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Question: According to EU guidance on the content of the Trial Master File and archival, where should Certificates of Analysis (CoA) for the first batch of IMP is filed?

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New Chemical Entity (NCE)

A drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. An NCE is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease. Synthesis of an NCE is the first step in the process of drug development.

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In this website you will find Good Clinical Practice (GCP) related information for the Clinical Research Industry professionals on request. The GCP HelpDesk is designed to provide information for clinical research professionals with questions regarding handling, conducting and managing clinical research as per GCP, FDA and other Regulations. This HelpDesk is aimed to provide transparency from resources and expertise in the field of Clinical Reasearch with the recent developments and changes in the guidelines for clinical research professionals. The GCP HelpDesk is a searchable website that will match the question with solution by industry experts and other dedicated sites to a specific area. Both simple and complicated questions are welcomed by the GCP HelpDesk and we will provide you the answer, if not hope to point you to the one who can. The GCP HelpDesk service is completely free and you can search for required information or by sending an email to GCP Help Desk by including your full name, email address, valid phone number, and a brief description of the problem. We will get back to you through email.

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Human embryonic stem cell therapy is being tried on a human for the first time in a new clinical trial. This is the first clinical trial of its kind in the world. The first patient is reported as a patient in ...

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The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The new rule requires that certain safety information that previously had not been required ...

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Opinion Poll

What do you think, which of following is the major factor at site likely to impact data Quality?

	Compliance (Protocol, Governing SOPs & applicable regulatory requirements)
	Data accuracy, completeness and credibility
	Patient pool
	Staff resource and management
	Training and ongoing guidance
	Record retention/Archival
	Medical practices

This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.