ISO 14155:2011 - Clinical Investigation Conduct
Section 6 of the iso-14155 describes all the activities to be performed from the start of the clinical investigation and during the clinical investigation. These include initiation visit, site monitoring, adverse event and device deficiencies reporting, documents and documentation what to do with new site personnel how to guarantee subjects privacy and confidentiality what to do for document and data control how to account for all subjects are what are auditing requirements.
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After taking this course, the trainee will know how to conduct the following according to ISO 14155:
- Site initiation,
- Site monitoring,
- Adverse events and device deficiencies,
- Documents and documentation,
- New site personnel,
- Subject privacy and confidentiality,
- Document and data control,
- Accounting of subjects,
Any party involved in a clinical investigation, primarily Sponsors, monitors, investigators, ethics committees, regulatory authorities and 3rd party reviewers.
It is advisable to have a minimum knowledge of monitoring clinical investigations of medical devices before taking this course.