FDA inspections of clinical sites is something wrong with a clinical site is not an accusation , but it is still not prepared properly , especially if it can be a scary experience .
FDA inspection of the clinical data management / integrity and regulatory compliance are used to ensure that a quality assurance process. Here we make it available to your site and show you how your nerves .
- The most common FDA inspection of a New Drug Application ( NDA ) submission prompted by the ‘ routine inspection ‘ , either . NDA is the ideal candidate for a routine inspection, the majority of patients enrolled in clinical trials are critical in the clinical site .
- ‘ Cause inspection ‘ is not common , and the FDA receives a report of , or suspicious behavior , will become aware of the request . Here are some reasons why such an audit might bring :
_ For many clinical trials
_ Outside Your Specialization for carrying out clinical research
_ Much better performance , fewer adverse effects , or different from other sites in the same drug study reports the results of laboratory
Number of patients with a particular disease state can stand for setting _ Having access
Regulations , protocols , or to sponsor a patient or _ complaints in regards to human rights violations
May trigger the recall of a product , customer complaints
How it all started
It all started with a phone call . The FDA does not interrupt the activity of both parties and that the site is agreed between the inspection program that will call at a time . However , they will only give you between 5 and 14 days’ notice , and the site will spend about 2 to 3 days .
They can give you good advice to the sponsor and the FDA on the clinical site is not sponsored by , because , to be visited and the tour can be found , and should promptly contact the sponsor of the study are entitled to ask what was going to study .
Before the inspection , the documents gathered for the study in question :
- The investigator ‘s brochure and IND Safety Reports
FDA Form 1572 with accompanying CVs
Including documentation and final report to the sponsor and IRB Approval – IRB correspondence ,
Informed Consent Form – IRB approved
- IRB approved advertisements
Investigating the exception of contracts and financial data , research – Correspondence
- Monitor sign -in log
- Laboratory certification documents
- Drug accountability records
- Each subject signed the informed consent
Make sure they are properly prepared , like pharmacy or lab support areas – assessment . FDA may tour the facility
Be prepared to answer these questions :
- Where is this study ?
- What special equipment is used ?
- Assistance in doing the study ?
- Each person had a specific responsibility ?
- Sponsor of the monitoring methodology and description of your interaction with the monitor .
- You receive the drug delivery , or for the account is returned to the subject ? All drugs have to sponsor ?
Training your staff to anticipate FDA . You are not a professional , and the information they provide on request , except to show the way you should answer the question .
You do not want an unauthorized person checking your files , because firstly , check his ID . Inspector Inspection ( FDA Form 482 ) must be filled in and handed it to the notice .
1.The Inspector will begin by determining the nature of the conduct of the study investigator . He took advantage of travel and talk to everyone who might want to study .
His intention is to collect information on where and how certain procedures are performed , where , and the drug store and is responsible for the investigator’s authority to establish the level of delegation .
These things usually are checked :
- Contact with the initial submission of documents IRB,, adverse event reporting , and the ability to progress reports
- Totality of the receipt , storage , administration , and accountability documents for the test article ( drug , device , etc. )
- Compliance with study protocol , and each deviation / amendment with IRB approval documentation and sponsor
Informed consent process – aptness
IRB and the timely and full reporting of adverse events to the sponsor
With record retention requirements and the compliance of the investigator during the study trial immediate access to the records of the
Sponsor the site and contact – wide monitoring
2.The inspector to audit the data . He submitted it to the FDA to support the medical chart and compare data with source documents will .
He was the subject of medical condition under treatment and the elimination of certain medications during the study period did not let him participate , subject to review of data from before and after .
Complete audit 3.After, the visitor will meet with the investigator to talk about the results . You will receive a copy of any inconsistency, the FDA Form 483 will be registered .
An inspector will be sent to the FDA for evaluation 4 Establishment Inspection Report (EIR) will write . After the evaluation is completed , you will receive a letter .
This message may be displayed in one of three situations :
- It is significant that the inspection was done and nothing was found that could recognize .
- It could be a list of deficiencies found during the inspection , but may point out that no response is required . However , it visited the site in view of the future of this important work on the deficit .
- It could point out serious negative discovery . Site and the information is at risk , and what steps you should take to resolve the situation needs to be answered promptly clarify .
Pharmaceutical companies have too much to lose , because you get the help of a sponsor , and guidance and support , please contact your pharmaceutical consultant .
If you do not respond properly , you could be banned from performing in other studies ; Your research data , or even the entire marketing application may be rejected ; And you may even be facing criminal charges .