WebDCU™: Regulatory and Project Document Management Module
Regulatory Document Management
Regulatory documents can be divided into two categories: site documents and personnel documents. Site documents must be submitted for each site and are independent of the study team. Personnel related regulatory document requirements depend upon the roles of each member of the study team. As a result, when study teams change, the regulatory documents required for the study team change. Most regulatory documents have a limited lifespan and require renewal prior to the expiration date. In addition, all submitted regulatory documents should be reviewed and approved by a regulatory document manager. WebDCU™’s Paperless Regulatory Document Management module addresses all of these challenges and, like all modules in WebDCU™, utilizes generic data entry and data retrieval user interfaces in order to maintain a high level of performance reliability.
Prior to study initiation at the site, the study teams at each site must be defined and the study required regulatory documents must be uploaded into WebDCU™. Based upon the regulatory requirements of the study and the role of the study team members at the site, a list of required regulatory documents is automatically generated in WebDCU™. As the sites submit these documents, Regulatory Document Coordinators review them for completeness and accuracy and communicate to the sites any corrections or additions that need to be made to the documents prior to enrollment of any subject into the study. Once a site has uploaded all of the necessary regulatory documents and site personnel have undergone the required training, the site is released to enroll subjects into the study.
Throughout the study, periodic review of these regulatory documents is conducted by Regulatory Document Coordinators and automatic alerts and email notifications from WebDCU™ remind sites of upcoming expiration dates.
Project Document Management
WebDCU™ allows for the most current version of all study documents to be housed in one convenient location accessible to all WebDCU™ users. Study documents include, but are not limited to, the protocol, informed consent templates, worksheets for data collection, manual of procedures, and Investigator’s Brochures. The current version of each study document will be available as a PDF file on the study website and can be printed, as needed, by study personnel. This module facilitates version control of all study related documents, particularly as documents may change through the course of the study.
