Once the funding for a clinical trial has been secured, careful planning is required to ensure effective conduct of the trial. The sponsor of a trial is responsible for the overall set-up and conduct. To ensure rigour and compliance with all applicable guidelines, key processes need to be developed and appropriately documented before the trial can actually begin. Some of these documents (including Essential Documents), are also a pre-requisite for seeking regulatory approval if required. These documents help in planning smooth implementation of all trial related activities, and ultimately ensure safety of trial participants and data credibility.
Following are some of the key regulations, principles and guidelines that one should comply with, and refer to for planning and conducting clinical trials in India:
- The Drugs and Cosmetic Acts and Rules, 1945, as amended up to the 31st of December 2016, Ministry of Health and Family Welfare, Government of India, available online.
- New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 01.04.2019).
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online.
- National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research, 2017, available online.
- ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9th November 2016, available online.
- Good Clinical Laboratory Practices (GCLP), Indian Council of Medical Research, 2008, available online.
- S. Food & Drug Administration, Good Laboratory Practices for Conducting Nonclinical Laboratory Studies, 2005, 21CFR58, available online (last accessed on 26.02.2019).
- Clinical Data Interchange Standards Consortium (CDISC): CDISC Foundational Standards are a complete suite of standards that support medical research of any type, from protocol through analysis and reporting of results. CDISC also focuses on core principles for defining data standards and models for study data tabulation. It is recommended that the CDISC website and published standards and models are referred.
- National Accreditation Board for Testing and Calibration Laboratories (NABL) is a Constituent Board of Quality Council of India. The website provides information on accredited laboratories in India and reference documents that are useful.
The following sections of the toolkit cover the steps in in setting up a trial. It is important to note that, these steps or processes are not necessarily sequential – they should be carried out in parallel.
The attached file can be customised for use as a Gantt Chart or a checklist for trial set-up.