Custom Search

Sunday, November 7, 2010

HOW ARE US FDA CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED

PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDAHOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?



Upon arrival at the clinical investigator study site, the US FDA investigator displays his/her FDA credentials and issue a completed Form FDA 482 (Notice of Inspection) to the clinical investigator or appropriate study staff. FDA is authorized at reasonable times to access, inspect, and copy any required records related to the clinical investigation. See section 704 of the Federal Food, Drug, and Cosmetic Act (21 USC 374), 21 CFR 312.68, and 21 CFR 812.145.
During an inspection at the site of a clinical investigator, the FDA investigator typically verifies compliance with the regulations governing the use of investigational products and human subject protections at 21 CFR parts 50, 56, 312, and/or 812, by inspecting records and talking to individuals involved in the conduct of the study to ascertain:
• who performed various aspects of the protocol for the study (e.g., who verified inclusion and exclusion criteria, who obtained informed consent, who collected adverse event data);
whether the IRB approved the protocol, informed consent form, and any amendments to the protocol prior to implementation;
whether the clinical investigator and study staff adhered to the sponsor’s protocol and investigational plan and whether protocol deviations were documented and reported appropriately;
whether informed consent documents were signed by the subject or the subjects’ legally-authorized representative prior to entry in the study (i.e., performance of any study-related procedures);

• whether authority to conduct aspects of the study was delegated, and if so, how the conduct of the study was supervised by the clinical investigator;
• where specific aspects of the investigation were performed;
• how the study data were obtained and where the study data were recorded;
• accountability for the investigational product, including shipping records and disposition of unused investigational product;
whether the clinical investigator disclosed information regarding his financial interests to the sponsor and/or interests of any subinvestigator(s), spouse(s) and dependent children;

• the monitor’s communications with the clinical investigator;
• the monitor’s evaluations of the progress of the investigation; and
corrective actions in response to previous FDA inspections, if any, and regulatory correspondence or sponsor and/or monitor correspondence.

The FDA investigator also may audit the study data by comparing the data filed with the agency or the sponsor, if available, with records related to the clinical investigation. Such records may include the case report forms and supporting source documentation including signed and dated consent forms and medical records including, for example, progress notes of the physician, the subject’s hospital chart(s), and the nurses’ notes. These records may be in hard copy and/or an electronic format. For electronic records and/or electronic signatures, the FDA investigator may gather information to determine whether 21 CFR part 11 requirements have been met FDA may also examine subjects’ medical records that are part of the clinical investigation and predate the study to verify whether the condition under study was in fact diagnosed, the study eligibility criteria were met, and whether the subject received any potentially interfering medication prohibited by the protocol. The FDA investigator may also review subjects’ records covering a period after completion of study-related activities to determine if there was proper follow-up as outlined in the protocol, and if the clinical investigator submitted all reportable adverse events (including all clinical signs and symptoms). See 21 CFR 312.64(b) and 812.150(a).

Requiremets US FDA Inspections of Clinical Investigators of Clinical Trials

US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA

REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS ?

=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.

=====================================================================================================
You may also like following articles

What is a Site Master file of a pharmaceutical company

What is Generic Drug

What is Referance Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents

Why a drug is bound to protein, What is protein binding?  What is drug absorption , distribution ?

Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions


Antibiotic Definition and classification


Antibiotic resitance and Antibiotic resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production

TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates


Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry

Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company

1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation

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