Protocol Manager is comprised of several integrated configurable components that work together to form a complete Clinical Trials Management System (CTMS).
Protocol Manager can interface with your EDC system. Events recorded in each system can apprise the other system of the completion of the event or that an anomaly has occurred. The functions of the modules that comprise Protocol Manager are briefly described below:
- ParaAdmin – The ParaAdmin component allows your company to specify how you will use Protocol Manager. It provides the ability to configure the functionality of Protocol Manager based upon your business needs. As your requirements evolve over time, you may modify the configuration to add more scope and/or components of the system.
- Study Management – The Study Management component called Protocols is used in the overall planning, monitoring, and managing of a Clinical Trial. Protocol is the business engine which drives the entire trial process. From Protocols, a trial is designed to meet the conditions set for by the trial protocol. Protocols also provides on-line views and reports on the metrics and status of the trial and activities that are taking place during a trial.
- Trial Portals – Portal allows for the custom presentation of trial information to the Sponsor, CRO, Investigator sites, IRBs/ECs or any organization involved with the trial. Portal allows an on-line interchange between trial members using the latest instant messaging and team meeting technology as well as full-text search available on the Internet.
- Investigator Knowledgebase – The Investigator component tracks the organization and contact profiles of the investigator sites, labs, IRBs, and ECs. Including current activities, trials that the Investigator has participated in and Investigator related documents. By utilizing the Secure Login capabilities of Winchester’s ComPac GxP, investigators can enter into the system through the Investigator portal and update their own information.
- Trial Documents – Electronic document management on a trial can provide a significant advantage in time and cost savings as well as producing higher quality information. The document module in Protocol Manager stores all of the bespoke documents associated with a trial (1572, CV, ICF, etc…). Documents managed under this module have full version control and check in/check out control. Documents may be scanned directly into the system or attached if they already exist in an electronic format. Once added to the module they are enabled with workflow and review capabilities as well as expiration and notification attributes.
- Patients and Subjects – The Patients and Subjects component tracks all activities and information around a subject enrolled in a clinical trial. The subject profile record is tracked along with Visit and Schedule information. CRF pages Queries and Protocol Deviations are also tracked within Patients and Subjects. Ad-hoc visits, Ad-hoc CRF’s, Cohorts, and multi-leg trials are all easily handled by this powerful and flexible module.
- Investigator Payments – Complete Investigator contracts and payment triggers and information may also be enabled for this system.
- Vendor Management – The Relationship Management module provides outsourcing managers with the ability to save and manage vendor proposals and contracts and match services and activities to vendor invoices. Similar to Investigator financial management, when invoices are accepted and approved, payment items are relieved against the contract and the trial financials are updated to reflect the budget and payments to date.
- Monitoring – Trial monitoring is an “embedded” component of Protocol Manager. Monitoring begins with appointment scheduling and follows the monitoring workflow through to the approval of the monitoring and trip report. Issue management is a feature of the system, allowing the CRA to enter and report on issues as related to specific monitoring questions or general issues that need to be noted and resolved. Open (unresolved) issues are automatically carried forward to the next monitoring visit and report, enabling the CRA to better plan the next site visit. Trial and site metrics are also automatically available to the Monitor such that information is entered only once in the system.
- Inventory – The Inventory component provides for the management of clinical supplies, other materials, and investigational products. Individual item masters and kits describe the clinical supplies and investigational products on a trial including the ability to develop inventory stocking and issuing plans. Inventory helps manage items from any number of distributors on a trial. Inventory tracks the lot and batch numbers of the investigational products as well as expiration and recall dates. In addition to shipment kits, medical supplies and other site essentials may also be tracked within Inventory.
- Patient Registry – The Patient Registry component manages for a call center operation for the evaluation of prospective patients on a clinical trial. Patient Registry contains a list of qualifying questions, as defined by the protocol. Additionally marketing and follow up questions may be recorded. By utilizing this component of Protocol Manager, a list knowledge base may be developed and maintained and a reservoir of potential trial subjects for future studies is developed.
- Activity and Expense Reporting – Trial personnel can enter their time and expenses in the Activity and Expense Reporting component. Once entered, this information provides an accurate and up-to-date costing on the clinical trial. Through Activity and Expense Reporting, it is possible to review the budget information, compare actual versus forecast and budgets, and more accurately plan the expense of future projects.
- Report Manager – Report Manager allows for Ad-hoc reports or stored reports across databases and across studies. By utilizing Report Manager, an authorized user may generate a repetitive or custom, graphical report of information on the trial.