Communications and Reporting for Clinical Trials

Describe the steps to develop an ongoing working rapport with FDA including Pre-Submission meetings, teleconference calls, scientific meetings, adverse event reporting, and the final report of the clinical study.

Understand clinical research documents used in the different phases of the medical product development life cycle (concept formation, feasibility determination, pivotal clinical trials, support of regulatory submissions, scientific writing and post-market surveillance activities), including Investigator Brochure, Final Study Report, Study newsletter, subject study materials, clinical study metrics, scientific abstracts, presentations, and scientific manuscripts.

Understand and apply the FDA Reporting Requirements for Investigational Device Exemptions (IDE) and ISO 14155 and MEDDEV requirements.

Demonstrate the ability to write effective clinical reports.

Demonstrate applied clinical and regulatory knowledge to problem-solve on hypothetical case studies, to determine the course of action, to choose an appropriate communication document, and prepare the proper documentation for implementation.

Understand and apply requirements for clinical trial registration.