Centralized Monitoring

Release time:2018-11-15 Source of the article:Centralized Monitoring

The following challenges exist in current clinical trials:
The complexity of the clinical trial protocol and the resulted non-compliance:
The contradiction between the surge in the number of clinical trials and resources
Incomplete quality control system and poor process compliance

As part of the risk-based monitoring and an important complement to the on-site monitoring, centralized monitoring has the following advantages:
Reduce workload/cost with remote centralized monitoring
Detect problems early, focus on problem solving, prevent recurrence of problems
Focus on the core data and core programs of projects
Ensure the trial complies with the protocol, GCP and regulations.
Can enhance the cooperation between various functional departments, such as CTM, CRA, DM, statistics, medical monitoring and trial site members. It has got rid of the single-handed situation and a lack of communication in the past, making project management more efficient and strengthening the control of trial quality.
Centralized monitoring service:
Participate in risk assessment
Participate in defining core data and core programs
Participate in creating quality and risk management plans
Create a centralized monitoring plan
Periodically provide a centralized monitoring list/patient profile
Assess risk and participate in KAPA development

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