Using Clinical Trial Software to Manage Essential Documents
Regulatory agencies evaluate the conduct of a clinical trial and the data it generates by reviewing all essential documents. The ICH E6 guidance provides a list of essential documents that are required before a clinical trial starts, during the trial, and after a clinical trial. Using clinical trial software can be critical in managing voluminous documentation throughout the clinical research.
The Trial Master File (TMF) contains all essential documents. The contents of a TMF will vary depending on the sponsor. There are typically many contributors to the TMF: the sponsor, CROs hired by the sponsor, and the study's investigators. Robust clinical trial software can serve as a platform for the different stakeholders.
Clinical trial systems are designed to manage essential documents such as:
- Before the clinical trial: Investigator's brochure, CRF, protocol, subject materials, IRB approval documents
- During the clinical trial: Completed CRFs, updates to investigator's brochure and other documents, monitoring visit reports, subject logs, continued IRB approval documents
- After the clinical trial: Clinical study report, final closeout monitoring report, final report to IRB
The Role of CAPA and How Clinical Trial Software Can Help
The use of a corrective action and preventive action (CAPA) process is a cornerstone of any quality management system. Likewise, CAPA is critical in ensuring quality in clinical research. Even when a company doesn't have a separate CAPA mechanism, the process is typically incorporated in the quality control and quality assurance processes. When evaluating clinical trial software, choose one that includes a CAPA application.
Some companies design their clinical trial systems in a way that differentiates corrective action from preventive action:
- Corrective Action: A corrective action can be performed without the need for a preventive action. To correct a nonconformance requires performing root-cause analysis of the problem, addressing those root causes, and making sure the corrective action worked. Using clinical trial software provides the added value of making the entire CAPA process visible to the quality manager and the users, making tracking and follow up of CAPA-related tasks easier.
- Preventive Action: This is meant to avoid a problem that has not occurred yet. Preventive action entails analyzing data to determine the likelihood of the problem occurring, the consequences of the problem, and deciding if the likelihood and the consequences are minimal so as to make them acceptable, or if they are serious enough to require changing the system. When evaluating clinical trial systems, look for one that includes a process that will guide users through every step of the CAPA process.
Using MasterControl Clinical Trial Software to Ensure Quality and Compliance
The MasterControl Clinical Suite™ is a complete clinical trial software solution designed to streamline your processes by managing all documents, tasks, processes, training, relationships, and audits throughout the clinical trial.
The MasterControl Clinical Suite can help you in the following areas:
- TMF Document Management: Unlike other clinical trial systems, MasterControl includes the Reference Model-TMF JumpStart, based on the Drug Information Association's (DIA) Trial Master File Reference Model. It provides a single, web-based location for all TMF documents, making search, retrieval, and tracking of documents easier.
- TMF Project Management: MasterControl clinical trial software uses a Project Plan template based on the DIA TMF Reference Model and allows management of TMF documents and tasks as a project, providing automatic task reminders and updates when tasks are executed. Tasks can be scheduled together as a group. Dependencies between individual tasks and groups of tasks can be created.
- Clinical Site Management: MasterControl clinical trial software manages site-specific documents such as site qualification, protocol amendments, and study updates. It manages information pertaining to study site selection criteria (location, specialty, facility type, etc.) and site capabilities, as well as investigator documentation and IRB documentation.
- Clinical Processes Management: MasterControl clinical trial software streamlines deviation, CAPA, and other processes critical to GCP compliance throughout the life of a clinical trial. It offers flexibility in creating forms and checklists for managing GCP processes.
- GCP Training: MasterControl sets itself apart from other clinical trial systems with its training management capabilities. It streamlines the execution of training, including notification of training tasks, dissemination of training materials (documents, audio, video), and testing. It offers configurable questionnaire, test, and quiz setup.
- Clinical Risk Management: MasterControl clinical trial software manages risk throughout the life of a clinical trial using reporting and analytics tools. For example, users can monitor a TMF project's timelines, overdue tasks, and completion rate. Similarly, users can manage risk with the help of reports that will show a site's investigator and site qualification, audit history, deviations, etc.
Contact MasterControl for Information on Clinical Trial Software Systems
To learn more about clinical trial software systems, feel free to contact a MasterControl representative today.