

LD

• New help section describing how to use the new, optional Language Definition module

QM

• Clinical coding information added to list of question attributes

SD

• 'Editing, deletion and removal of newly created questions' added to the list of changes you can make to an open study

• Adding eForms to the schedule can now only be done using the right click popup menu

• New information explaining the algorithm used for rounding numbers in Arezzo expressions

SM

• DCRs, SDVs, notes and freeze/lock messages are now always exported with subject data

• Database version is checked against product version at login

Module

Feature

API

• The list of actions has been updated to reflect the latest API functionality.

BV

• Warning added not to run BV from the Command Line simultaneously for two or more subjects.

Configuration Settings

• New information on the DataBrowserHighPerformanceMode setting.

• New information on changing the system timeout period for the Web DE module.

• Topics renamed

DE/DR

• New topic on using High Performance Mode to speed up the retrieval of results in a data browser search.

• New topic on monitoring events

EM

• New information on setting up email alerts for events

• New topic on viewing triggered events

• New topic on re-running failed event actions from the Command Line

QM

• More information on representing missing values for full and partial date questions in QM output.

• More information on the 'Format' and 'Label' SAS output files.

REP

• More information on the new standard report SPSS Export

SD

• Added a number of MACRO terms

• New information on displaying information about authorisation questions

• New information on displaying CTC grades and normal range status

• New information on using partial dates with valid_date and read_date

• New information on the need to re-apply user roles after reinstating a deleted study

SM

• New information on the scope of user permissions.

• New explanation of the 'LogNo' column in the SM logs.

• New suggestion to assign the 'Add site to study' and 'Remove site from study' permissions as a pair.

• New information on exporting subject data in SPSS format.

• New information on new option 'User > View Disabled Users'.

• Updated information on saving a database creation script.

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.