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Handbook for good clinical research practice (GCP):

Handbook for good clinical research practice (GCP): 2025

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The 'Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation' by the World Health Organization provides comprehensive guidelines for conducting ethical and scientifically sound clinical research involving human subjects. It outlines the principles of GCP, including ethical conduct, informed consent, risk assessment, and the responsibilities of various stakeholders such as sponsors, investigators, and ethics committees. The handbook serves as a reference tool to ensure that clinical trials are conducted in compliance with international standards, protecting the rights and well-being of participants while ensuring data integrity.

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Click ‘Get Form’ to open it in the editor.
Begin by reviewing the Preamble and Introduction sections to understand the context and importance of GCP principles.
Navigate through each principle, such as Ethical Conduct and Protocol Compliance, ensuring you fill in any required fields related to your specific study.
Utilize our platform's commenting feature to add notes or questions about specific sections for later reference.
Once all necessary information is entered, review your entries for accuracy and completeness before saving or sharing the document.

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What are the 12 principles of GCP?

See WHO GCP Principles 1: Ethical Conduct; 2: Protocol; 4: Benefit- Risk Assessment; 5: Review by IEC/IRC; 7: Informed Consent; 8: Con- tinuing Review/Ongoing Benefit-Risk Assessment; 11: Records; 12: Confidentiality/Privacy.

Is ICH E6 GCP mandatory in the US?

Like all ICH guidelines, ICH E6 R3 isnt a binding, mandatory requirement that you have to follow. The US FDA states that an alternative approach may be used and maps out its own GCP touchpoints in FDA 21 CFR Parts 50, 54, 56, 312 and 314.

What are the principles of GCP?

GCP core principles The rights, safety and wellbeing of the trial subjects are the most important considerations and should prevail over interests of science and society. The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

How many GCP principles are there?

There are 13 core principles of ICH-GCP and they are as follows: 1. Clinical trials should be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

What is the main purpose of good clinical practice (GCP)?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.

Is GCP valid for 3 years?

How often do I need to renew it? You will need to check the Standard Operating Procedures (SOPs) of your trust and employing organisation. This will define how often you need to renew your GCP by doing the GCP Refresher course. We recommend refresher training every 2 to 3 years to keep up with best practice.

What is the principle 12 of Ich GCP?

Principle 12: The confidentiality of records that could identify sub- jects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

What are the 12 principles of ethics with examples?

Generally, there are about 12 ethical principles: honesty, fairness, leadership, accountability, integrity, compassion, respect, responsibility, loyalty, respect for the law, transparency, and environmental concerns.

Handbook for good clinical research practice (GCP): 2025

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Got questions?

What are the 12 principles of GCP?

Is ICH E6 GCP mandatory in the US?

What are the principles of GCP?

How many GCP principles are there?

What is the main purpose of good clinical practice (GCP)?

People also ask

Is GCP valid for 3 years?

What is the principle 12 of Ich GCP?

What are the 12 principles of ethics with examples?

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Handbook for good clinical research practice (GCP): 2025

Here's how it works

How to use or fill out Handbook for good clinical research practice (GCP): with DocHub

Complete this form in 5 minutes or less

Got questions?

What are the 12 principles of GCP?

Is ICH E6 GCP mandatory in the US?

What are the principles of GCP?

How many GCP principles are there?

What is the main purpose of good clinical practice (GCP)?

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People also ask

Is GCP valid for 3 years?

What is the principle 12 of Ich GCP?

What are the 12 principles of ethics with examples?

Related links

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