This clinical procedure explains the basics of clinical investigations, but if you are looking for a CER procedure you want SYS-041 instead.
Clinical Procedure (SYS-009)
Purpose – The purpose of this (13)-page procedure is to define the process for managing clinical studies and post-market clinical follow-up (PMCF) studies.
Scope – This procedure provides an overview of managing clinical studies for medical devices. This is the primary document meeting the applicable regulatory requirements for Clinical Studies and PMCF Studies as defined in your company’s Quality System Manual (POL-001)…
This procedure is meant to be a high-level procedure for companies that are outsourcing clinical investigations to a Clinical Research Organization (CRO). If your company intends to hire a Clinical Research Coordinator (CRC) and Clinical Research Associates (CRA), then you will need to create work instructions for site selection, site training, site monitoring, patient recruitment, etc.
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