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Overview
Provantis™ Protocol and Report Assembly (P & RA) is a document preparation and management system that provides a departmental solution designed specifically for creating study protocols and final reports. Documents are created by combining user-defined document templates, user text, data directly extracted from the Provantis™ database, tables generated by Provantis™ and other contributing documents generated elsewhere.

Based on Microsoft Word, high quality documents, conforming to corporate presentation standards can easily be produced. Integration with the rest of the Provantis™ system achieves both consistency and faster production of documents. Significant savings in QA review time are achieved by securely managing tables, graphs and other contributions.

Template Based
Documents are based on user-defined templates that can be used to implement corporate documentation standards. The full capabilities of Word are available. Different templates can be created for each study type performed by a laboratory, or for each client for CROs.

Data Fields
Templates can also contain data fields. These are markers in the template that will be replaced by study specific text when a study document is created. Data fields can either be: user entered text; picked from a pre-defined list; any item of data in the Provantis™ database; or, a reference to a protected or unprotected contribution, which can be a table generated by Provantis™.

Data Tables
P & RA manages tables generated by Provantis™ and other applications as contributions to the final report. If a contribution is "protected" it has come directly from a generating application and cannot be modified. This eliminates the need to perform QA on the tables in the final document. Contributions can be re-formatted using the full capabilities of Word whilst protecting the integrity of the original data.

Version Control
P & RA manages the process of creating multiple versions of a document. The system can automatically show all the changes between versions, including changes in embedded contributions. Contributions are kept in separate documents until a document is printed or issued. This means that when editing a document you are not dealing with hundreds of pages.

Protocol Approval
For protocol documents P & RA manages the process of protocol approval. P & RA handles multiple signatories, fully Part 11 compliant electronic signatures, and automatically created amendments and deviations after approval.