Welcome & iGCP Programme Overview

Good Clinical Practice for Healthcare Professionals Online Course

 

  • iGCP was developed by 2 pharmacists with more than 10 years experience working in clinical research industry. Both have regional and international experience in clinical trial conduct with direct knowledge in the pharmaceutical environment.
  • This self-paced online course provides an overview of the various stages of clinical research to help Healthcare Professionals, especially Doctors, learn about the role & responsibilities of an Investigator, as well as the International ICH Guidelines and Good Clinical Practice GCP.
  • Upon completion, you will have the basic knowledge and understanding in the conduct of a clinical trial.

Programme Overview

 

  • This course is designed for Health Professionals with little or no prior experience in clinical trials.
  • The online self learning course will simulate you as an Investigator, and take you through a case study where you will learn in a chronological order, the way Clinical Trials are being conducted.
  • This course will prepare Doctors and other Health Professionals to become proficient in the International ICH Guidelines and Good Clinical Practice GCP, so as to undertake the role & responsibilities of an Investigator confidently in future.

Online Self Learning Course

 

  • The case study will incorporate 23 clinical trial topics. Each topic has a quiz associated with it. Each quiz will address a specific aspect of GCP covering practical interpretation and implementation of the GCP regulations.
  • Actual examples of typical issues encountered in a clinical trial will be incorporated into the case study to allow you to apply your learning and thereby enhance your GCP understanding and practical interpretation.

Certification

 

  • The GCP test consists of 50 multiple choice questions to be completed within 60 minutes. You will have 3 attempts to complete and pass the GCP test.
  • One must achieve a minimum score of 70% to pass the GCP test.
  • A Certificate of Completion will be issued by NUSAGE when you have passed the iGCP test.
  • The Certification will allow you to be part of an elite group of Health Professionals who are within the radar of Pharmaceutical Companies and Contract Research Organizations, who may contact you to explore opportunities in conducting Clinical trials as an Investigator in future.
  • The certificate is valid for a three year period.
  • All certificates issued before 21st Feb 2012 will automatically be extended with one more year validity.

Continuing Education Credits for Doctors and Pharmacists

 

  • The Singapore Medical Council (SMC) has approved the online iGCP course as Category 3B activity. Doctors will have to submit 18 Cat 3B credit claims upon completion of the programme and furnish the Secretariat with the certification of completion to verify the claims.
  • Pharmacists who successfully complete the programme will be able to claim 18 CME points under category 3A as well.

Domain Specific Review Boards (DSRB) Approval by NHG Research Ethics Committee

 

  • NHG Research Ethics Committee has approved the iGCP as alternative minimum training program. Investigators who pass the iGCP Test and submit the iGCP Certificate of Completion to DSRB will be recorded as having fulfilled the DSRB minimum training in ethics requirement.

eLearning

 

  • Please click here to register for the iGCP on-line course.

iGCP Course Content

iGCP Topics

  1. Introduction to Clinical Trials

1.1. Background of Clinical Research

1.2. Drug Development Process

1.3. Principles of ICH GCP

1.4. Investigators’ Responsibilities

 

  1. Before Trial Starts

2.1. Feasibility Study

2.2. Pre-Trial Visit & Site Selection

2.3. Infomed consent checklist

2.4. Contracts and Agreements

2.5. Institutional Ethics Committee & Health Authority Submission

2.6. Investigators’ Meeting

2.7. Site Initiation Visit

 

  1. During Trial Conduct

3.1. Subject Recruitment

3.2. Informed Consent Process

3.3. Source Data

3.4. Investigational Products

3.5. Monitoring Visit

3.6. Safety Reporting

3.7. Communications with Institutional Ethics Committee & Health Authority

 

  1. After Trial Conduct

4.1. Unblinding & Investigational Product Reconciliation

4.2. Close-Out Visit

4.3. Archiving

 

  1. Miscellaneous

5.1. Essential Documents

5.2. Audits & Inspections

Sample templates

  • Protocol
  • Sample Informed Consent Form (English)
  • Sample Clinical Trial Agreement
  • UPIRTSO form

Glossary & References

Glossary

References:

  1. Introduction to Clinical Trials

Module 1.1 Background of Clinical Research

US FDA Home Page

History of the FDA

Significant Dates in US FDA Law History

United States Holocaust Memorial Museum

Holocaust Encyclopedia

The Doctors Trial: The persons accused as guilty are

The War Crimes: The Experiments included are …

Declaration of Helsinki

Declaration of Helsinki Historical & Contemporary Perspective

World Medical Association

Belmont Report

Tuskegee Study of Untreated Syphilis in the Negro Male

Office of Human Subjects Research

Office for Human Research Protections (OHRP)

CIOMS Homepage

What is CIOMS?

ICH Homepage

ICH E6: Good Clinical Practice

K T Woo, Singapore Med J 1999; Vol 40(04).

 

Module 1.2 Drug Development Process

Frequently Asked Questions on Patents and Exclusivity

Frequently Asked Questions on the Patent Term Restoration Program

Drug Patent Watch

FDA 2006 Guidance for exploratory IND studies

Clinical Trial Statistics from Health Sciences Authority

 

Module 1.3 The Principals of ICH GCP

Guideline for Good Clinical Practice E6(R1) version dated 10 June 1996

ICH Efficacy Guidelines

 

Module 1.4 Investigators’ Responsibilities

Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects

Medicines Act ( Chapter 176)
Medicines (Clinical Trials) Regulations 7.
– Principal Investigator to supervise clinical trial
Medicines (Clinical Trials) Regulations 21.
– Duty to comply with guidelines and instructions of licensing authority

 

  1. Before Trial Starts

Module 2.4 Contracts and Agreements

FDA Form 1572

The FDA’s Oversight of Clinical Investigators’ Financial Information

Financial Disclosure by Clinical Investigators

Guidance for Industry – Financial Disclosure by Clinical Investigators

 

Module 2.5 Institutional Ethics Committee & Health Authority Submission

National Health Group DSRB Ethics Review

Singhealth Clinical Trial

Parkway Independent Ethics Committee (PIEC)

HSA Application for a Clinical Trial Certificate

 

  1. During Trial Conduct

Module 3.2 Informed Consent Process

OHRP Informed Consent Frequently Asked Questions

Medicines Act ( Chapter 176)
Medicines (Clinical Trials) Regulations 11.
– Consent required to use person as subject in clinical trial
Medicines (Clinical Trials ) Regulations 12
– Clinical Trials in emergency situations
Medicines (Clinical Trials ) Regulations 13
– Coercion
Medicines (Clinical Trials ) Regulations 14
– Duty to give full explanation and information

 

Module 3.6 Safety Reporting

E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

Guidelines on Serious Adverse Events (Drug-Related and Unexpected) Reporting in Clinical Drug Trials

DSRB UPIRTSO Report Form

DSRB UPIRTSO Report – Annex A: Multiple Studies Reporting

DSRB UPIRTSO Reporting Table (For mass reporting of overseas events only)

Singhealth Clinical Trial

PIEC Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) Report Form

http://www.niaid.nih.gov/ncn/sop/adverseevents.htm

 

  1. After Trial Conduct

Module 4.3

Good Laboratory Practices

 

  1. Miscellaneous

Module 5.2

Audits and Inspections

1) FDA Inspections of Clinical Investigators

2) EMEA : Inspections – Good Clinical Practice

3) NHG-DSRB – Internal Audits

4) Health Sciences Authority: Guideline on GCP Compliance Inspection Framework

iGCP Clinical Trial Anatomy

Anatomy of Clinical Trial

 

Before Trial Starts

Feasibility Study

Pre-Trial Visit & Site Selection

Contracts and Agreements

Institutional Ethics Committee

Health Authority Submission

Site Initiation Visit

 

During Trial Conduct

Informed Consent Process

Monitoring Visit

Patient Recruitment

 

After Trial Conduct

Close-Out Visit

iGCP Test

Certification

Online Self Learning Program:

  • The i-GCP test consists of a total of 50 multiple choice questions. You will be given 60 minutes to complete the GCP test.
  • One must achieve a minimum score of 70% to pass the GCP test.
  • A Certificate of Completion will be issued by NUSAGE and iGCP when you have passed the iGCP test.

iGCP Fees & Registration

Fees

$300 for the on-line iGCP module.

All fees are to be paid in full before the course commences. All fees indicated above are inclusive of Goods and Services Tax with effect from January 2009. The fees indicated above are subject to changes at any time.

 

Payment Modes

Cheque

Made payable to National University of Singapore and indicate at the back of the cheque Name of Registrant and “iGCP online course registration“.

Mail the cheque to:

NUSAGE

Department of Pharmacy,

Faculty of Science,

National University of Singapore,

18 Science Drive 4,

Singapore 117543

Republic of Singapore

 

Credit card

If you would prefer to pay by credit card, please write to Ms Tan Shuyun (phats@nus.edu.sg) indicating your name, credit card number and expiry date for us to process your payment.

 

IVLE Login Account

  • ID and password access to the on-line module will be issued once payment is received.
  • The ID and password to the module will be valid for a period of 2 months from the date of receipt of payment, up to the last day of the second month and not more than 90 days from date of access. Extension of access period once only and up to 30 days can be granted for a fee of $50.00.

 

Registration

Click here to register.

Clinical Trial Industry Courses

Good Clinical Practice Workshop (2 days)

Past programme agenda (new programme agenda will be updated at a later stage)

Date: 30 and 31 July 2010, 9am to 5pm, over 2 days
Location: NUS Pharmacy Department, Global Classroom

 

Good Clinical Practice Workshop

Date: 28 April 2010, 9am to 5pm
Location: Resorts World Sentosa Convention Center, Pisces 1 or 2
RWCC layout
Directions to RWCC

 

2010 Symposium on Building a Research-based Healthcare Service in Singapore

Date: 29 April 2010, 9am to 5pm
Location: Resorts World Sentosa Convention Center, Pisces 1 or 2
RWCC layout
Directions to RWCC
more

 

Contact iGCP

If you have any enquires, feedback or suggestions regarding this course, please email us at PHABOX7@nus.edu.sg.