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GCP 13 Principles

The document outlines 13 principles of Good Clinical Practice (GCP) that aim to protect the rights, safety, and well-being of human subjects in clinical trials. The principles state that clinical trials must follow ethical guidelines, have anticipated benefits that outweigh risks for subjects, obtain informed consent from subjects, ensure trial staff are qualified, and implement quality control systems to ensure accurate reporting and protection of confidential data. Medical decisions for subjects must be made by qualified physicians in compliance with approved study protocols.

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401 views

GCP 13 Principles

The document outlines 13 principles of Good Clinical Practice (GCP) that aim to protect the rights, safety, and well-being of human subjects in clinical trials. The principles state that clinical trials must follow ethical guidelines, have anticipated benefits that outweigh risks for subjects, obtain informed consent from subjects, ensure trial staff are qualified, and implement quality control systems to ensure accurate reporting and protection of confidential data. Medical decisions for subjects must be made by qualified physicians in compliance with approved study protocols.

Uploaded by

shaik_firoz
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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GCP - 13 Principles

 Ethics
Clinical trials should be conducted in accordance with the ethical principles that have their
origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable
regulatory requirement(s).

 Trial risk vs trial benefit


Before a trial is initiated, foreseeable risks and inconveniences should be weighed
against the anticipated benefit for the individual trial subject and society. A trial should be
initiated and continued only if the anticipated benefits justify the risks.

 Trial participants
The rights, safety, and well-being of the trial subjects are the most important
considerations and should prevail over interests of science and society.

 Information on the Medicinal Product


The available non-clinical and clinical information on an Investigational Product should be
adequate to support the proposed clinical trial.

 Good quality trials


Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

 Compliance with the study protocol


A trial should be conducted in compliance with the protocol that has received prior
institutional review board (IRB)/independent ethics committee (IEC) approval/favourable
opinion.

 Medical decisions
The medical care given to, and medical decisions made on behalf of, subjects should
always be the responsibility of a qualified physician or, when appropriate, of a qualified
dentist.

 Trial staff
Each individual involved in conducting a trial should be qualified by education, training,
and experience to perform his or her respective task(s).

 Informed consent
Freely given informed consent should be obtained from every subject prior to clinical trial
participation.

 Clinical trial data


All clinical trial information should be recorded, handled, and stored in a way that allows
its accurate reporting, interpretation and verification.

 Confidentiality
The confidentiality of records that could identify subjects should be protected, respecting
the privacy and confidentiality rules in accordance with the applicable regulatory
requirement(s).

 Good Manufacturing Practice


Investigational products should be manufactured, handled, and stored in accordance with
applicable good manufacturing practice (GMP). They should be used in accordance with
the approved protocol.

 Quality assurance
Systems with procedures that assure the quality of every aspect of the trial should be
implemented.

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