Clinical Trial Registration Process in Nepal

Introduction

Nepal Health Research Council (NHRC) initiated an online platform Nepal Clinical Trial Registry (NPCTR) to register Clinical Trials in Nepal.

The NPCTR is an online registry for clinical trials of human subjects conducted in Nepal and oversees within It is the voluntary platform, not-for-profit clinical trials registry providing free access to researchers to ensure access in line with the WHO/ICTRP registry network.

The Protocol along with individual clinical trial participant-level (IPD) data will be recorded in the NPCTR platform. All types of clinical studies; interventional, observational, bioavailability/bioequivalence and post marketing studies are registered in this platform. This registry is monitored by NHRC, MoHP and WHO/ICTRP.

Requirements to register trials

• Trail Protocol (Proposal)
• Approved ethical clearance letter
• Agreement letter from study site
• Researcher profile

Target researchers

• Worldwide researchers
• Industry/Company [Mainly focused for Nepali Researchers]

Requirement of Clinical Trial Registration in Nepal

WHO/ICTRP mandate to establish a trial registry at the convenience places for researchers. [Note: Drug Act 2035 mentioned any person who intends to carry out a clinical trial of any new drug shall obtain a license from the department, as prescribed, for such trial. For conducting the clinical trial in Nepal, medicine registration guidance (Issued under Drug Registration Regulation 2038) section 2.18 mentions an approval of Nepal Health Research Council (NHRC) and other government-approved agencies are required.]

Process

• Go through the online portal (npctr.nhrc.gov.np).
• Fulfill all data set
• Will get unique identification number. Researcher will get the NPCTR number and that number will be equivalent to WHO/ICTRP.

Fee

• It is not a profitable platform.
• All the trails will be registered free of cost.

ACCREDITATION

The NPCTR will be officially recognized as a primary registry of WHO International Clinical Trials Registry Platform (ICTRP) network https://www.who.int/ictrp/network/primary/en/. It will be the primary registry and number 19 worldwide.

Related

• Nepal Health Research Council (NHRC)
• NepMed, Nepal MEDLINE (Medical Literature Analysis and Retrieval System Online)
• List of Approved Institutional Review Committee (IRC), NHRC
• NHRC approval processing fee (Effective from March 7, 2018)
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