An Introduction to Good Clinical Practices (cGCP) – Part 3
Description:
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:
Introduction
| 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 |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-903 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
An excellent introduction to the world of GCP and all that is associated with it. Really loved the data integrity aspect of the course and the emphasis on why it’s so important from the data gathering side.
Clear concise and summaries what GCP is very nicely. This course coupled with Part 1 and 2 are a key component on how we train our staff on GCP.
Related courses:
An Introduction to Good Clinical Practices (cGCP) – Part 1
An Introduction to Good Clinical Practices (GCP) – Part 2
Good Laboratory Practices: History and Regulatory Compliance
Private: An Introduction to Good Manufacturing Practices (cGMP)
cGMP – Cases from History and the Regulations
cGMP – Equipment, Validation, Complaints and Self Inspection
Contamination Control Strategies in a GMP Environment
21 CFR Part 211 Subpart B: Organization and Personnel
Contamination Prevention and Control in a GMP Environment
Corrective and Preventive Actions (CAPA)
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