Viedoc 4.80 Release Webinar Q&A
This video is a recording of the webinar about the Viedoc 4.80 release:
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Viedoc Me account management
Email address validation
Q: Do we validate the subject's email address? How?
A: Yes, validation occurs only if an email address is entered. If an email address is provided, both text boxes must match in the format x@y.domain.
Country code default vs. customization
Q: Is the country code defaulted to the participant's site's country, or is it adjustable?
A: The default is set to the site's country code, but it can be changed to another country code as needed.
Language options for Viedoc Me setup
Q: Can the Viedoc Me interface be changed to another language if a participant has a different native language?
A: Yes, alternative languages are supported to improve the user experience based on participant needs.
Language customization for Viedoc Me users
Q: Can the language be changed in Viedoc Me? For example, if a patient at a Swedish site prefers another language, is this possible?
A: Yes, Viedoc Me supports language customization. The site can adjust the language from within Viedoc Clinic, and Viedoc Me users also have the option to change the language directly within their application settings.
Country code implementation in account activation
Q: Will the added country code in Viedoc Me apply to new users during account activation through Viedoc Clinic?
A: Yes, the country code is available during the account activation process for all new users setting up their accounts via Viedoc Clinic.
Document sharing and signatures
Signature document creation
Q: Does a new document version get created when signing?
A: No, a certified copy is appended with a cover page showing the signature, available in the eTMF archive.
Sharing notifications logging
Q: Are email notifications for document sharing logged?
A: Currently, these notifications are not included in communication logs. This may be addressed in future development.
Language consistency for document sharing
Q: Is Viedoc information written in the patient's language or English only?
A: Information is provided in the patient's language, ensuring clarity and understanding during document sharing.
Shared document access location
Q: Where are documents shared with a Viedoc Clinic user displayed?
A: Viedoc Clinic users receive an email link to Viedoc Share where all documents shared with the user for the specific study are accessible.
Document sharing and access controls in Viedoc
Q: Can the sharing of the document occur only through the eTMF page, or can a document be shared outside of the eTMF?
A: In the 4.80 release, document sharing can only be done from the eTMF. Future updates will include functionality to enable document sharing from outside the eTMF.
File integrity
Q: The checksum in the signed document - is that an MD5, SHA1 checksum, or is it a different one?
A: Yes, it is. We use the label File integrity to use the same terminology as the EMS.
Document sharing during review process
Q: Can only finalized documents be shared through the Viedoc Share application?
A: Yes, only finalized document versions can be shared. Documents that are still under review are not considered finalized and cannot be shared.
Access to Informed Consent documents
Q: Who will have access to the information provided in the Informed Consent form? Will the technical designer or data manager have access? If so, is it possible to obliterate sensitive data such as name and date of birth?
A: Access depends on the configuration and mapping between Clinic roles and eTMF roles. Only roles with Manage sharing permission, archivists, and read-only trial master file access can view there records. Records signed by Viedoc Me users are available only in the investigator-side archive. Documents located exclusively on the sponsor side of the eTMF cannot be shared for signature with Viedoc Me users.
Auto coding
Coding activity in audit trail
Q: Is it possible to trace all auto coding activities, including re-codings, in the audit trail?
A: Yes, both the original and the subsequent codings are recorded, with the latest version shown in exports.
Primary System Organ Class (SOC) usage
Q: Are we using the primary SOC for exact match auto coding?
A: Yes, the primary SOC is used, ensuring consistency across coding activities.
The role of Study Managers in auto coding
Q: Who can implement auto coding?
A: Study Managers can enable auto coding with MedDRA on any study running the new Viedoc Coder.
Country-specific coding integration with WHODrug
Q: Is WHODrug coding dependent on country-specific terms?
A: Yes, Viedoc integrates with WHODrug Koda, allowing for country specification to improve coding accuracy.
Q: How is the auto coding in WHODrug done? Isn't the correct WHODrug term dependent on the country? And is the correct corresponding ATC code to be selected manually?
A: Viedoc will integrate with WHODrug Koda for auto coding in WHODrug. For more information, visit Uppsala Monitoring Centre. The country can be submitted as a parameter to WHODrug Koda to improve the coding. When a user decides to submit the country, Viedoc will use the country of the site.
Export of audit trail
Q: Can the audit trail for coding activities be exported?
A: No, not at the moment. However, the audit trail is stored in the background.
CTCAE
Q: Will you be doing a coding version for CTCAE?
A: There are currently no such plans.
The availability of the auto coding functionality
Q: Who can implement auto coding?
A: Auto coding with MedDRA exact match can be enabled by the Study Manager on any study running the new Viedoc Coder. To switch to the new Viedoc Coder for an ongoing study, please contact Viedoc support.
Role-based queries
Permissions for query resolution by roles
Q: Are there roles with higher permissions for closing queries raised by others?
A: Yes, temporarily disabling role-based query restrictions allows for broader approval permissions.
High-level role permissions for query closure
Q: Is it possible to have at least one high-level permission role that can close queries raised by others? Are these query permissions adjustable?
A: If the role-based queries functionality is enabled for the study, only users with the same role as the one that raised the query can approve its resolution (not necessarily the same user, but the same role). If other roles need to approve or reject queries, the role-based queries setting can be temporarily disabled in Viedoc Admin > Study settings, allowing any role with add/change queries permissions to approve or reject queries regardless of who raised them. Enabling or disabling role-based queries for the study is logged in the Admin audit trail.
System queries and Data Manager role permissions
Q: Will only the Data Manager role be able to close system queries?
A: No, the current release of the role-based queries functionality does not restrict system queries by role. Any role with add/change query permissions can close system queries.
New columns for user role in queries export
Q: Is the new column for user role available for existing studies in the previous release?
A: Yes, the two new columns, User role and Query raised by role, are available for both ongoing and new studies and are applicable regardless of whether the role-based queries functionality is enabled in Study settings in Viedoc Admin. These columns populate mainly for manual queries, so some values may be empty, particularly for system queries.
Pre-query permissions and role-based queries
Q: Are role-based query permissions applicable to pre-queries, or does this only apply to manual queries?
A: Pre-queries continue to follow permissions for Add pre-queries and Promote pre-queries, as detailed in the Viedoc Clinic User Guide. Role-based queries permissions apply once a pre-query is released and becomes a visible query.