GCP WORKSHOP 03-05 JULY 2018

GCP WORKSHOP DAY 1

 
0800 - 0830 Registration
0830 - 0930 Overview of GCP and Clinical Trials and Overview of IGH GCP and its difference from the Malaysian GCP
0930 - 1000 Tea
1000 - 1100 Ethics and the IRB/IEC
  • Overview of Ethics
  • Ethical issues on Clinical Trial
1100 - 0100 Clinical Trial Protocol & Investigator’s Brochure
0100 - 0200 Lunch
0200- 0400 Informed Consent Process
0400-0430 Tea
   
   
   
   
DETAILS ENQUIRIES 
cic_staff@um.edu.my

Tel: 03-7949288
 
Download GCP Brochure

GCP WORKSHOP DAY 2

0800 -0830 Registration
0830 - 0930 Investigator’s Responsibility
0930 - 1000 Tea
1000 - 1100 Role of Study Coordinator (SC)
1100 - 1200 Working with Sponsor
1200 - 0100 Safety Monitoring and Reporting
0100- 0200 Lunch
0200 - 0400 Audit and Inspection
0400 - 0430 Tea
   
   
   
DETAILS

cic_staff@um.edu.my

Tel : 03 - 7949 2886

GCP WORKSHOP DAY 3

0800 - 0830 Registration
0830 - 0930 Specific Legal Issues in Relation to Clinical Trials
0930 - 1000 Tea
1000 - 1100 Regulation of Clinical Research in Malaysia
1100 - 1230 Self preparation for GCP Examination
1230 - 0200 Lunch
0200 -0300 Multiple Choice Question Examination for GCP Certification
   
   
   
   
   
DETAILS
cic_staff@um.edu.my

Tel : 03 - 7949 2886
 
 

GOOD CLINICAL PRACTICE WORKSHOP 2017

1) 07-09 MARCH 2017

2) 01-03 AUGUST 2017

3) 10-12 OCTOBER 2017

4) 05-07 DECEMBER 2017

INSPECTION / AUDIT PREPARATION TRAINING 2016

Title       : Inspection/Audit preparation
Date       : 1 Dec 2016
Time      : 2.30 pm- 3.30 pm
Venue    : Bilik Cendekia, Level 1, Bangunan Trauma dan Kecemasan
Speaker : Ms. Ng Lee Huang, Senior Quality Specialist, Quintiles
 

GOOD CLINICAL PRACTICE (GCP) WORKSHOP


(Endorsed by the Ministry of Health Malaysia)

This workshop is recommended for Clinical Researchers, Nurses, Pharmacist, Trial Monitors, Research Associates, Research Managers, Postgraduates candidates involved in clinical studies and other health professionals.

Objectives

  • a)To ensure that clinical research in Malaysia is  conducted in accordance with international ethical and scientific standards.
  • b)To understand the principles underlying GCP and its specific rules of conduct.
  • c)To ensure that research subjects are  protected.
  • d)To ensure data arising from clinical research is of high quality.

GCP Certificate will be provided to the qualifying candidates upon passing the examination.

This workshop is organized by CIC four times in a year.

For more information please contact:

The SECRETARIAT
Tel : 03 - 7949 2886 or 7949 2351 
Fax : 03 - 7954 1904

 

i-Research training


This internal programme was organized to give training for Study Coordinators on how to apply for new version of online application for Medical Ethics Committee approval. It is now available at my.ummc.edu.my or eservices.ummc.edu.my/iresearch

In University Malaya Medical Centre (UMMC) research involving human require clearance by Medical Ethics Committee (MEC).

The role of CIC in i-research online application is to ensure all Industry Sponsored Research (ISR) and conducted in UMMC go through CIC.

Speaker

Nor’Alia Ramlan
( Information Technology Officer, Department of Information technology)
 

Fire Prevention & Survival Campaign


This programmed is to create awareness for CIC staff regarding fire safety and workplace and home

Speaker

Miss Lanny LH (United Asia Fire Prevention Service Sdn.  Bhd)

Agenda of the programme

a)Introduction of Fire – the nature and characteristics of fire
b)Vehicle Fire – how to overcome it?
c)Factors that contributing to a fire –environment causes that can trigger fires
d)Danger of smokes – ways to avoid inhaling toxic smoke in a fire
e)Identify a safe location- how to act in a smart way
f)How to escape a fire - the measures to be taken during fire
g)Consequences of fire- the chances to survive in a fire
h)Usage of the self-protecting tools / fire extinguisher
i)Review study cases and Q&A session
 

Needle Stick Injury Course


This programmed is recommended for Study Coordinators and Research Assistant involved in clinical trials

Aim

To increase knowledge and awareness  of infection risk s and to develop  skills to minimize  the risk

Objectives

1)To increase knowledge of where microorganism reside and how they spread
2)To learn practice to reduce the risk o0f cross infection
3)To understand the term standard precaution and additional precaution

Programme

a)The important of infection control
b)Standard and additional precautions
c)Sharp Injury & Post Exposure Prophylaxis (PEP)
d)Demonstration and practical session  on phlebotomy

Speaker

a)Ms. Norlinah  binti Ahmad (Nursing Officer, Department of Infection Control)
b)Ms. Habibah Abdul Aziz (Nursing Officer, Department of Infection Control)
c)Ms. Nor Halida bt. Abdul Latip  (Staff Nurse, Department of Infection Control)

Facilitator

a)Ms. Suzana bt Saaibon (Staff Nurse)
b)Ms. Haryani Che Hamzah (Staff Nurse)
c)Associate Prof. Dr. Mohd Yasim  bin  Mohd Yusof  (Head Department of Infection Control)

 

Sharing Session on Quality Issue by Quintiles


This programmed is recommended for Principle Investigators and Study Coordinators whose involve in Quintiles trial

Content of the programmed
 
A.Common source documents:
 
  • Subject Medical Files
  • Template Source Documents
  • The Case Report Form (CRF) or electronic CRF (eCRF),
  • Subject Generated Data
  • Use of Electronic Records
  • Other Supporting Documentation
  • IVR Systems
B.Labelling and organisation of source documents
C.Investigator review of source documents
D.Some tips on completion of source documents
E.Process of source data verification (sdv)
F.Objectives of source data verification
G.ites sops on source documents and data