GCP Performance & Quality Management: eLearning Courses

“SAM” is a leader in the clinical research industry in promoting clinical quality systems for sponsors, CROs, technology vendors, and investigation sites. She has more than 30 years of clinical experience, a Bachelor of Science degree in Nursing, and a Master of Science degree in Education with a specialization in Performance Improvement. SAM is a subject matter expert in many GCP areas, including monitoring, auditing, quality risk management, vendor oversight, HIPAA and GCP global regulations and guidelines. She supports many clients with the integration of quality risk management within their quality systems. SAM also performs client clinical quality system gap analyses and facilitates improvement for efficiencies, cost containment and audit readiness for the last 15 years. She frequently authors and presents courses for clinical research pharmaceutical and medical device GCP stakeholders for various functional areas. In 2002 she co-founded Clinical Pathways (CP), LLC, a consulting firm out of North Carolina, USA. As Vice President of CP SAM has led the quality management consulting services for CP.

Course Content Aligns with Core Competency Domains

The chart below shows how the Clinical Pathways course content aligns with the core competency domains developed by the Joint Task Force for Clinical Trial Competency and Association of Clinical Trial Professionals. For additional information on Competency Domains for Clinical Research Professionals visit https://acrpnet.org/competency-domains-clinical-research-professionals/

Performance Management

DIGR-ACT® Solution DIGR-ACT® is a process developed by industry experts to improve critical thinking skills in relation to clinical trials. It helps clinical trial team members manage issues and risks that matter, to dig through and map information to the root cause, then to come to valid conclusions on how to act effectively. DIGR-ACT® is an exciting composite of well-tested approaches from other industries synthesized specifically for the clinical trial professional.

Course Length: 60 minutes     Learn More    

Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals Sponsors, CROs, and research sites are required by regulatory authorities and GCP to have an effective process to manage significant noncompliance through corrective and preventive action (CAPA) plans. These stakeholders should have procedures to support their CAPA system and documentation. Team members must understand a CAPA process and how it links into quality risk management. This training is designed to provide this understanding and is an essential companion to training on a company specific CAPA system. It is also a foundation for the CAPA process and supports understanding through GCP industry specific case scenarios and other application exercises in each section.

Course Length: 60 minutes     Learn More    

GCP Training

GCP Training: ICH E6(R2) This GCP Training: ICH E6(R2) course overviews key components of the requirements of GCP for clinical trials found in ICH E6(R2) related to the role and responsibilities of the investigator, sponsor, and other stakeholders. It covers what is GCP, then moves on to review major regulatory agencies in the United States, the European Union, and Japan, then reviews essential documentation, and finally covers good documentation practices including ALCOA-C. This ICH E6 (R2) GCP Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. 

Course Length: 90 minutes     Learn More    

GCP Refresher: ICH E6(R2) This Good Clinical Practice (GCP) Refresher course reviews the major requirements of GCP for clinical trials according to the global guideline ICH E6(R2) related to roles and responsibilities using industry case scenarios to support application and critical thinking.
This ICH E6 (R2) GCP Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Course Length: 35 minutes     Learn More    

ICH E6(R2) GCP Training for Investigator Site Personnel This Investigator Site Personnel Good Clinical Practice (GCP) course covers the requirements of GCP for clinical trials found in ICH E6(R2) related to the role of the investigator and site personnel and briefly covers roles of other stakeholders.
This ICH E6 (R2) GCP Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. 

Course Length: 60 minutes     Learn More    

ISO 14155: 2011 Medical Device Standard This course covers the ISO 14155: 2011 Standard for medical device.
Content includes an overview of the Standard, section 5: Clinical Investigation Planning, section 8: Sponsor Responsibilities, section 9: Responsibilities of the Investigator, section 6: Clinical Investigation Conduct, and section 7: Suspension, Termination, and Close-out of Clinical Investigation.

Course Length: 45 minutes     Learn More    

Medical Device versus Drug: Comparing and Contrasting This course covers comparing and contrasting medical device and drug clinical trials from an FDA (U.S.-centered) perspective and covering GCP and some global regulatory perspectives.

Course Length: 45 minutes     Learn More    

Investigator Initiated Clinical Trials This course covers investigator initiated trials (IIT), including identifying roles and expectations in IITs, steps involved in conducting an IIT, and identification of actions to mitigate risks of common pitfalls.

Course Length: 30 minutes     Learn More    

Good Documentation Practices and ALCOA-C In this course, you will learn about Good Documentation Practices, including the ALCOA-C principles, notes to file, and other general documentation procedures. Good Documentation Practices are necessary to ensure product quality and product safety. 

Course Length: 60 minutes     Learn More    

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) This course covers the international Guideline ICH E2A, which relates to Clinical Safety Data Management. Sections include a review of ICH and an introduction to ICH E2A; Definitions and Terminology related to the clinical safety experience; standards for expedited reporting; reporting time frame, the procedures for reporting, managing blinded therapy cases, miscellaneous issues, and informing Ethics Committees and Investigators; and Quality Management Systems.

Course Length: 45 minutes     Learn More    

Structure and Content of Clinical Study Reports (ICH E3) This course covers the ICH E3 Guidance as well as the E3 Questions and Answers complement. Content includes an overview of ICH E3, an overview of the clinical study report or CSR, the body of the clinical study report, conclusions and other topics related to the CSR, and the 2012 ICH E3: Structure and Content of Clinical Study Reports Questions and Answers document.

Course Length: 45 minutes     Learn More    

Overview of 21 CFR 312 (IND) and 21 CFR 314 (NDA) This course covers an overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA). Content includes 21 CFR Part 312 relating to IND Definitions, Part 312 – Subpart D about Responsibilities of Sponsors and Investigators, parts of 21 CFR Part 314 –NDA as it relates to clinical operations, and other essentials regarding cross functional readiness.

Course Length: 60 minutes     Learn More