Custom Search

Thursday, February 17, 2011

Clinical trial protocol clinical research clinical study protocol

Protocol of a clinical trial :
The term protocol refers to a document where in methods and procedures of any scientific experiment or a examinations or a study is predefined and written in a format so that when they are followed it produces reproducibility in the process or procedures in any scientific examination or an experiment, it also helps in understanding the principals and objectives and methods involved in the examination or an experiment or a study.
Protocol of a clinical trial is a document which provide complete information in detail about a study plan upon which a clinical trial is based, it describes objectives of a clinical trial, why there is a need of caring out the said clinical trial, clinical trail protocol also describes design and the methodologies for clinical readings and their statistical evaluations, with the objective of finding satisfactory answers about safety and efficacy of a treatment or therapy or a drug or a medical device. Participants assigned to a protocol are regularly seen by researchers and doctors to evaluate effect of a treatment, therapy or a drug or a device on their health.

Clinical trial protocol also describes about, who can participate in there clinical trail, as well as test schedules and medications, dosage regimen and other medical procedures and length or time period the study. Clinical trial protocol is required to provide in detail information about regulatory Sponsor, information about investigators and sponsor , Funding Sponsor, and their complete details as address and contact numbers ,contact details , Clinical trail protocol gives an idea about the necessity of study and with its background, such information can be provided in separate document in referenced in the protocol. Main objective of the clinical trial protocol is the protection of subjects participating in a clinical trial.
More over the content and the format of a clinical trail protocol for trials sponsored by a pharmaceutical and Biotechnology Company in United States of America, European union, Japan is standardized so as to follow regulations in good clinical practices guidelines issued by ICH. (International conference on harmonization of technical requirements for registration of pharmaceuticals for human use) authorizes in Canada and Australia responsible for regulation of pharmaceuticals and drugs also follow ICH guidelines.

Having a protocol in place for a clinical trial enables investigator to have a common reference document for the researchers' responsibilities and duties during the trial and it also facilitate them to conduct trails at many locations (multi center trial), with complete similarity at all places and at the end of study data is collected from all study centers and combines for final evaluations.


You may also like

What is antibiotic resistance , how antibiotic resistance is developed , How antibiotic resistance is counteracted

Why Betalactam Antibiotics require separate manufacturing aria in a pharmaceutical manufacturing company?

What is Nanotechnology, its applications in medicine and pharmaceuticals, drug developments ?

Novel Drugs: Cancer Chemotherapy Using Nanoparticles developed with Nanotechnology May Reduce Harmful Side Effects of Antineoplastic Agents.

Protein which is responsible for cancer spread discovered . An antisense RNA treatment or a drug could be designed to treat cancer efficiently and safely.

What is antisense RNA ?

What is PEGylation technology ?

What is a prion , What is Mad Cow Disease , Creutzfeldt–Jakob disease ?

US FDA limits dosage of acetaminophen to 325 mg per unit dosage form,Requires boxed warning on lables

What is an Isolator in pharmaceutical manufacturing

What is a Laminar Air Flow Cabinet?

21 cfr part 11 FDA guidelines .

Validation In pharmaceutical

Media Fill Run To Ensure Sterility In Sterile Dosage Forms

What is HEPA filter?

Clean Room Classification

Pharmaceutical Process validation

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org