All Climedo management rights and their explanation

Modified on Wed, 3 Sep at 5:50 PM

Learn which rights can be assigned per collaborator in Climedo (based on study package) and what they entail.

⭐ Management rights are defined at the level of the collaborator.

Access Management

Collaborators
View	The permission includes the ability to view all collaborators who have been added to the study, including their email addresses, names, roles, title, additional information (if any), status as main/guest user, collaborator status (including date of user created, updated and last login date), Management rights status.
Create	Authorization to invite and add further collaborators with the respective role and site affiliation to the study. While creating a collaborator the respective role(s), site(s) and management rights (per collaborator) are assigned. Please note that this requires view rights for collaborators, roles and sites.
Update	Allows to adjust things like role, site affiliation and management rights for other collaborators (and for themselves) within the study. Please note that this requires view rights for collaborators, roles and sites. Please note that the email address of a collaborator cannot be updated once they were added. Only the collaborator can update their first and last name.
Archive	Authorization to deactivate or even remove (delete) a collaborator. "deactivate" means that the collaborator .... "remove" means that the collaborator .... Please note that this requires view rights for collaborators, roles and sites.
Roles
View	Authorization to see the list of all created roles including the rights associated with these roles.
Create	Permission to add and create further roles. Please note that this requires the view right for roles.
Update	Allows to adjust available roles. Please note that this requires view right for roles. The "create" right is not per default included in the "update" right!
Archive	Authorization to delete roles. Please note that this requires view right for roles. Please note that roles assigned to an active collaborator (status = active) cannot be deleted!
Export	Permission to export all role configurations as an Excel file. Please note that this requires the view right for roles.
Sites
View	Authorization to see all sites with information such as site ID, site name, Country, and further additional information if used.
Create	Permission to add and create additional sites. Please note that this requires the view right for sites.
Update	Allows to update the site name, site ID and all additional information. Please note that a change of the site ID is no longer possible once the first patient has been enrolled at the respective site. Please note that this right requires the view right for sites.
Archive	Authorization to remove (delete) sites from the study. Please note that a deletion is no longer possible if there are collaborators who are associated with this study only (regardless of the collaborator status). Same applies if there is at least one subject enrolled at this site. Please note that this requires the view right for sites.
Labs
View	Allows a user to see all lab details, including uploaded reference lists. It is the baseline permission that underpins all other lab rights. Without View, no other actions in the lab module are possible.
Configure	Allows a user to set up and modify lab parameters and subject-specific variables. This right is dependent on View, meaning the user must be able to see lab details in order to configure them.
Create	Allows a user to add new labs within a study. It also includes the ability to upload the initial reference list for a lab. This right depends on View.
Update	Allows a user to change existing lab details, including uploading or replacing reference lists. As with all other actions, this right depends on View.
Archive	Allows a user to delete (archive) labs. This action is restricted to those with View rights, as users must be able to see a lab before they can archive it.
Export collaborators & rights	With this right, all collaborators (including login information, site association and collaborator details) and their associated roles and management rights can be exported in an Excel file. Please note that this requires the view rights for collaborators, roles and sites.

Input forms and fields

View	Allows the user to see the set up of all study forms in Step 3, but not to edit them.
Update	Gives permission to create new forms in Step 3 as well as to update existing or new forms as needed. "Updating" includes both the forms and the contained input fields. Please note that the authorization to view input forms and fields is required for this. Please note that some forms need to be enabled as premium feature (e.g. (S)AE)
Share as template with others	In our system there is the possibility to save a form as a template for the current study or for the whole instance to be available as form template in all studies. This function gives the respective collaborator the right to save input forms as templates. Please note that the authorization to view input forms and fields is required for this.
Export	Created input forms added to the study workflow (meaning: the entire set up of your study) can be exported as PDFs with different content.
Blank PDF	A blank PDF reflects the eCRF as it would look on paper. All forms with all input fields within all steps (visits) are contained in the PDF, regardless of any dependencies between them. Please note that the authorization to view input forms and fields is required for this.
Annotated PDF	The entire study structure is displayed in the annotated PDF. The export includes all information about the steps (visits), input forms and fields, such as display labels, export labels, validations, dependencies and much more. It is recommended that before (e.g. at the completion of an UAT) and after activating the study as well as after amendments, an annotated PDF is exported for your own records and documentation filing. Please note that the authorization to view input forms and fields is required for this.

Study Management

Study settings	With this permission, the collaborator can both view and edit the general study settings in Step 1.
Update data collection workflow	Allows the collaborator to edit the workflow (set up) of the study in Step 4, such as adding/removing steps and forms, creating and updating ePRO steps and settings, managing the (S)AE process setup etc. Please note that the authorization to view input forms and fields is required for this. Please note that some workflows need to be enabled as premium feature (e.g. (S)AE)
Update trigger events	With this right you can create and edit Validations, Automated Queries, Notifications and Mirrored Fields in Step 5. Please note that the authorization to view input forms and fields is required for this.
Duplicate/Activate study	This function provides a collaborator with the right to duplicate and/or activate this study. Please note that the right to create and delete a study is managed on the level of "main user" status.
Sandbox	The Sandbox Environment provides a secure, controlled space for testing changes before applying them to a live study or survey.
Create Sandbox	Grants a collaborator the ability to create a sandbox environment for active studies or surveys. This right is linked to the Study Management permission for "Study Settings," which enables access to sandbox creation. Additionally, users with either Create or Publish Sandbox rights have the ability to discard the sandbox.
Publish Sandbox	Grants a user the ability to publish changes from the sandbox to the active study or survey. This right is independent of other permissions, ensuring that only authorized users can finalize amendments. Additionally, users with Create or Publish rights can discard the sandbox.
Documents & file management	Each study has a separate section called Documents & files. Here you can upload general study documents such as the protocol, user manuals, etc.
View	Specifies who can see the documents uploaded to this section. Please note that this right does not allow to download the documents.
Update	Specifies who can upload and rename files and folders in the documents section. Please note that this requires the view right for documents & file management.
Archive	Specifies who can archive (delete) all files and folders. Please note that this requires the view right for documents & file management.
Export	Specifies who can download the documents filed in the documents section. Please note that this requires the view right for documents & file management.
Set public default views	This right refers to the subject overview of the study. Various views can be set here to include/exclude available columns for focused view. One view can be set as the default view for all users. This right gives the collaborator the option to execute this function.

Dashboards

Create	Collaborators are able to create dashboards for the study/survey.
Delete	Collaborators are able to delete dashboards for the study/survey.
View anonymized analytics data for benchmarking across all sites	With our premium feature "Benchmarking" you can compare the data of a subject against all other subjects at your site. For collaborators with a specific center affiliation such as investigators, those can only see and compare subjects at their own site. Activating this right allows you to to make comparisons of your subject and benchmark them against the anonymized data of all subjects of all sites in this study.

Reports

Configure

In addition to the standardized exports, the premium feature "Reports" offers the possibility to create and export individual reports on the study (e.g. query status, (S)AE status, data count, etc.). The configuration rights are assigned here. Export rights are set on role level.

Randomization

View	Collaborators are able to see all randomization configurations for the study.
Configure	Collaborators are able to set randomization configurations, incl. setting, updating and removing stratification variables downloading the randomization list template and uploading the randomization list removing the uploaded list extending a used randomization list
Download allocation list	Collaborators are able to download the randomization allocation list in the export module and view all available slots in the list as well as which slots have been taken by which subject.

Translations

View	Collaborators are able to see all translation configurations for the study.
Configure	Collaborators are able to set translation configurations, incl. creating languages changing languages names uploading translations updating translations enabling / disabling languages deleting languages
Download	Collaborators are able to download the translations set for a specific language.

eConsent

View	Collaborator has access to the "eConsent Forms" tab in Step 3.

✉️ Still have questions? Feel free to contact your Customer Success Manager or email us at support@climedo.de.