“Human Subject Protection and GCP Training for IRB Members” (Fiscal year 2017)

Training Course:  “Human Subject Protection and GCP Training for IRB Members” 

Date : 24 – 25 November 2016 (Full Day)

Location: Pratap Singhasivanon Conference Room,

17th Floor Rajanagarindra Building, Faculty of Tropical Medicine, Mahidol University

(43 participants attended)

Gallery :

Slide: (Please click on the list of topics)

1 Assoc. Prof. Dr. Yupaporn Wattanakul

►Ethical Principles in Human Subject Research

  • A History of Ethics in Human Subject Research
  • Declaration of Helsinki
  • Belmont Report
  • Other Relevant Rules and Regulations

►Introduction to ICH GCP

  • ICH Guidelines for Good Clinical Practices
  • Vulnerability, Privacy and Confidentiality
  • Conflict of Interest

 

2 Assoc. Prof. Dr. Jaranit Kaewkangwal

►IRB Roles & Responsibility

  • IRB Composition
  • IRB Functions

 

3 Dr. Pravich Tanyasittisuntorn

►Ethical Issue in Clinical Study

 

4 Assoc. Prof. Siwali Sirilai

►Informed Consent Process

 

5 Prof. Dr. Srisin Khusmith

►Ethical Issue in Biomedical Research

  • Good Laboratory Practices
  • Types of Specimens / Secondary Data
  • Archival of Specimens / Secondary Data

 

6  Assoc. Prof. Dr. Chanya Sethaput

►Ethical Issue in Social and Behavioral Study

  • Interest of Study Participants
  • Interpersonal Relationship
  • Social Values

 

Assoc. Prof. Dr. Jaranit Kaewkangwal

►Review Process

  • Types of Review
  • Review Process
  • Notification to Investigator
  • Serious Adverse Event and Report
  • Protocol Deviation to Violation
Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s