Protocol Manager is equipped with several configurable options. Some of the options pertain to particular components of Protocol Manager; some options apply to many components simultaneously.
- Cohort Management – Protocol Manager’s optional cohort processing provides users with the ability to specify cohorts at the patient and subject level. Specific patient visit streams as well as selected CRF page management can be assigned to each cohort. Investigator con-tract processing allows for cohort planning in the Protocols component as well as within the actual clinical trial. Once created, Cohorts allow the project team to easily monitor subjects according to the characteristics they define (age, disease, control group, etc). Expanding on Protocol Manager’s collaborative capabilities all reports are generated in real-time and up-to-date.
- Cross-Trial CDA Management – The CDA Management component enhances investigator relationship management by allowing the clinical team to track Certificates of Disclosure Agreements (CDAs). This component is designed to track the three types of disclosure agreements; client nondisclosures, vendor nondisclosures, and two-way nondisclosures. Up to the minute information allows project managers to learn the status of all CDAs on demand. Additionally, project managers may determine who signed a CDA and when it was signed.
- Adverse Events – Adverse Events and Serious Adverse Events must be properly tracked and reported on a trial. Protocol Manger comes enabled with the configurable (optional) ad-Watch-AE safety system. From within this module an adverse event may be reported, encoded, and submitted to the FDA or other health agency electronically.
- Trial Master File – Protocol Manager provides a configurable link to Winchester’s paraFILE document management and repository system. This option is configured and then exercise when the clinical trial team determines that they wish to “publish” Protocol Manager-managed records, documents, and attached files to the Trial Master File (TMF). Most published documents will be published in the pdf-file format.
Protocol Manager has been interfaced with many other organizations’ software products:
- EDC Integration – Protocol Manager has often been interfaced with popular, commercial EDC systems. In some cases, Protocol Manager has been interfaced with client-developed, in-house EDC systems. The integration with EDC systems provides the clinical trial managers with the ability to determine the instant status of any component of a trial.
- Excel Integration – Protocol Manager comes completely equipped with an Export to Microsoft Excel® feature for almost any data or document components contained anywhere in the system. This integration provides the maximum flexibility in reporting for users who are familiar with Microsoft Excel.
- Word Integration – Protocol Manager comes completely equipped with an active interface with Microsoft Word®. This interface is in place for the management of document templates, direct mail directly driven from Protocol Manager, and mail merge.
- Project Integration – Protocol Manager has been interfaced Microsoft Project® through the use of Winchester-developed interfaces and some recommended third-party interfaces.
- Cognos BI Integration – Dashboards and scorecards are available through an active inter-face with Cognos’ Business Intelligence system. This web-based interface allows interested users to “slice and dice” program and project information to satisfy corporate reporting requirements.