Definition: Any medicinal product that is being tested or used as a reference in a clinical trial.
An investigational product may be an unlicensed product or a licensed product when used or assembled (formulated or packaged) differently from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.
A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people.
A Non Investigational Medicinal Product (NIMP) is a medicinal product which is not classed as an IMP in a trial, but may be taken by subjects during the trial.
An investigational product is a drug, biological product, device, or placebo being tested or used in a clinical trial.
An Investigational Medicinal Product Dossier (IMPD) contains data on the quality, production and control of the medicinal product being researched. This information concerns the active product, placebo and reference product (if applicable). It also contains a summary of data from all clinical and non-clinical research.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
European Dossier means the necessary documentation for a medical device manufacturer to obtain a CE marking for its product according to the European Medical Device Directory.
CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party's responsibilities and obligations for the clinical trial.
To Be a CRA is a must for anyone wanting to know more about the pharmaceutical industry and the role of a clinical research associate, while To Be a CTA aims to provide ideas, information and guidance to anyone who might be interested in becoming a clinical trial administrator.
Good Laboratory Practice (GLP) regulates the processes and conditions under which clinical and non-clinical research is conducted. GLP also governs how these research facilities should be maintained. Good Clinical Practice (GCP) guidelines are dictated by the International Conference on Harmonization (ICH).
The Clinical Trial Assistant (CTA) is an essential position within a clinical operations team at a pharmaceutical company, a Clinical Research Organization (CRO) or a Clinical Research Unit in a university hospital. The CTA is responsible for project-supporting clinical drug research and development tasks.
Clinical research coordinators work under clinical research managers and are tasked with administering clinical trials. Their primary responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.
Clinical research associate/clinical study monitor (CRA/CSM): Oversees the progress and conduct of the clinical study to ensure the integrity of the data being collected and the safety of the participants, ensures the clinical study site complies with the protocol, monitors the study sites and documents findings on ...
A Clinical Trial Application (CTA) is a submission to the competent National Regulatory Authority(ies) for obtaining authorization to conduct a clinical trial in a specific country. It is an application with necessary information on investigational medicinal products.
What is the difference between IND and CTA submissions? Preclinical studies are essential for the development of all drug candidates. In general, CTAs contain fewer study documents than INDs, and hence require less preparation time.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health ( ...
The IMPD is the main document of the CTA in the EU used for obtaining the authorization to conduct a clinical trial with an IMP.
In the United States, the initial submission to permit use of an investigational drug in a clinical setting is called an investigational new drug (IND) application. In the European Union, this documentation is submitted within a clinical trial application (CTA).
The Investigational Medicinal Product Dossier (IMPD) is a central piece of Investigational Medicinal Product (IMP) related documents required for approval of clinical trials by the competent authorities in the EU.
IMPDs are submitted as part of the Clinical Trial Application Dossier, as the basis for approval of clinical trials by competent regulatory authorities within the European Union. Investigational New Drug (IND) applications are the equivalent in the United States.