Permissions

Role function

Module

Scope

Enables the user to:

Access Archive

AR

Log in to the Archive module.

Access Auto Import

AI

Log in to the Auto Import module.

Access Batch Data Loading

BD

Log in to the Batch Data Loading module.

Access Batch Validation

BV

Log in to the Batch Validation module.

Access Clinical Coding Management

CC

Log in to the Clinical Coding module.

Access Create Data Views

DV

Log in to the Data Views module.

Access Data Entry

DE/DR

Log in to the Data Entry/Review module. 'Access Data Review' also currently exists but users only need one of these permissions in order to access the DE/DR module.

Access Data Reporter

DE/DR

Access the Data Reporter. The toolbar icon will be hidden from users without this permission.

Access Data Review

DE/DR

Log in to the Data Entry/Review module. Users do not also need Access Data Entry. 'Access Data Entry' also currently exists but users only need one of these permissions in order to access the DE/DR module.

Access Event Management

EM

Log into the Event Management module.

Access Library Management

LM

Log in to the Library Management module.

Access Query Module

QM

Log in to the Query module.

Access Remote Data Transfer

DT

Log in to the Data Transfer module.

Access Reports Module

REP

Log in to the Report Management module.

Access Study Data Diagnostic Utility

SDDU

Log in to the Study Data Diagnostic Utility.

Access Study Definition

SD

Log in to the Study Definition module.

Access System Management

SM

• Log in to the System Management module

• Log in to the Study Data Diagnostic Utility module

• Log in to the Report Management module

• Log in to the Event Management module

Add eForm to visit

SD

Add an eForm to a visit from the schedule.

Add image to eForm

SD

Add an image to an eForm.

Add site to study or study to site

SM

Database

Create an association between a site and a study. We recommend that if you assign this permission to a user role, you also assign the 'Remove site from study' permission so that a user can reverse the action if necessary.

Add subject to subject group

API

Manually add a subject to a static subject group.

Administer password policy

SM

Change the password policy.

Amend AREZZO

SD

Use the Arezzo Composer to create scheduling restraints for a study.

Assign user role to subject group

API

Assign or remove a user role for a subject group.

Attach reference document

SD

Attach a reference document to a study.

Auto encode

DE/DR

Batch code thesaurus questions.

Change clinical status

DE/DR

Change the coding status of a thesaurus question.

Change data

DE/DR

• Enter and change subject data

• Overruling a warning

• Adding/deleting a comment

• Manually change question status

• Revalidate multiple subjects

• Change DCR status

• Change SDV status

Change database password

SM

Change a database password.

Change date display

Not used in this version.

Change study status

SM

Database

Change the status of a study.

Change user access rights

SM

Database

Assign an existing user role to an individual user for specific studies/sites via the User Roles option. This does not allow you to change the user role itself.

Clear all data on eForm

DE/DR

Remove all enterable responses from the current eForm.

Close a DCR

DE/DR

Close a DCR from the DCR Browser.

Code clinical response

DE/DR

Code a thesaurus question using the associated MedDRA dictionary.

Configure Remote Data Transfer

DT

Database

Edit data transfer configuration settings.

Copy question from library study

SD

Copy a question from the library into the current study.

Copy question from other study

SD

Copy a question from another study into the current study.

Create a note

DE/DR

Attach a note to a question.

Create Custom Report

REP

Create a custom report.

Create database

SM

Create a new master database.

Create DCR

DE/DR

Raise a DCR for a question.

Create eForm

SD

Create a new eForm in a study.

Create Home Page Item

REP

Create items to display on the home page.

Create private search

DE/DR

Not used in this version.

Create public search

DE/DR

Save a public Data Reporter search that is shared with all users.

Create question

SD

Create or duplicate a question.

Create response comments

DE/DR

Attach a comment to a question.

Create SDV at eForm level

DE/DR

Attach a SDV mark to an eForm.

Create SDV at question level

DE/DR

Attach a SDV mark to a question.

Create SDV at subject level

DE/DR

Attach a SDV mark to a subject.

Create SDV at visit level

DE/DR

Attach a SDV mark to a visit.

Create security database

SM

Create a new security database.

Create site

SM

Database

Create a new site.

Create site level search

DE/DR

Not used in this version.

Create study

SD

Create a new study.

Create subject

DE/DR

Create a new subject. You also need the View data permission.

Create subject group

API

Create a new subject group.

Create subject group level search

DE/DR

Not used in this version.

Create user

SM

Create a new user. You also need the Edit User permission.

Create visit

SD

Create a new visit in a study.

Delete eForm

SD

Delete an eForm from a study.

Delete private search

DE/DR

Not used in this version.

Delete public search

DE/DR

Delete a public Data Reporter search.

Delete question

SD

Delete a question, comment, image or line from a study.

Delete site level search

DE/DR

Not used in this version.

Delete study

SD

Delete a study.

Delete subject group level search

DE/DR

Not used in this version.

Delete visit

SD

Delete a visit from a study.

Distribute laboratory

SM

Database

Distribute a laboratory definition to a remote site

Distribute new version of study definition

SM

Database

Distribute or recall a study definition to/from a remote site

Edit private search

DE/DR

Not used in this version.

Edit public search

DE/DR

Not used in this version.

Edit question groups

SD

Edit an existing question group.

Edit question metadata description

SD

Edit the metadata description for a question in the question definition window.

Edit site

SM

Database

Edit a site.

Edit site level search

DE/DR

Not used in this version.

Edit study details

SD

Database

Edit the study details.

Edit subject group

API

Edit a subject group description, condition or type and activate/deactivate a subject group.

Edit subject group level search

DE/DR

Not used in this version.

Edit user

SM

Edit user details.

Export laboratory

SM

Database

Export a laboratory definition for import into another study.

Export study definition

SM

Database

Export a study definition for import into another study.

Export subject data

SM

Database

Export subject data to be imported into another study.

Freeze at eForm level

DE/DR

Freeze an eForm. You also need 'Monitor/review data' permission.

Freeze at question level

DE/DR

Freeze a question. You also need 'Monitor/review data' permission.

Freeze at subject level

DE/DR

Freeze a subject. You also need 'Monitor/review data' permission.

Freeze at visit level

DE/DR

Freeze a visit. You also need 'Monitor/review data' permission.

Import clinical thesaurus

CC

Register a MedDRA dictionary to be used with thesaurus questions.

Import laboratory

SM

Database

Import a laboratory definition from another database.

Import study definition

SM

Database

Import a study definition from another database.

Import subject data

SM

Database

Import subject data from another database.

Laboratory/site administration

SM

Database

Associate laboratories with sites.

Lock at eForm level

DE/DR

Lock an eForm. You also need 'Monitor/review data' permission.

Lock at question level

DE/DR

Lock a question. You also need 'Monitor/review data' permission.

Lock at subject level

DE/DR

Lock a subject. You also need 'Monitor/review data' permission.

Lock at visit level

DE/DR

Lock a visit. You also need 'Monitor/review data' permission.

Maintain clinical tests

LM

Create, edit and delete tests and test groups.

Maintain common toxicity criteria

LM

Create, edit and delete common toxicity criteria for CTC schemes.

Maintain CTC schemes

LM

Create, edit and delete common toxicity criteria schemes.

Maintain eForm

SD

Edit an eForm definition.

Maintain laboratories

LM

Create, edit and delete laboratories.

Maintain normal ranges

LM

Create, edit and delete normal ranges for laboratories.

Maintain question

SD

Edit a question definition.

Maintain registration

SD

Set up subject registration.

Maintain schedule

SD

Place single and repeating eForms in a visit, and manage eForm access rules.

Maintain user role

SM

Edit the role functions contained within a user role.

Maintain visit

SD

Edit a visit title in the schedule

Edit a visit date or label in the schedule

Change the background colour of a visit

Monitor/review data

DE/DR

Search for subjects in the Data Browser

See the 'Inform' question status icon when a question activates a 'Flag if' condition

Overrule warnings

DE/DR

Overrule a validation warning.

Register database

SM

Register an existing database.

Register subject

DE/DR

Register a subject when prompted.

Remove all locks

SM

Removes all existing locks from the selected database. Note that failing to close a subject or study before removing all locks can corrupt data so this permission should only be given to users who fully understand how to use it. The 'Remove own locks' permission is a safer option.

Remove eForm from visit

SD

Remove an eForm from a visit.

Remove own locks

SM

Removes all own existing locks from the selected database.

Remove reference document

SD

Remove a reference document from a study.

Remove site from study

SM

Disassociate a site from a study. We recommend that if you assign this permission to a user role, you also assign the 'Add site to study' permission so that a user can reverse the action if necessary.

Reset password

SM

Reset another user's password.

Restore database

Not used in this version.

Set security database

SM

Change the security database to be used in the next session.

Transfer subject

SM

Transfer an existing subject to a different site.

Unfreeze at eForm level

DE/DR

Unfreeze an eForm. You also need 'Monitor/review data' permission.

Unfreeze at question level

DE/DR

Unfreeze a question. You also need 'Monitor/review data' permission

Unfreeze at subject level

DE/DR

Unfreeze a subject. You also need 'Monitor/review data' permission

Unfreeze at visit level

DE/DR

Unfreeze a visit. You also need 'Monitor/review data' permission

Unlock at eForm level

DE/DR

Unlock an eForm. You also need 'Monitor/review data' permission.

Unlock at question level

DE/DR

Unlock a question. You also need 'Monitor/review data' permission.

Unlock at subject level

DE/DR

Unlock a subject. You also need 'Monitor/review data' permission.

Unlock at visit level

DE/DR

Unlock a visit. You also need 'Monitor/review data' permission.

Unregister database

SM

Unregister a database.

Validate clinical code

DE/DR

Change the coding status of a thesaurus question to Validated.

View data

DE/DR

• Open the search panel

• Open the subject list

• Open the schedule for a subject

• Create a new subject

• Print eForms or browser reports

View DCR

DE/DR

View DCRs from the Search panel, the toolbar buttons or from an eForm.

View lock/freeze history

DE/DR

View the Lock/Freeze History Browser via the Search panel.

View notes

DE/DR

View notes via the Search panel or from an eForm.

View question audit trail

DE/DR

View the audit trail for a single question from an eForm.

View response comments

DE/DR

View comments in the Question Properties pod from an eForm.

View SDV mark

DE/DR

View SDV marks from the Search panel, the toolbar buttons or from an eForm.

View system log

SM

View a log of system actions.

View user log

SM

View the user log file.