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ClinfoSource Announces Online GCP Training Program for Medical Device Trials

/ ClinfoSource opens public enrollment to online training and certificate program for medical device clinical trials following FDA regulations and ISO standards. The GCP training course covers 10 presentation topics for conducting and monitoring medical device trials.

ClinfoSource (, provider of online Good Clinical Practice (GCP) training for clinical research professionals, announced today that a new online training course on 'Medical Device Monitoring' for clinical trials is now open to public enrollment by individuals and groups. The certificate program is offered as part of two complete lesson plans for site personnel and sponsors/CROs.

After 2 years of private collaboration, 'Medical Device Monitoring' becomes the 7th public online GCP training course offered by the ClinfoSource team of clinical trials educators, medical doctors, registered nurses, and clinical research associates.

ClinfoSource students are educated on current ICH-GCP guidelines, FDA regulations, ISO standards, global topics, and regulatory affairs. The new course is CME/CNE-accredited, as are all online GCP training courses and lesson plans on

'Medical Device Monitoring' covers 10 presentation topics on US regulations for medical device trials. Topics include monitoring device studies, pre-study visits, trial site initiation, Informed Consent, routine monitoring, CRF review and SDF, Safety Reporting, investigational product accountability, and drug and device trial close-out.

'Medical Device Trials - US Regulations' is a topic in the course that discusses medical device basics such as definitions, concepts, history, regulatory bodies, and device regulation pathways for introduction into commercial distribution. Specific discussion topics include Investigational Device Exemptions Regulatory Topic Areas, Enforcement Comparison and Contrasts when monitoring trials for drugs versus devices.

'Informed Consent for Drug and Device Trials' and 'Safety Reporting - Device Trials' are other topics under the 'Medical Device Monitoring' course. Discussions and multimedia presentations cover informed consent, the regulations and guidelines governing the protection of human subjects in clinical research, and the day-to-day conduct, monitoring, and safety reporting procedures required for medical device clinical trials.

Clinical research professionals interested in learning more about ClinfoSource internet-based Clinical Research Education and Compliance training for conduct and management of medical drug and device trials can visit, call Marty McGee at US +1-925-272-9251, or email for more information.

About ClinfoSource

Since 2000, ClinfoSource has been providing quality training to clinical research professionals around the world on ICH-GCP (Good Clinical Practice) guidelines, FDA regulations, ISO standards, regulatory affairs, and global topics. Training is provided in an online multimedia learning environment, with progress tracking, tests and quizzes, group forums, and peer-to-peer connectivity.

Several reputed Universities, Medical Institutions, CROs, Pharmaceutical and Medical Device companies have implemented ClinfoSource GCP lesson plans into their training programs to educate employees worldwide. To learn more, visit

Marty McGee
ClinfoSource, LLC

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