Page 9 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

TERMINOLOGY AND ABBREVIATION

ACUC : Animal Care and Use Committee
Audit/Clinical Audit : A systematic analysis of the quality of medical care such as the
diagnostic procedure in place and/or the treatment, the use of
resources, and the resulting outcome. It is designed and conducted
to produce information to identify opportunities for improvement
and to provide a mechanism delivery of best care. It involves
comparing intervention(s) / service(s) in use and measures against
a standard clinical care / practice / guideline. Usually involves
analysis of existing data but may also include administration of
simple interview or questionnaire. There is no allocation to any
intervention on patients/subjects. [1]
BA/BE : Bioavailability/Bioequivalence
BSO : Biological Safety Officer
Clinical Trial/Research : Any investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamics
effects of an investigational product(s) and/or to identify any
adverse reactions to an investigational product(s) and/or to
study absorption, distribution, metabolism, and excretion of an
investigational product(s) with the object of ascertaining its safety
and/or efficacy. The terms clinical trial and clinical research is
synonymous
CP : Corresponding Person
CKAPS : Cawangan Kawalan Amalan Perubatan Swasta
COI : Conflict of interest
Contained Use Activity : Refers to any operation including research and de-velopment,
(in Modern Biotechnology) production or manufacturing operation involving LMO, or storage
of LMO, undertaken with-in a facility, installation or other physical
structure such that it prevents contact or impact of the LMO on the
external environment.
CRC : Clinical Research Centre
CTIL : Clinical Trial Import License
CTX : Clinical Trial Exemption
FIH : First-In-Human
GCP : Good Clinical Practice
GCP Certificate : Certificate issued by NPRA to the investigator who is able to
complete the GCP course and pass the exit exam at the end of
the course
HRRC : Hospital Research Review Committee
HRRC Reviewer : Hospital Research Review Committee Reviewer appointed by the
Hospital Director with the advice from Head of CRC
HRRC Secretariat : Secretariat for HRRC
IA-HOD-IA : Investigator Agreement - Head of Department-Institutional
Agreement
IBBC : Institutional Biosafety and Biosecurity Committee

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