Introduction to The Role of

Clinical Research Associate

Nurul Hidayah
March 7, 2022
Clinical Research
Any planned experiment in human subjects with the aim to discover or
verify the clinical or pharmacological effects (efficacy, safety, kinetics)
of an investigational product (drug, medical device, diagnostic
tools/materials).
Good Clinical Practice
An international ethical and scientific quality standard for designing,
recording and reporting trials that involve the participation of human
subjects.
The Goals of GCP
• To protect the rights, safety, wellbeing, integrity and confidentiality of
subjects.
• To assure that data and trial results are credible and accurate.
Cara Uji Klinik
yang Baik (CUKB)
 Before CT Conduct

Essential Documents in Clinical Trial (1)

INVESTIGATOR SITE FILE (ISF)

TRIAL MASTER FILE (TMF)

 Before CT Conduct

Essential
Documents
in Clinical
Trial (2)
 Before CT Conduct

Essential
Documents
in Clinical
Trial (3)
 Before CT Conduct

Essential
Documents
in Clinical
Trial (4)
 During CT Conduct

Essential
Documents
in Clinical
Trial (5)
 During CT Conduct

Essential
Documents
in Clinical
Trial (6)
 During CT Conduct

Essential
Documents
in Clinical
Trial (7)
 After CT Conduct

Essential
Documents
in Clinical
Trial (8)
THANK YOU