Clinical Site Monitoring

A Risked-Based Approach

Oversight of clinical investigations by sponsors and clinical research organizations (CROs) is critical to the protection of human subjects and the conduct of high-quality studies. Clinical investigations involving human drugs, biological products, and medical devices, require effective monitoring to provide oversight and to ensure adequate protection of the rights, welfare, and safety of human subjects as well as the quality of the clinical trial data submitted to regulatory authorities. Risk assessment analysis of a clinical study can vary dramatically. Having the ability to easily modify approaches to monitoring activities based on risk provides an efficient use of resources as well as a higher quality of study data.

A high quality monitoring plan will dictate the frequency and duration of the visits as well as the “risk areas” a monitor should focus on for each study. Ensuring a site has acquired the necessary approvals, complete study documentation, is adequately trained on the protocol, and that the investigator fully understands his/her responsibilities will increase the quality and compliance of the overall study. Additionally, a formal clinical site closeout procedure ensures that all parties are well informed of the conclusion of the study and that all parties involved are well informed of the overall reason for and outcomes of the study.

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The MasterControl CQMS™ Clinical Solution Package includes three (3) out-of-the-box clinical monitoring templates. These clinical monitoring forms are electronic forms designed to be used by a clinical monitor when conducting clinical site monitoring visits. Based on the type of visit, each form will focus on various different aspects of verification of information throughout the clinical trial.

Clinical Solutions Packages

Clinical Monitoring Challenges

MasterControl Clinical Monitoring Solution

Designing monitoring plans and supporting documentation targeting areas of risk on a study by study basis.
MasterControl Clinical Solution Packages are designed to be configurable on a study by study basis. Configurability enables study teams to design monitoring checklists/forms focused on areas of risk as identified in a risk management plan for a study.

Ensuring consistency in monitoring activities across all clinical monitors to ensure consistence throughout the review of site activities.
The use of MasterControl monitoring visit forms across clinical monitoring teams ensures that all monitors will work off of the same checklists and that required form fields are prepopulated as part of regular monitoring activities. This results in more complete data collection and better quality of data for tracking and trending.

Identify and follow-up on findings during monitoring visits to ensure closeout of action items between monitoring visits.
MasterControl Clinical Solution Packages are embedded with “action item tasks” that can be launched throughout various steps of monitoring. These action item tasks are automatically sent to the assigned users’ tasks list. They can include due dates and instructions and will be linked to the originating monitoring visit report.

Ability to easily access all past monitoring visits and open action items from visit to visit to ensure follow-up and updates.
MasterControl Clinical Solution Packages include out-of-the-box report templates that enable tracking and trending across products, studies, and sites including open tasks, assignees and more. Additionally, as subsequent monitoring visits are conducted, open data (i.e., action items and notes) can be linked to new monitoring visit reports to provide transparency between visits.

Ability to link monitoring visit reports across visits, sites and studies for reporting, analytics and tracking and trending.
MasterControl Clinical Solution Packages include out-of-the-box report templates that enable tracking and trending across products, studies and sites.

Ability to link monitoring reports to protocol deviations and clinical corrective and preventative actions (CAPA) for issues raised across sites and studies.
MasterControl Clinical Solution Packages are fully integrated monitoring, protocol deviation and clinical CAPA quality event management solutions with standardized data designed to facilitate the ability to analyze and report on quality trends and statistics.

Features and Benefits of MasterControl Clinical Site Monitoring

  • Risk-based Monitoring: Ensures consistency across study sites for monitor to focus on “risk areas” to particular studies in order to improve quality and efficiency.
  • Follow-up task management: Gives user the ability to launch “action item” tasks and assign users to follow-up on actions if/when needed and identified to ensure readiness as follow-up to site initiation.
  • Reporting: Out-of-the box reports for quick analysis and tracking/trending across sites and studies.
  • Clinical monitoring best practices: Provides best-practice electronic forms that can guide clinical monitoring teams through every step of ensuring the quality and compliance of various aspects of monitoring, including: site readiness, training records, source data verification, documentation, pharmacy, laboratory, investigational product (IP) accountability, adverse event (AE) reporting, informed consent, patient records and closeout procedures.
  • Complete monitoring transparency: Increased transparency of information captured and shared between monitoring visits via integration of information between monitoring visits (i.e., site initiation, site interim and site closeout).
  • Launch actions tasks: Provides monitors the ability to launch “action item” tasks as well as protocol deviations and/or clinical CAPAs and assign users to follow-up on actions if/when needed.

For More Information on MasterControl's Clinical Management Software Systems

For more information about our clinical management software systems and jumpstart options, please feel free to contact a MasterControl representative.