Understanding clinical compliance

Clinical compliance is a necessary part of a clinician’s profession. Clinical trials are the lifeblood of laboratory experiments and are at the root of drug development. Since clinical trials assume such significance in pharmaceuticals, it is necessary for clinical trials to be compliant with regulations. Regulations are important not only from the perspective of drug development, but also from that of safety, because clinical trials that do not adhere to regulatory compliance have the potential to cause harm and even death to subjects.

Clinical compliance has to be taught

Since the subject of clinical trials requires a high degree of clinical compliance, it is necessary for clinicians to undergo formal training on the subject. They should be aware of not only what procedures go into clinical training, but also how to be compliant with regulations. Like any other regulatory area; clinical compliance is also imparted by regulatory bodies authorized to do so by the FDA. The FDA authorizes accredited bodies to offer clinical compliance training.

Syllabi

Generally, clinical compliance training is offered for a clutch of main subjects. Clinical compliance usually requires the student to choose from among the following subjects:

  • The Drug Development Process
  • Good Clinical Practices (GCP)
  • Adverse Drug Events
  • GCP Audits
  • Ways of Monitoring Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance
  • The EU Clinical Trial Directive

Students can also choose from any of the following when it comes to electives:

  • Medical Writing
  • Writing Effective Standard Operating Procedures and Other Process Documents
  • Biostatistics for Non-Statisticians
  • Computer Systems Validation
  • cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
  • Selecting & Managing CRO’s
  • FDA Inspections of Clinical Data Systems
  • European Regulatory Procedures
  • Best Practices for Clinical Trial Project Management from Phase 1 to Phase 4

References:

http://www.ohsu.edu/xd/health/integrity/upload/clinicalcomplianceplan.pdf

http://www.cfpie.com/content.aspx?c=CCCP

 

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