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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

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
  • Introduction of Fire – the nature and characteristics of fire
  • Vehicle Fire – how to overcome it?
  • Factors that contributing to a fire –environment causes that can trigger fires
  • Danger of smokes – ways to avoid inhaling toxic smoke in a fire
  • Identify a safe location- how to act in a smart way
  • How to escape a fire – the measures to be taken during fire
  • Consequences of fire- the chances to survive in a fire
  • Usage of the self-protecting tools / fire extinguisher
  • 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
  • To increase knowledge of where microorganism reside and how they spread
  • To learn practice to reduce the risk of cross infection
  • To understand the term standard precaution and additional precaution
PROGRAMME
  • The important of infection control
  • Standard and additional precautions
  • Sharp Injury & Post Exposure Prophylaxis (PEP)
  • Demonstration and practical session  on phlebotomy
SPEAKER
  • Ms. Norlinah  binti Ahmad (Nursing Officer, Department of Infection Control)
  • Ms. Habibah Abdul Aziz (Nursing Officer, Department of Infection Control)
  • Ms. Nor Halida bt. Abdul Latip  (Staff Nurse, Department of Infection Control)
FACILITATOR
  • Ms. Suzana bt Saaibon (Staff Nurse)
  • Ms. Haryani Che Hamzah (Staff Nurse)
  • 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