The Basic of Clinical Research

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                                                              What is CLINICAL RESEARCH?

If someone want to break in the field of clinical research here I am going to describe some basic key word related to clinical research which make it very easy to understand the backbone of clinical research, I think this topic is more interested to students. So here we go!

Basically CLINICAL RESEARCH deal with the development and effect and side effect of drug in long term, it is very necessary as it can effect the whole generation cause in one way or other evry body is taking some kind of medicine in their life.

IRB/IEC Board – It deal with the right and safety of subject (person who take part in research of medicine), and approval and disapproval of clinical trials occurring in any place.

PROTOCOL – Protocol is a method which describe objective, design, methodology, organization of the trial. i.e how trial has to be performed which rule to follow or not.

PROTOCOL AMANDMENT- If any change made in protocol made or sponsor under IRB/IEC.

INFORMED CONCET FORM – It is a form a subject voluntary fill and conform his willingness to participate in the trial.

CASE REPORT FORM (CRF)-Used for subject tracking, data analysis, monitoring by sponsor and to write final report.

SAFETY REPORTING- To identifying, documentation, reporting adverse events and serious adverse event.

GCP (Good Clinical Practice)- International standard for design, conduct and reporting of trials that involves human subject. Example Anticipate benefit, justify the risks, accurate reporting, verification and Original taken from declaration of HELSINKI.

SOURCE DOCUMENT- Original documents, data and records, laboratory notes. Etc

PRINCIPLE OF ICH-GCP- Trial should be conducted according to declaration of Helsinki.

Before trial risk and benefit should be evaluated, trial, safety and well being should be evaluated.

Trial should be conduct in compliance with protocol by IRB/IEC.

All information should be recorded, stored in accurate way and investigational product be handle according (GMP) Good manufacturing practice.

INVESTIGATOR- investigator is a qualified doctor communicating with IRB/IEC. Randomizing procedure, record, report, safety report, pre mature reporting.

SPONSOR – provide finance, notification to regulating authority about trial, information on medical product, manufacture, packing labeling, coding, adverse drug reaction reporting.

STANDARD OPERATING PROCEDURE ( SOP)- To insure that the study is planned, set up, documented according to protocol related SOP,

To insure the right, safety, welfare of study subject are properly protected.

To ensure data is generated, collected with accuracy and integrity.


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