ACR636

Explain the reporting requirements for Investigational Device Exemptions (IDEs), New Drug Applications (NDAs), International Organization for Standards (ISO) 14155, and EU Medical Device Regulation (MDR).

Describe the steps to develop a working rapport with the FDA, including pre-submission meetings, teleconference calls, scientific meetings, adverse event reporting, and the final clinical study report.

Explain the importance and key components of clinical research documents used in the different medical product development phases, including Investigator Brochures, Final Study Reports, study newsletters, abstracts, and manuscripts.

Write effective clinical study reports.

Design and implement an effective project plan using applied clinical and regulatory knowledge to determine the appropriate course of action and associated communication documents.