GOOD CLINICAL PRACTICE WORKSHOP

 

WORKSHOP SCHEDULE

GCP is a set of rules and regulations that is provided by ICH, an international body that regulates clinical trials involving human subjects. It is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the

  data and reported results are credible and accurate, and
  that the rights, integrity and confidentiality of trial subjects are protected.

 

Why GCP?

In clinical trials, the protection of the subject is paramount especially when untested therapy issued. There must also be assurance about the conduct of clinical trials in terms of elimination of cheating, fraud or accidental error. Problems of poor study design must be avoided. Adherence to GCP is vital otherwise, subjects participating in the trials may be put at risk or the clinical trial data submitted may be rejected by health authorities and the scientific committee, if found to be unreliable. Also, the research credibility of the researcher and the research institution may be damaged.

Malaysia adopted GCP in 1999, and since then doctors are required to undergo training on GCP leading to certification prior to participation in clinical trials. This course is specifically designed to meet this requirement.

Objectives
To understand the principles underlying GCP and its specific rules of conduct
To provide experience in the key skills required through simulation in classroom setting
To provide some of the resources required to design and to conduct GCP trial
To achieve an overall understanding on how to conduct GCP compliant clinical trial

 

Who Should Participate?

Clinicians, nurses and allied health professionals involved with research
Research Associates and Study Coordinators
Biomedical and research scientists
Statisticians and database managers
Experienced research personnel who are interested in updating their knowledge regarding GCP

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QUOTE OF THE WEEK

'A theory is something nobody believes, except the person who made it. An experiment is something everybody believes, except the person who made it.'


Albert Einstein
Nobel Prize Laureate (Physics)