Reviewing Clinical Trials: A Guide For The Ethics Committee
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What is a Clinical Trial Authority?
A Clinical Trial Authority is an organisation that oversees the clinical research in a country or area, in contrast to a National Regulatory Authority, which might oversee multiple regulatory processes that span product development, including both clinical trial approval and market authorization.
As a result, there may or may not be a distinction between regulatory authorities and “clinical trial authority” in each country. In India, for example, these are separate: the Indian Council of Medical Research (an independent body from the regulatory authority) has influence in clinical trials. In other countries there may be one or multiple bodies which oversee clinical research.
It’s important to check the authorities involved for each country in your research. The Global Health Regulatory Requirements Database, a Global Health Network member site, is a tool that can be used to learn about country-level regulatory requirements. The database contains consolidated access to country-level regulatory requirements in Africa, Asia, and Latin America. In addition to an overview of clinical trial requirements, the database contains a description of ethics review processes and contact information for NRA representatives.
Regulatory approvals submission
Prior to initiating a clinical trial, researchers must obtain approval from national regulatory authorities (NRAs) and ethics committees to conduct clinical trials. NRAs are responsible for ensuring that clinical trials are scientifically sound, that they will result in data that will support regulatory decision making, and that the rights and safety of clinical trial participants are protected. All studies also must undergo ethics approval which, depending on the country and nature of the study, is granted by national and institutional ethics committees.
Regulatory approval pathways, including the order in which approvals need to be granted by ethics committees and NRAs, vary among countries and products. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) lists the following recommended components of clinical trial protocols in the Guideline for Good Clinical Practice E6(R1):
- General information
- Background information
- Trial Objectives and Purpose
- Trial Design
- Selection and Withdrawal of Subjects
- Treatment of Subjects
- Assessment of Efficacy
- Assessment of Safety
- Statistics
- Direct Access to Source Data/Documents
- Quality Control and Quality Assurance
- Ethics
- Data Handling and Recordkeeping
- Financing and Insurance
- Publication Policy
- Supplements
Given that not all countries follow ICH guidelines and that guidelines vary by country, it is important to identify country-level requirements to inform regulatory planning. The Global Health Regulatory Requirements Database, a Global Health Network member site, is a tool that can be used to learn about country-level regulatory requirements. The database contains consolidated access to country-level regulatory requirements in Africa, Asia, and Latin America. In addition to an overview of clinical trial requirements, the database contains a description of ethics review processes and contact information for NRA representatives.
A useful resource for this stage is the Regulatory Database http://regulatory.ghtcoalition.org/
Global Health Reviewers (www.globalhealthreviewers.org) is the arae of the network which supports those reviewing protocols in ethics committees and IRBs. On the site you will find free and open access pragmatic guidance on how to review different types of protocols, as well as up to date news and guidelines.
The Global Health Regulatory Requirements Database is designed to help researchers and regulatory affairs professionals access the information they need to develop effective strategies for gaining approval to conduct clinical trials and market products. The database provides high-level information on regulatory requirements, timelines, costs, and other basic information required to create product development plans for new tools. http://regulatory.ghtcoalition.org/
Print all informationThis article is part of the network’s archive of useful research information. This article is closed to new comments due to inactivity. We welcome new content which can be done ...
This article is part of the network’s archive of useful research information. This article is closed to new comments due to inactivity. We welcome new content which can be done ...
Regulatory approvals submission
You will need to seek approvals from the various regulatory authorities that govern clinical trials in your country and institution. This will usually involve gaining clinical trial ...
Regulatory approvals submission
You will need to seek approvals from the various regulatory authorities that govern clinical trials in your country and institution. This will usually involve gaining clinical trial ...
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