An Introduction to Good Clinical Practices (cGCP) – Part 3


This course explores the relevance of Good Clinical Practices (GCP) in clinical research and trial programs. It covers clinical professional roles, clinical trial methodology, study design, protocol preparation, patient monitoring, quality assurance, ethical / legal issues and much more. This course has been created for appointed research professionals and staff i.e. Principal Investigators, Research Officers, Clinical Studies Officers, Research Nurses/Practitioners and Research Administrators who are involved directly or indirectly in clinical research studies.

Curriculum for this course:
Overview 1 min 01 secs
Learning Objectives 1 min 31 secs
Who Should Take This Course? 1 min 11 secs
Course Modules 1 min 10 secs
Module 7: Clinical Trial Protocol and Protocol Amendment(s)
Clinical Research Protocol 1 min 05 sec
Content of a Clinical Research Protocol 1 min 10 secs
General Information 1 min 08 secs
Background Information 1 min 17 secs
Trial Objectives and Purpose 1 min 07 secs
Trial Design 1 min 02 secs
Selection and Withdrawal of Subjects 1 min 10 secs
Treatments of Subjects 1 min 08 secs
Assessment of Efficacy 1 min 05 sec
Assessment of Safety 1 min 14 secs
Statistics 1 min 09 secs
Direct Access to Source Data/Documents 1 min 08 secs
Quality Control and Quality Assurance Procedures 1 min 02 secs
Ethics 1 min 10 secs
Data Handling and Record Keeping 51 secs
Financing and Insurance 1 min 11 secs
Publication Policy 58 secs
Module 8: Data Integrity in Clinical Trials
Data Integrity 1 min 12 secs
Fundamental Elements of Data Integrity 1 mins 29 secs
Attributable 1 min 02 secs
Legible 1 min 25 secs
Contemporaneous 1 min 02 secs
Original 1 min 20 secs
Accurate 1 mins 23 secs
Module 9: Essential Documents for the Conduct of a Clinical Trial
Essential Documents 1 min 01 secs
Essential Document Types 1 min 13 secs
Final Assessment

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