WorksheetsDay 1 Morning Session
Total questions: 9
Worksheet time: 7mins
The following statements are based on the Malaysian Guideline for Good Clinical Practice EXCEPT
It details the conduct of epidemiological studies
The principles are in keeping with the Declaration of Helsinki
The information on Investigational product should be fully available to the investigator
The delegated study coordinator should be qualified by education, training and experience
The independent Ethic committee have the following responsibilities EXCEPT
Obtain Curriculum Vitae (CV) of Investigators.
Safeguarding investigator right and safety
Review investigator qualifications
Keep records 3 years after trial completion
Choose the correct statements
It is recommended by ICH GCP that IRB/IEC should include:
Protocol is a document that describe the (a) , design, methodology, statistical consideration and organisation of a trial.
The following should be included in the clinical trial protocol EXCEPT
Description of the population to be studied
Compensation to the PI
Direct access to source data/document
Trial objectives and purpose
The following information should be included in the Investigator’s Brochure to address the effects in humans:
Information on pharmacokinetics
Dose response
Pharmaceutical data
Safety, efficacy and pharmacological activities
