Day 1 Morning Session

Is developed by World Medical Association

Is applicable to interventional studies but not to studies on identifiable human samples

Has been updated multiple times

in accordance with Declaration of Geneva

in GCP-compliant manner

in accordance with the Declaration of Helsinki

prior to protocol review by IRB/IEC

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

Obtain Curriculum Vitae (CV) of Investigators.

Safeguarding investigator right and safety

Review investigator qualifications

Keep records 3 years after trial completion

at least 5 members

at least one member whose primary area of interest is in a non-scientific area

at least one member whose area of specialty is religious affair

at least one member who is independent of the institution / trial site

It doesn’t-it’s the sponsor responsibility

Annually

At the end of trial

The frequency is not specified

Description of the population to be studied

Compensation to the PI

Direct access to source data/document

Trial objectives and purpose

Information on pharmacokinetics

Dose response

Pharmaceutical data

Safety, efficacy and pharmacological activities