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Short Training Courses





Mochtar Riady Institute for Nanotechnology
Ethics Committee is glad to organize



TRAINING ON GOOD CLINICAL PRACTICE



Friday and Saturday, 20 -21 May 2016
Venue : 8th fl, Faculty of Nursing, Universitas Pelita Harapan
Jl. Boulevard Jend. Sudirman No. 1688 Lippo Karawaci


REGISTER & FEE

You can register online by clicking on this link : http://www.mrinstitute.org/Form/2016/Form-Register-Training-On-Good-Clinical-Practice-2016.html

Payment Fee : Rp. 1.000.000,- per pax


  • The course fee includes all supporting documentation, course materials, refreshments and lunches.
  • Should be submitted at least 2 weeks before the conference/workshop (9 May 2016)
  • Please notify us via email with a scanned copy of your transaction slip or fax it once the payment has been done
  • Payment should be transferred to the following account :


Yayasan Lembaga Mochtar Riady
Bank CIMB Niaga
Cabang: Lippo Karawaci, Tangerang
Account no. : 4700 100 621 007


Secretariat MRIN EC: Mrs. Mona
Address : Jl. Boulevard Jend. Sudirman No. 1688
Lippo Karawaci – Tangerang 15881
Telp. : 62-21- 54210123, Fax : 62-21-54210110
Email : mwaworundeng@mrinstitute.org / mrin.ec@mrinstitute.org


Good Clinical Research Practice (GCP) is a necessary process that is needed to establish ethical and scientific quality and international standards for the design, conduct, recording and reporting of clinical research involving human subject.
This also ensures a uniform standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.
Following these guidelines ensures that
  • data and reported results are credible and accurate, as well as ensuring
  • 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 any untested therapy is investigated. The parties involved also should be diligent in assuring that 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.

Non compliance to the GCP guidelines will damage the scientific credibility of the researcher as well as the institution which conducts the research


Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientific quality standards for any research involving the participation of human subjects


Mochtar Riady Institute for Nanotechnology Ethics Committee (MRIN EC) has been recognized by Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) on November 2014. MRIN EC will facilitate to conduct GCP training since 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

  • data and reported results are credible and accurate, as well as ensuring
  • 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? Clinician, nurses and allied health professional biomedical and research scientists, statisticians and database managers, experience research personnel or students of Medicine ,Nursing as well as Biomedicine who are interested in any research involving human subjects or biological material.



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