On-demand Clinical Trials Training at Your Fingertips!

LSTI has partnered with Clinical Pathways Research to deliver a full suite of off-the-shelf, on-demand, clinical trials training!  Each course is interactive with knowledge checks and assessments to reinforce critical concepts.  Courses are accessed via a learning management system (LMS) and are available to individuals or groups.

cp+lsti

Current topics include:

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.  LEARN MORE
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. LEARN MORE
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. LEARN MORE
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. LEARN MORE
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.  LEARN MORE
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. LEARN MORE

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. LEARN MORE

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. LEARN MORE

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. LEARN MORE
This course covers the legal framework for exchange of personal data from the European Union (EU) to the United States (US) known as Privacy Shield. Content includes the history of data exchange between the EU and US, how to self-certify under Privacy Shield, how it is enforced, and the future of personal data with EU’s General Data Protection Regulation. LEARN MORE
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. LEARN MORE

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. LEARN MORE

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For mor information, click a course title or contact Bill Beyer today!

Bill Beyer

Bill Beyer

Managing Director
Phone: 215 675 1800 x113