Clinical Trial Registry of India (CTRI)

Clinical Trial Registry of India (CTRI)

1. Definition & overview

• The Clinical Trials Registry – India (CTRI) is a free, online, publicly accessible record system for the prospective registration of clinical trials and related studies conducted in India (ctri.nic.in) [CTRI].
• CTRI is hosted, designed, developed and maintained by the ICMR–National Institute for Research in Digital Health (NIRDH, formerly the National Institute of Medical Statistics, NIMS), a division of the Indian Council of Medical Research (ICMR) [CTRI].
• It was launched on 20 July 2007 as a voluntary registry; registration in CTRI was made mandatory by the Drugs Controller General (India) [DCGI] with effect from 15 June 2009 [CTRI].
• A clinical trials registry is a publicly accessible database that records, at minimum, a defined dataset of administrative and scientific information about a clinical trial, ideally before the trial begins (prospectively) — i.e. before the first participant is enrolled [WHO-ICTRP].
• The CTRI's stated mission is to ensure that all clinical trials conducted in India are prospectively registered with full disclosure of the WHO-mandated trial-registration dataset before enrolment of the first participant [CTRI].
• Scope of registrable studies is broad: interventional trials of drugs, vaccines, devices, surgical procedures, behavioural and educational interventions; bioavailability/bioequivalence (BA/BE) studies; observational/epidemiological studies; and post-marketing surveillance studies — registration of these in CTRI is encouraged or, in specified cases, mandated [CTRI; NDCT Rules 2019].
• Conceptual anchor: the regulation of medicines is intended to provide "an objective, rigorous and transparent assessment of efficacy, safety and quality in order to protect and promote public health" — trial registries are a key instrument of this transparency (B&B 12e Ch.6, p.69–70).
• In the broader process, therapeutic evaluation is divided into pre-registration and post-registration phases (here "registration" = marketing-authorisation/licensing of the drug, a distinct sense from trial registration), and "in an age of transparency, regulation and publication are key interpretative factors in the analysis of trial results" (B&B 12e Ch.4, p.43, Table 4.1).
  • ⚠ Terminology caution: in pharmacology textbooks "pre-/post-registration" usually refers to product registration/licensing; the CTRI sense of "registration" is trial registration in a registry — a separate concept. Do not conflate.