This 3 day, interactive Standard Operating Procedures (SOP) Writing Course for clinical research is designed for the novice or experienced clinical research professional who is required to oversee, administer, manage, write, implement or evaluate procedures – SOPs - for investigational sites, institutions or Institutional Review Boards (IRBs). Both the US Food and Drug Administration (FDA) and Office of Human Research Protection (OHRP), have documented their expectations for SOPs to be in place and adhered to.

This 3 day, interactive Good Clinical Practice (GCP) training course is designed to provide CRAs, Research Coordinators, Investigators, IRB and Clinical Research staff with a thorough knowledge and understanding of Good Clinical Practices (GCP) for drugs and biologics clinical research conducted under the US FDA Code of Federal Regulations (CFR), associated guidances and guidelines as well as the ICH E-6 Good Clinical Practices Guidelines. Through lectures, activities, exercises, case study review, and multi-media tools, attendees practice applying the regulations/FDA Guidance Documents in situations that they will encounter 'on the job'.

This course is designed as a ‘high level’ overview of Good Clinical Practices that provides attendees with the knowledge and understanding of Good Clinical Practices (GCP) for clinical research conducted under the US Code of Federal Regulations (CFR). ICH E-6 Good Clinical Practices Guidelines are also discussed.

This 3 day, interactive Good Clinical Practice (GCP) training course is designed to provide CRAs, Research Coordinators, Investigators, IRB and Clinical Research staff with a thorough knowledge and understanding of Good Clinical Practices (GCP) for medical device (IDE/SR) clinical research conducted under the US FDA Code of Federal Regulations (CFR), associated guidances and guidelines, ISO 14155 Medical Device Clinical Investigations and EU Medical Device Directives and Amendments. Through lectures, activities, exercises, case study review and multi-media tools, attendees practice applying the regulations/FDA Guidance Documents in situations that they will encounter 'on the job'.

*Note: This course does not address 510 (k) device regulations*