GLD 12 Quiz

WHAT IS POLICY?

• series of steps or actions that are followed in a particular order to accomplish a specific task

• ability to guide, inspire, and influence others towards a common goal or vision

• set of processes, practices, and structures through which an organization or a society is directed, controlled, and regulated

• set of principles, rules, guidelines, or courses of action

WHAT IS PROCEDURE?

• ability to guide, inspire, and influence others towards a common goal or vision

• set of principles, rules, guidelines, or courses of action

• series of steps or actions that are followed in a particular order to accomplish a specific task

• set of processes, practices, and structures through which an organization or a society is directed, controlled, and regulated.

WHAT IS GOVERNANCE?

• ability to guide, inspire, and influence others towards a common goal or vision

• set of principles, rules, guidelines, or courses of action

• series of steps or actions that are followed in a particular order to accomplish a specific task

• set of processes, practices, and structures through which an organization or a society is directed, controlled, and regulated.

WHAT IS LEADERSHIP?

• ability to guide, inspire, and influence others towards a common goal or vision

• series of steps or actions that are followed in a particular order to accomplish a specific task

• set of processes, practices, and structures through which an organization or a society is directed, controlled, and regulated.

• set of principles, rules, guidelines, or courses of action

IJNREC IS AN INDEPENDENT COMMITTEE COMPRISES ALL MEMBERS AS BELOW EXCEPT

• CLINICIANS

• INVESTIGATORS

• NON-CLINICAL

• INDEPENDENT MEMBERS

HUMAN SUBJECT RESEARCH PROGRAM REFERRED TO WHICH GLD?

• 13

• 19

• 12

• 15

HOW MANY ETHICAL PRINCIPLES OF RESEARCH ON HUMAN?

• 5

• 2

• 4

• 3

BELOW ARE ETHICAL PRINCIPLES OF RESEARCH ON HUMANS EXCEPT

• RESPECT FOR PERSONS

• PDPA

• BENEFICENCE

• JUSTICE

WHAT IS THE RESPONSIBLE OF INVESTIGATOR?

• Responsible for ensuring that investigators are qualified by training (GCP) & experience, have resources & time to conduct the research is found to be scientifically sound

• Conduct INTERNAL COMPLIANCE review for all research program conducted in accordance to applicalble regulations and guidelines

• Responsible to oversight for patient protection irrespective of the sponsor of the research

• Responsible to conduct human subject research according to the ETHICAL PRINCIPLES

BELOW ARE GUIDELINES TO CONDUCT HUMAN RESEARCH SUBJECT PROGRAM EXCEPT..

• DECLARATION OF HELSINKI

• NUREMBERG CODE

• CLINICAL TRIAL AND BIOMEDICAL RESEARCH

• ICH-GCP