The platform provides the ability for users to redact content at both the document and component level. A user can highlight specific text for redaction and then show or hide the highlighting during authoring. This makes the redaction process more efficient as it allows the redactions to be made at the time of initial content development. The platform will provide the ability for a user to select what type of redaction to perform: “anonymize” the highlighted content; change it to non-searchable text characters; or remove the content completely. The user can also add a reason for the redaction.
Original clinical data
The InteliNotion solution meets EMEA Policy 70 requirements for anonymization and publications of personally identifiable information from clinical data sets.
The platform allows a user to configure policy templates for a standard table format by selecting the columns in the table template and applying the deidentification rules to each of the columns. Multiple templates can be configured for the various clinical data tables generated for inclusion in the documentation. Industry standard algorithms and related privacy rules can be applied to the data columns. The privacy models supported include:
Once deidentification rule templates have been configured for table templates, the user can apply the template to the actual raw data sets by:
A relationship is maintained between the original raw data and the anonymized rendition of the tables.
The deidentification rules configured in the table template are applied to each of the columns in the raw data tables, and the anonymized set of tables are created and stored in repository. These are available to be incorporated into the CSR or submissions documents as appropriate.
Anonymized Clinical Data (Template Applied)