Oct06

How CTMS Speaks Directly to 21 CFR & Good Clinical Practice

While Good Clinical Practices (GCP) set forth by the Code of Federal Regulations (CFR) within 21 CFR are widely accepted and utilized within clinical study management, each industry interprets these practices differently. This has led to a widespread confusion in what “quality” really means when it comes to GCP.

In a 2015 article in Applied Clinical Trials, titled Where is the ‘Quality’ in GCP?, Suzanne Tran writes, “There are more organizations participating in a study, each bringing their own experiences, interpretations of requirements including how quality is defined. How is it possible that requirements and quality be interpreted so differently?”

Later, she notes that the Code of Federal Regulation (CFR) items that pertain to GCP do not mention the term “quality” directly – wherein the confusion lies.

What are the best practices established for clinical trials?  Tran cites the following:

  • Applicable standards
  • Regulations
  • Customer requirements as
  • Guidance and industry-wide practices

Acknowledging the nuances of GCPs from industry to industry, – especially from organization to organization – there is a need for requirements to not only be clearly established, but to be controlled systematically through the duration of the clinical study. The execution of an ethical, and accurate study is contingent upon consistencies across the board, including patient recruitment and signoff, well-defined activities and parameters, and means of ensuring that all data is generated, documented and reported in compliance with GCP-applicable regulations.

Times have already changed to fit these demands. According to a recent survey conducted by Applied Clinical Trials across a number of respected research organizations, the roles within the clinical research community have changed, as there has been a 44% increase in the utilization of patient-based technology. Clinical Trial Management Software has become a crucial component in helping researchers execute ethical, accurate, and regulation-compliant studies.

Using Clinical Conductor CTMS, clinical researchers can speak to these regulations set forth by Part 11 while maintaining an increasingly efficient, and ethical research clinic. For example, CTMS software works to facilitate a site’s compliance with compliance with Part11, which demands that “electronic signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records”. While CTMS isn’t required for compliance, it makes fulfilling the requirement much easier. Clinical Conductor CTMS offers a robust and comprehensive data capture and reporting system that is consistent and built to ensure sites are meeting these standards for each clinical trial that is executed.

Ultimately, the features included with Clinical Conductor provide organizations with the functionality required to conduct their clinical trials efficiently, using this simplified the clinical trial process to advance their research operational efficiency and place more focus on their patients.

Want to know more about how Clinical Conductor CTMS can improve the efficiency of your clinical trials at your site? Contact us today to learn more!


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