What is Clinical Trial Application?
The term clinical trial application gives us a very clear understanding about the investigational medicinal products and planned trial. It also enables regulatory authorities to examine and asses the acceptability of conducting the study. The assessment done by the health authorities cover the benefit risk ration, investigational medicinal product properties, the quality information provided by the subject of the trial. The suitability of clinical sites and investigators is also considered.
If you are looking for the information regarding genetically-modified organisms than that is available in EPA (European Protection Agency). Clinical Trials in Ireland in governed by European Communities (Clinical trials on medical products and human use) Regulations, 2004 Sl no 190 of 2004 amendments.
Role of European Union
All these regulations got inherited in the Irish law of provision of council Directive 2001/20/EC on the approximation of laws & regulations of administrative provisions of the member states relating the good practices implementation of good conduct of clinical trials and clinical practices on human use.
The regulations by Control of Clinical Trials Acts 1987 – 1990 for clinical trials have allowed using medicinal products are superseded. The definition itself covers the regulations on studies on clinical. Pharmacodynamics, pharmacological or pharmacokinetics effects and studies to identify adverse reactions to medicinal product investigation. Which would be phase one to phase 4 studies.
There is a prior authorization from CA (competent authority) and EC (ethics committee) before the trial is give to a state that is member. There is a possibility of other bodies/committees may het involved, depending upon the study and concerned country.
How Are Clinical Trials Conducted
If you are looking to get your clinical trial approved, you need to submit you clinical trial application to the regulatory bodies know as CA as mentioned above. A REC( Research ethics committee may also review it on the basis of clinical research protocol; and will give a positive or negative opinion. They will make sure that the drug which has come for the clinical trial approval respects the dignity, safety, rights and well being of people who will use this drug,
In order to make sure that everything is going as per the company standard, all of the clinical trial protocols majorly are developed in line with the “Declaration of Helenski” set of of ethical standards specially made for research that involves human beings or human material. Since its inception in 1964 by World Medical Association in has been revised many times.
All the clinical trials on the medicines are conducted in EU are in compliance with all the regulations, guidelines and directives mentioned above. GOOD CLINICAL PRACTICE is the standard that every clinical trial has to meet, it is also mentioned in guideline by the ICH-GCP (international council for harmonization of technical requirements for pharmaceuticals for human user). This is an international standard of quality that must be applied in all members of state. The expectations and responsibilities off all participants in the clinical trials conduct, including monitors, sponsors, investigators and ethics committee. GCP cover aspects of reporting and monitoring of a clinical trial data, which had been agreed in the ICH process.
Tag:clinical data management, clinical research associate, clinical research associate training, clinical research coordinator, clinical trial application, clinical trial protocol, clinical trial regulation, clinical trial research, clinical trials training, phases of clinical trials, worldwide clinical trials