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[ CourseMega.com ] Udemy - Good Clinical Practice Ich-Gcp For Clinical Investigators
TORRENT SUMMARY
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Language: English | Size: 280.66 MB | Duration: 1h 21m
A complete, certified ICH-GCP E6 (R2) course for Investigators, Study Coordinators and Site Clinical Research staff
What you'll learn
Identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
Learn the 13 core principles of ICH-GCP and how to implement them in practice
Define the roles and responsibilities of Investigators
Identify common ICH-GCP inspection findings and how to avoid them
Define the roles and responsibilities of each involved key stakeholder, and key processes in clinical research
Requirements
No prior working experience or knowledge in clinical research is required to attend this course
his course is dedicated to beginners as wells as to more advanced Investigators or Site staff willing to refresh their knowledge
Description
Welcome to the complete edition of the ICH-GCP (R2) course!This course offers the a fundamental ICH-GCP (R2) course for Investigators, Co-investigators, Study Coordinators, and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials.This ICH-GCP course meets the Minimum Criteria for ICH E6 (R2) GCP Investigator and Site Personnel Training that TransCelerate has identified as necessary to enable mutual recognition of GCP training. It provides full lifetime access to GCP Revison 2, and all subsequent Revisions of the GCP by the ICH. The course is updated on regular intervals to present the most up-to-date relevant information.My name is Dr. Vincent Baeyens PhD, I have more than 20 years of experience in running Clinical Trials (phase 1 to 4) in Global and mid-size Pharma, and Biotech settings. I have worked with most of the Global as well as several niche CROs and I am also an expert in CRO Management and Oversight.In this course, you will be able to understand based on my experience the key ICH-GCP requirements to design, conduct, record and report clinical trials in humans from A to Z. We will review the role and responsibilities of the Investigators.This course will provide you with a strong foundation to prepare for successful site regulatory ICH-GCP inspections and audits.To do so, I will lead you step-by-step through the ICH-GCP E6, and you will be able to understand:What is GCP and why GCP is important in clinical researchThe link between the Declaration of Helsinki and current GCPThe definition of the key definitions of terms and concepts used in clinical research, including stakeholders and key processes involved The ICH-GCP Principles and practical advices to apply them in your clinical trialsThe detailed responsibilities of the Investigator throughout the trial, including qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reportingThe common ICH-GCP audit and inspection findings in clinical trials and how to avoid themI will illustrate the GCP concepts with several practical tips & tricks , so that you will be able to apply ICH-GCP to your daily practice from Day 1!A final Quiz at the end of the course will consolidate your knowledge.Feel free to look at the content of the course to know more and contact me any time if you have any questions!After the course, spend 1 hour with the EXPERT to answer ALL the questions that you would have!! All you have to do is to send me an e-mail with your questions and contact details, and I will set up a call with you.I am of course available personally during the course as well to answer your questions or comments!I am looking forward to seeing you inside the course!Sincerely,Vincent
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FILE LIST
Filename
Size
~Get Your Files Here !/1 - Introduction/1 - What is GCP.html
0 B
~Get Your Files Here !/1 - Introduction/1 - What is ICH English.vtt
5.2 KB
~Get Your Files Here !/1 - Introduction/1 - What is ICHGCP Revision 2.mp4
15.6 MB
~Get Your Files Here !/1 - Introduction/2 - ICHGCPHistory.pdf
50.2 KB
~Get Your Files Here !/1 - Introduction/2 - The Declaration of Helsinki English.vtt
2.9 KB
~Get Your Files Here !/1 - Introduction/2 - The Declaration of Helsinki.mp4
9.1 MB
~Get Your Files Here !/1 - Introduction/3 - ICHGCPR3OverarchingPrinciplesVersionMarch2021.pdf
11.5 MB
~Get Your Files Here !/1 - Introduction/3 - The future of ICH English.vtt
1.5 KB
~Get Your Files Here !/1 - Introduction/3 - The future of ICHGCP.mp4
5.9 MB
~Get Your Files Here !/2 - Definitions of terms/2 - Definitions.html
0 B
~Get Your Files Here !/2 - Definitions of terms/4 - GCP and Clinical Study English.vtt
4 KB
~Get Your Files Here !/2 - Definitions of terms/4 - GCP and Clinical Study.mp4
17.6 MB
~Get Your Files Here !/2 - Definitions of terms/5 - Key stakeholders in a Clinical Study English.vtt
5.2 KB
~Get Your Files Here !/2 - Definitions of terms/5 - Key stakeholders in a Clinical Study.mp4
18.7 MB
~Get Your Files Here !/2 - Definitions of terms/6 - Key Processes in a Clinical Study English.vtt
10.2 KB
~Get Your Files Here !/2 - Definitions of terms/6 - Key Processes in a Clinical Study.mp4
40.2 MB
~Get Your Files Here !/2 - Definitions of terms/7 - Examplesofsourcedocuments.pdf
34.1 KB
~Get Your Files Here !/2 - Definitions of terms/7 - Key Essential Documents English.vtt
4.8 KB
~Get Your Files Here !/2 - Definitions of terms/7 - Key Essential Documents.mp4
17.4 MB
~Get Your Files Here !/2 - Definitions of terms/8 - Investigational Products IPs English.vtt
1.1 KB
~Get Your Files Here !/2 - Definitions of terms/8 - Investigational Products IPs.mp4
4.4 MB
~Get Your Files Here !/3 - The 13 Principles of ICHGCP R2/9 - Principles of GCP English.vtt
8.6 KB
~Get Your Files Here !/3 - The 13 Principles of ICHGCP R2/9 - Principles of GCP.mp4
42.6 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/10 - Qualifications and Agreements English.vtt
3.3 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/10 - Qualifications and Agreements.mp4
10.6 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/11 - Adequate Resources ADDENDUM R2 English.vtt
4 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/11 - Adequate Resources ADDENDUM R2.mp4
11.8 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/12 - Medical Care of Trial Subjects English.vtt
1.8 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/12 - Medical Care of Trial Subjects.mp4
5.4 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/13 - Communication with IRB IEC English.vtt
982 B
~Get Your Files Here !/4 - Responsibilities of the Investigator/13 - Communication with IRB IEC.mp4
4.1 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/14 - Compliance with Protocol English.vtt
2.9 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/14 - Compliance with Protocol.mp4
9.9 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/15 - IPs Randomization Procedures and Unblinding English.vtt
3.4 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/15 - IPs Randomization Procedures and Unblinding.mp4
11.2 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/16 - Informed Consent of Trial Subjects English.vtt
4 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/16 - Informed Consent of Trial Subjects.mp4
12.3 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/16 - Informedconsentchecklist.pdf
42.7 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/17 - Records and Reports ADDENDUM R2 English.vtt
4.9 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/17 - Records and Reports ADDENDUM R2.mp4
19.8 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/18 - Progress Report and Safety Reporting English.vtt
2.4 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/18 - Progress Report and Safety Reporting.mp4
6.5 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/19 - Premature Termination or Suspension of a Trial and Final Report by Investigator English.vtt
1.3 KB
~Get Your Files Here !/4 - Responsibilities of the Investigator/19 - Premature Termination or Suspension of a Trial and Final Report by Investigator.mp4
5.9 MB
~Get Your Files Here !/4 - Responsibilities of the Investigator/3 - Investigators responsibilities.html
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