International Clinical Trial Regulations: WHO, ICH, FDA And ClinRegs Database

FavoriteLoadingAdd to favorites

WHO defines clinical trial as “A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”

Important international organizations and guidelines concerned with clinical trials are WHO, ICH and FDA Guidance . NIH ClinRegs is global information database of 20 countries.

WHO And Clinical Trials

WHO does not maintain its own registry. As each country has its own requirements for clinical trials research it is possible that single trials could be included on more than one registry.

WHO’s International Clinical Trials Registry Platform (ICTRP) links clinical trials registers globally in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others.

The ICTRP is a global initiative that aims to make information about all clinical trials involving humans publicly available. It also aims to:

  • improve the comprehensiveness, completeness and accuracy of registered clinical trial data;
  • communicate and raise awareness of the need to register clinical trials;
  • ensure the accessibility of registered data;
  • build capacity for clinical trial registration;
  • encourage the utilization of registered data;
  • and ensure the sustainability of the ICTRP.

Who also allocates universal trial number (UTN) .

The aim of the Universal Trial Number (UTN) is to facilitate the unambiguous identification of clinical trials. The UTN is not a registration number.

The UTN is a number that should be obtained early in the history of the trial. The UTN should:

  • become permanently attached to the trial
  • be used whenever information about the trial is communicated
  • become part of the trial’s identity
  • be documented in the trial protocol
  • be submitted every time the trial is registered

You can visit WHO questions and answers section of clinical trials Here:

WHO Clinical Trials Q & A

You can visit WHO ICTRP and search portal here:

WHO ICTRP

Process of Obtaining WHO UTN Here:

WHO UTN Process

ICH Clinical Trial Guidelines

The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.   The Good Clinical Practice  E6(R2) is very significant.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).

This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.

View ICH Clinical Trial Guidelines Here

FDA Draft Guidance On Clinical Trials

FDA document provides guidance to industry on a risk-based approach to monitoring of investigational studies of human drug and biological products, medical devices, and combinations thereof.

This guidance expands on FDA’s guidance for industry “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” (RBM guidance) by providing clarifications and additional guidance to facilitate and encourage sponsors’ implementation of risk-based monitoring.

FDA’s experiences since the RBM guidance was finalized in 2013 suggest that additional guidance would be beneficial regarding FDA’s recommendations for planning a monitoring approach, developing the content of monitoring plans, and addressing and communicating monitoring results.

The questions and answers in this guidance are intended to provide more detailed guidance to assist sponsors in planning and conducting risk-based monitoring.

View FDA Clinical Trial Guidance Here

NIH ClinRegs Global database

NIH has expanded ClinRegs, its free, online database of international clinical trial regulations to include information from 20 countries. You can find clinical trial regulations of countries like USA, UK, Canada, Mexico, Brazil, India, Australia, China, Peru, South Africa and more.,  Here you can access clinical trial regulations on fingertips directly. The site also now offers real-time updates of regulatory changes to its email subscribers.

It was launched in 2014 by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).  The resource includes listings of regulatory authority, ethics committee, clinical trial lifecycle and sponsorship. It also provides regulatory authority contact information, and estimated application review and approval times.

NIH ClinRegs Global database for 20 countries can be Accessed here.

You May Also Like:

Compilation Of International GMP and cGMP Guidelines In Pharmaceuticals

Leave a Comment

Your email address will not be published. Required fields are marked *