Standard CDMS Security Profiles
In Vault, each user has an assigned license type and security profile. Each security profile has one or more permission sets. The license type, either Full User or Read-only User is the first level of access control that vault applies to a user. Permission sets, applied through the user’s security profile, are the second level of access control. Both the license type and permission set must grant access to a user in order for that user to access the functionality.
Security profiles are how Vault applies permission sets to individual users. Each profile has one or more associated permission sets.
Standard Security Profiles with Multi-role Security
21R2 & Later
With the Multi-Role Security feature, all users have one security profile.
Contact Veeva Support to enable Multi-Role Security in your vault.
| Security Profile | Permission Sets | Description | Study Roles |
|---|---|---|---|
| CDMS All Access |
|
This security profile, for use with multi-role security, is assigned to all users. User access is then controlled by Study Role. | All |
Standard Security Profiles with Role by Study
19R1 & Later
Vault CDMS includes several security profiles that are added with the enablement of Roles by Study. You can click down into each of these security profiles from within Admin > Users & Groups > Security Profiles to view which permissions are associated with each security profile.
Contact Veeva Support to enable CDMS Role by Study in your vault.
EDC Security Profiles
| Security Profile | Permission Sets | Description | Study Roles |
|---|---|---|---|
| CDMS Auditor Read Only |
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This security profile is intended for use by read-only users, such as auditors. This security profile grants read-only access to the Data Entry tab. | CDMS Auditor Read Only |
| CDMS Clinical Coder Manager |
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This security profile grants access to the Coder tab, for the purpose of approving code requests. This security profile also grants the ability to view reports and dashboards. | |
| CDMS Clinical Assessment Editor |
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This security profile grants access to the Assessments tab for the purpose of performing clinical assessments. | CDMS Clinical Assessment Editor |
| CDMS Clinical Assessment Reader |
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This security profile grants access to the Assessments tab for the purpose of viewing completed clinical assessments. | CDMS Clinical Assessment Reader |
| CDMS Clinical Research Associate |
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This security profile grants access to the Review, Reports, and Dashboards tabs for the purpose of running jobs, viewing reports and dashboards, viewing study execution data, and performing various other review tasks. | CDMS Clinical Research Associate |
| CDMS Clinical Research Coordinator |
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This security profile grants access to the Data Entry tab for the purpose of entering study execution data, and answering queries. | CDMS Clinical Research Coordinator |
| CDMS Data Manager |
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This security profile grants access to the Review, Reports, and Dashboards tabs for the purpose of running jobs, viewing reports and dashboards, viewing study execution data, and performing various other data management tasks. | CDMS Data Manager |
| CDMS Deployment Administrator |
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This security profile is intended for use by the deployment administrator. This security profile grants access to all objects and application areas required for managing automated deployments. | CDMS Deployment Administrator |
| CDMS Lab Data Manager |
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This security profile grants access to the Labs tab for configuration of analytes and lab data management. | CDMS Labs Data Manager |
| CDMS Lead Data Manager |
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This security profile grants access to EDC Tools and the Review tab, to run and schedule jobs, view reports and dashboards, view study execution data, and to perform various other study administration and data management tasks. | CDMS Lead Data Manager |
| CDMS Librarian |
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This security profile grants access to the Library tab with the ability to create and edit design objects for a library collection and test the study design in the relevant application areas. | CDMS Librarian |
| CDMS Principal Investigator |
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This security profile grants access to the Data Entry tab for the purpose of entering study execution data, answering queries, and providing signatures. | CDMS Principal Investigator |
| CDMS Sub Investigator |
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This security profile grants access to the Data Entry tab for the purpose of entering study execution data, and answering queries. | CDMS Sub Investigator |
| CDMS Study Designer |
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This security profile grants access to EDC Studio with the ability to create and edit design objects, view reports and dashboards, initiate jobs from within Studio, and access the Vault CDMS API. | CDMS Study Designer |
| CDMS Study Designer Read Only |
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This security profile grants read-only access to the Studio area. | CDMS Study Designer Read Only |
| CDMS User Administrator |
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This security profile is intended for use by dedicated user administrators, for the purpose of managing user accounts and study access only. This security profile grants total access to Vault CDMS. | CDMS User Administrator |
| Data Entry |
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This security profile grants access to the Data Entry tab for the purpose of entering study execution data, answering queries, and providing signatures. |
This security profile is no longer mapped by default to any standard roles. Previously, it was mapped to:
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| CDMS Super User |
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This security profile grants access to all areas of Vault CDMS. | CDMS Super User |
| CDMS API Read Only |
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This security profile grants access the access required to use the CDMS API for read-only purposes. | CDMS API Read Only |
| CDMS API Read Write |
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This security profile grants access the access required to use the CDMS API for read and write purposes. | CDMS API Read Write |
| Vault Owner |
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In addition to the Vault platform Vault Owner permissions, Vault Owners in CDMS can perform any and all tasks available in Vault CDMS. This security profile can also access the Vault Admin area. | N/A |
Coder Security Profiles
| Security Profile | Permission Sets | Description | Study Roles |
|---|---|---|---|
| CDMS Clinical Coder |
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This security profile grants access to the Coder tab, for the purpose of assigning codes, creating queries, and creating notes. This security profile also grants the ability to view reports and dashboards. | CDMS Clinical Coder |
| CDMS Clinical Coder Administrator |
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This security profile grants access to the Coder and Coder Tools tabs, with the purpose of managing the Coder application and its settings. This security profile also grants the ability to view reports and dashboards. In the current release, users with this security profile are unable to access jobs, even with those permission sets, because this profile does not grant access to the EDC Tools area. | CDMS Clinical Coder Administrator |
| CDMS Deployment Administrator |
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This security profile is intended for use by the deployment administrator. This security profile grants access to all objects and application areas required for managing automated deployments. | CDMS Deployment Administrator |
| CDMS User Administrator |
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This security profile is intended for use by dedicated user administrators, for the purpose of managing user accounts and study access only. This security profile grants total access to Vault CDMS. | CDMS User Administrator |
| CDMS Super User |
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This security profile grants access to all areas of Vault CDMS. | CDMS Super User |
| CDMS API Read Only |
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This security profile grants access the access required to use the CDMS API for read-only purposes. | CDMS API Read Only |
| CDMS API Read Write |
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This security profile grants access the access required to use the CDMS API for read and write purposes. | CDMS API Read Write |
| Vault Owner |
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In addition to the Vault platform Vault Owner permissions, Vault Owners in CDMS can perform any and all tasks available in Vault CDMS. This security profile can also access the Vault Admin area. | N/A |
There are several other standard security profiles available in your vault as part of the Vault Platform. We recommend that you only use the security profiles listed here or custom security profiles, as the other standard profiles may not have functional access to CDMS application functionality.
In some cases, you may want to create custom Security Profiles. For example, to create a profile that allows a user to access the Data Entry area, but not view the Reports tab. You can create a custom security profile and assign standard Permission Sets to it.
Standard Security Profiles without Role by Study
Prior to 19R1
Vault CDMS includes several standard security profiles:
Known Issue:
In the current release, users with the EDC Lead Data Manager and EDC Data Manager security profiles have access to the Vault Business Admin area by default.
To remove this access, create a new security profile without the Study Jobs permission set, and assign it to your data manager users.
EDC Security Profiles
| Security Profile | Permission Sets | Description | Study Roles |
|---|---|---|---|
| EDC CRA |
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This profile grants limited access to manage data. This profile provides the ability to perform SDV, close queries, freeze data, access reports, and create PDFs. | EDC CRA |
| EDC Clinical Research Coordinator |
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This profile grants full access to the data entry area. This profile provides the ability to answer queries, submit forms, and create blank PDFs. | EDC Clinical Research Coordinator |
| EDC Data Manager |
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This profile grants full access to manage data. This profile provides the ability to perform data management review, view DMR, create PDFs, access reports, and lock data. | EDC Data Manager |
| EDC Deployment Administrator |
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This security profile is intended for use by the deployment administrator. This security profile grants access to all objects and application areas required for managing automated deployments. | EDC Deployment Administrator |
| EDC Investigator |
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This profile grants full access to the data entry area. This profile provides the ability to answer queries, submit forms, access reports, provide an eSignature, and create PDFs. | EDC Investigator |
| EDC Lead CRA |
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This profile grants limited access to manage data. This profile provides the ability to perform SDV, close queries, freeze data, access reports, and create PDFs. | EDC Lead CRA |
| EDC Lead Data Manager |
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This profile grants full access to manage data. This profile provides the ability to perform data management review, view DMR, create PDFs, access reports, and lock data. This profile also has access to the EDC Tools area by default. | EDC Lead Data Manager |
| EDC Reviewer |
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This grants read-only access. This security profile provides the ability to create a PDF. | EDC Reviewer |
| Vault Owner |
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In addition to the Vault platform Vault Owner permissions, Vault Owners in CDMS can perform any and all tasks available in Vault CDMS. This security profile can also access the Vault Admin area. | N/A |
Coder Security Profiles
| Security Profile | Permission Sets | Description | Study Roles |
|---|---|---|---|
| EDC Clinical Coder |
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This profile provides the ability to view the Coder tab, code, and to send, receive, respond, and close queries. | EDC Clinical Coder |
| EDC Clinical Coder Administrator |
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This profile allows for managing upversioning and managing and assigning of synonym lists and stop lists. Coder Administrators can also set up and modify application and study settings. | EDC Clinical Coder Administrator |
| EDC Deployment Administrator |
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This security profile is intended for use by the deployment administrator. This security profile grants access to all objects and application areas required for managing automated deployments. | EDC Deployment Administrator |
| Vault Owner |
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In addition to the Vault platform Vault Owner permissions, Vault Owners in CDMS can perform any and all tasks available in Vault CDMS. This security profile can also access the Vault Admin area. | N/A |