Learn which rights can be assigned per role in Climedo (based on study configuration) and what they entail.
⭐ In the table, you'll find the roles for which these rights are most applicable in brackets, listed under their respective permissions. It's important to note that every study is unique, so it may differ from our example. Please note, that some rights (and module) are (not) available based on the study configuration. |
Subjects (standard)
| Enroll (a subject) | The user can enroll a new patient subject in the system. (Investigator/Study nurse) |
| Update status (of a subject) | In the subject overview, the column "status" can be found. By default, the status is set to "active" after enrolling a subject. With this function, the user can set the status to three further statuses: complete, dropped, ineligible. Read more about the statuses on the following article: Subject overview in a study (Investigator/Study nurse) |
| Update done for today | This authorization is not associated with any specific function, but serves to mark the subject in the subject overview with a calendar icon to help distinguish between reviewed and non-reviewed subjects. The marking automatically resets at midnight each day. (Monitor) |
| Update Custom Subject ID* | At times, a study may require a different logic for the automatically created Subject Identification Code (SIC) than what the Climedo System offers by default, instead using manual entry of the SIC when enrolling a subject. This function also authorizes the relevant role to make changes to the SIC even after a patient has been enrolled. However, it's essential to ensure that the "allow manual entry/edits of Subject ID" option is toggled on in the general settings (Step 1) of the study for this function to be operational. Read more about this setting on the following article: How can I set up a study? (Step 1). (Investigator/Study nurse/Monitor) |
| Send ePRO manually | Only important if you use ePROs in your study. As the name implies, this function allows the role to manually send an ePRO to a subject. This feature might be useful in the following situations:
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| Update data collection method (ePRO<>non-ePRO) | Only important if you use ePROs in your study. This function provides the role with the authority to convert previously designated ePROs of a subject into non-ePROs, similar to an eCRF. As a result, roles with scheduled events update permissions (eCRF data entry permissions) can also enter data into forms that were originally intended for subject completion via ePRO. This capability proves beneficial in resolving following example situation:
The change of the collection method can be conveniently carried out in the subject overview. The change of non-ePRO back to ePRO is likewise possible with this right. Please keep in mind, that this function needs at minimum scheduled events "read" right and does not per default allow you to enter data afterwards (for this, additional scheduled event update rights are needed). (Investigator/Study nurse/Monitor) |
| Update site (of a subject) | This function enables the role to modify the subject's site affiliation. This is particularly beneficial in scenarios where a subject relocates to a different location and will continue the study participation at another site. If this case does indeed occur, we recommend reading the following article more closely: What needs to be considered when changing a subject's site? (Monitor/Data Manager/Project Manager) |
| Update assignees | In the system, the term "assignee" refers to the individual responsible for overseeing the subject during the study, often represented by the investigator or study nurse. By default, the assignee is set as the person who enrolls the subject in the system, although it can be manually adjusted during the enrollment process. With this function, the assignee of a subject can be updated even after the enrollment phase. (Investigator/Study nurse/Monitor) |
| Archive subject | In the system, "archiving" refers to a soft deletion and removing the subject from the subject overview & exports. It is irrecoverable by you or your users. It is essential to handle this function with care. Possible use case might be the enrollment of a mock test subject into the live study. If, by any chance, a subject is mistakenly archived, kindly reach out to your Customer Success Manager for assistance. Please be aware that retracting an archived subject involves significant technical effort and should only be used in exceptional circumstances. In such cases, it is preferable to consider altering the subject's status as a viable alternative. This right should be assigned with care and in general not to site personnel. (Data Manager) |
| eConsent (premium) | |
Read | A role with "Read" right is able to see the columns "Consent type", "Consent status" and "Consent name" in the subject overview without being able to change anything in the implementation itself. The "sent eConsent" button is not displayed. Please note that "subject files read rights" are currently still required for this right. |
Send | A role with "Send" right is able to initiate a signature request to an investigator and a subject as well as to assign and change an eConsent signee and manually update the status of paper consent. |
Sign | A role with "Sign" right is able to sign the consent form. |
| Self registration (premium) | A role with "Generate QR Code" rights is able to generate self-registration QR codes for a study. |
Subject Information (standard)
These rights give access the subject personal information and assigning any of those rights should be handled with utmost care to adhere to applicable guidelines and regulations!
| Read | Mostly important when using ePROs. In ePROs, it is important to provide contact information such as the subject's email address and/or mobile phone number in the system. This functionality grants the role the ability to view this information but not to edit it. Please note that there is no distinction made here between the required (email address, mobile phone number) and additional contact information (such as name, address, etc.). (Investigator/Study nurse) |
| Update | This function is what grants the role the permission to edit the aforementioned information. Please note that this function requires the "subject information read permission" in order to be utilized. (Investigator/Study nurse) |
| Export | Finally, with this function, the right can be granted to export exactly those pieces of personal information about the subject separately from the actual study data (eCRF + ePRO). Please note that this function requires at minimum the "subject information read permission" in order to be utilized. (Investigator/Study nurse) |
Subject files (standard)
| Read | In our system, there is a possibility to store additional files per subject. These subject files are located and managed within the Subject Profile section. With this permission, the contained files can be viewed and downloaded. (Investigator/Study nurse) |
| Update | With this permission, files can be uploaded into the Subject Profile (per subject). Please note that having the "subject files read permission" is a prerequisite for this right. (Investigator/Study nurse) |
| Archive | Finally, the permission can be granted to delete/remove files from the Subject Profile. Please note that having the "subject files read permission" is a prerequisite for this right. (Investigator) |
Scheduled Events (standard)
| Read | Scheduled events refers to all forms - both eCRF and/or ePRO - that have been added to the study within the study steps. This permission grants the role the right to view the entered data in both eCRF and/or ePRO but does not allow editing of either. Excluding a role from individual input forms (removing the read rights for a specific form) is configured in the actual setup of each form. For more information on this topic, please refer to the following article: How do I build an input form? (Step 3) (Investigator/Study nurse) |
| Update | This permission grants the role the right to enter data into the eCRF and/or non-ePRO. By default, a Collaborator cannot enter data into an ePRO. If this needs to be enabled however, you can use the function "Update data collection method". Refer to the applicable section under "Subjects" further above on how to configure the necessary settings. Please note that this permission requires "scheduled events read permission". (Investigator/Study nurse) |
| Export | This permission determines which role can export the scheduled events data in the respective, available data formats (PDF, Excel/CSV or both). Please note that this permission requires at minimum "scheduled events read permission". (Data Manager/Project Manager) |
PDF | see "Export" above. |
Excel/CSV | see "Export" above. |
Unscheduled events (module)
| Read | An unscheduled event refers to forms that are created as a "backup" in the system and are only added to individual subjects in case specific conditions are met. Usually, these forms capture information about comorbidities, additional unplanned medical visits, or concomited medications. They serve as supplementary data for specific subjects as needed. This function grants the role the right to only read the entered data in unscheduled events. Editing or modifying the data is not allowed with this permission. (Investigator/Study nurse) |
| Update | This permission is what grants the role the right to add forms and enter data into them. Please note that this permission requires "unscheduled events read permission". (Investigator/Study nurse) |
| Export Excel/PDF | Finally, it can be determined which role can export the entered data. Please note that this permission requires "unscheduled events read permission". (Data Manager/Project Manager) |
Data Verification (module)
Needs at least read rights of either scheduled events and/or unscheduled events, depending on where the functions are to be used.
A role can have all or any of the below options that allows them to either perform the action and/or view the status of it. (refer to details in the table).
Refer to the following articles for the configuration of signature, locking and SDV options in the applicable form settings:
| View signatures (form level) | This function is a general permission that allows the role to potentially sign input forms. The actual specification of which role can sign which particular form(s) is configured within the settings of each input form itself. Even if a role shall not sign a form, but needs to see the signature status in the Subject Overview per subject and form, this role permission must also be enabled. (Study Coordinator/Investigator/Principle Investigator/Monitor/Data manager) |
| View locking (form level) | This function is a general permission that allows the role to potentially lock input forms. However, the actual specification of which role can lock which a particular form(s) is configured within the settings of each input form itself. Even if a role shall not lock a form, but needs to see the locking status in the Subject Overview per subject and form, this role permission must also be enabled. (Study Coordinator/Investigator/Principle Investigator/Monitor/Data manager) |
| Verify (input field and/or form level) | This function is used within the context of Source Data Verification (SDV). It determines which role can potentially verify that the entered data matches the patient source. The actual specification of which role can SDV which input field(s) within a particular form(s) is configured within the settings of each input form itself. Even if a role shall not SDV a form or field(s), but needs to see the SDV status in the Subject Overview per subject and form, this role permission must also be enabled. It is worth noting that this function is independent of the Locking and Signature functions and serves a distinct purpose in the verification process. (Monitor) |
Queries (standard)
Needs at least read rights of either scheduled events and/or unscheduled events and/or (S)AEs, depending on where the functions are to be used.
| Read | With this permission, all queries can be viewed, but cannot be edited. The permission allows users to review and inspect queries without the ability to make changes or modifications. (Project Manager) |
| Update | With this permission, users can edit both manually created and automatically generated queries. Please note that the read permission for queries is required for this function. (Investigator/Study Coordinator/Principle Investigator/Monitor/Data Manager/Safety) |
| Create | With this permission, manual queries can be created and automated closed queries reopened. (Monitor/Data manager/Safety) |
| Close | This permission defines who can close a manual or automated query. (Monitor/Data manager/Safety) |
| Archive | This permission specifies who has the right to archive (remove) incorrectly or inadvertently created queries. It is worth noting that in general even "undesired" queries should not be archived/removed, but rather documented and closed as such. (Data Manager) |
| Export Excel/CSV | All queries can be exported separately and independently of other data in the available data format. However, an additional permission must be granted for this purpose. (Data Manager/Project Manager/Safety) |
(S)AE (module)
| Read | In our system, besides the data recorded in the eCRF, there is also the capability to capture (Serious) Adverse Events ((S)AEs). This permission enables the respective role to view (read) these (S)AEs, without the ability to make any edits. More than one form can be included in the general (SA)E set up. Excluding a role from viewing one of those (S)AE forms is configured in the settings of that specific form. (Sponsor/Monitor/Project Manager/Safety) |
| Create | This permission defines which role is allowed to create an (S)AE for a subject. Please note that for this permission, (S)AE read rights are required. (Investigator/Principle Investigator/Study Nurse) |
| Update | Here, it is determined which role is allowed to edit or update (S)AE form data. Please note that for this permission, (S)AE read rights are required and the role cannot be excluded from this specific (S)AE form. (Investigator/Principle Investigator/Study Nurse) |
| Sign (form level) | This function is a general permission that allows the role to sign the (S)AE forms. The specification of which role can sign which (S)AE form is configured within the settings of that form. The signing function requires the role to enter the user password. Even if a role does shall not sign a form, but needs to view see the signature status in the (S)AE Overview per subject and form, this role permission must also be enabled. Please note that for this permission, at minimum (S)AE read rights are required. ((Principle) Investigator) |
| Lock (form level) | This permission specifies who is authorized to lock (S)AE forms. Please note that for this permission, at minimum (S)AE read rights are required. (Monitor/Safety/Data Manager) |
| Verify (input field and/or form level) | This permission determines who is allowed to verify entire (S)AE forms and/or individual fields within the (S)AEs. Even if a role shall not SDV an (S)AE form or field(s), but needs to see the SDV status in the (S)AE Overview per subject and form, this role permission must also be enabled. Please note that for this permission, at minimum (S)AE read rights are required. (Monitor) |
| Export | It is possible to specify which role should be granted the permission to export data from the (S)AE module in the respective, available data formats (PDF, Excel/CSV or both). Please note that for this permission, at minimum (S)AE read rights are required. It is worth noting that site roles in general use the PDF data format only to file (S)AEs for documentation on site. (Data Manager/Project Manager/Investigator/Study Coordinator) |
PDF | see "Export" above. |
Excel/CSV | see "Export" above. |
| Archive | Ultimately, the decision can be made to grant the permission to archive/delete (S)AEs to a specific role. If, by any chance, an (S)AE is mistakenly archived, kindly reach out to your Customer Success Manager for assistance. Retracting an archived (S)AE requires significant technical effort and should only be used in exceptional circumstances. This right should be assigned with care and in general not to site personnel (Safety) |
Audit Trail (standard)
| Read table overview | In our system, every entry and modification throughout the study is logged in the Audit Trail. This permission allows you to grant roles the authority to have a general view of the Audit Trail. This access includes information such as the affected patient, type of modification, location (input form/field), content, action, collaborator role, and timestamp. (Data Manager/Project Manager) |
| Read detailed changes | Furthermore, there is a more detailed view available, providing e.g. insight into the history of an input field. In this view, old input values can be compared with new ones. Additionally, if applicable, the reason for the change (in the case of modified data entries) can be seen (GDP compliant). Please note that this permission requires "Table overview read permission" to be granted. (Data Manger/Project Manager) |
| Export PDF (premium) | Finally, the Subject Audit Trail can be exported individually for each subject. Permissions can be assigned to each role to enable this functionality. Please note that in order to have this permission, "Table overview read permission" and "detailed changes read permission" are required. (Project Manager) |
Reports (premium)
| Export | In addition to the comprehensive exports, our system also allows exporting of individualized reports. This permission specifies which role is authorized to export configured reports. (Data Manager/Project Manager) |
Randomization (premium)
| Read | A role with "Read" rights will be able to view the randomization group of a randomized subject in the subject's eCRF, the subject overview, the scheduled events export and the detailed changes of the audit trail. "Randomized by" and "Randomized at" can be viewed by every user who has access to the subject. |
| Randomize | A role with "Randomize" rights will be able to perform the randomization action per subject, meaning: click on "Randomize subject" and confirm the randomization. This right is independent from the "Read" right. |
*Custom Subject ID: Key term for Subject Identification Code (SIC). SIC: Is the naming or description of the Subject ID and can be amended per Project as needed. Example: Custom Subject ID: SIC = Subject | ||
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✉️ Still have questions? Feel free to contact your Customer Success Manager or email us at support@climedo.de. |
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