Clinical investigation of medical devices for human subjects - Good clinical practice (GCP)

Good Clinical Practice (GCP) is a well-known and important quality concept in clinical trials. As we all know, ISO14155 GCP compliance is required when collecting clinical evidence during device development, and some post-market studies. The set-up and execution of studies is always a complex process that can cost a lot of time and money. By implementing GCP correctly these studies pay off by providing valuable clinical data and knowledge about your product. Good quality data convinces regulators to approve your products, and physicians to use your products. GCP is really a quality guidance that reminds you of; the necessary steps to take; that safeguards ethics; keeps documentation structured and traceable. GCP compliance can really simplify your life. During our GCP training, we share real-life examples of situations that we come across.
Common audit findings include protocol compliance issues, lack of oversight and control, lack of good documentation practice (GDP). Most findings can be prevented by good consideration of all GCP aspects at the start of your trial. Your clinical strategy at the beginning of a project, and how you translate those into instructions and documents (e.g. protocol, case report forms (CRFs), trial master file (TMF) and operational plans), are the key to high-quality data output. GCP is a standard, but the implementation of GCP is a case of learning-by-doing. Within our CRO, GCP compliance is a daily recurring activity and a habit. Make GCP compliance your everyday habit and you will experience the advantages in the short- and long-term!

Sign up for our ISO14155 GCP Training on 12 June 2018! 

Loes

Loes Pelgrim
Post date: June 04, 2018
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