Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

India outlines 14 "essential elements" of informed consent for drug trials

This article was originally published in Scrip

Executive Summary

Companies that are sponsors of clinical trials undertaken in India will have to abide be new requirements for informed consent documents. India's Central Drugs Standard Control Organization has laid out 14 "essential elements" that must be included in such documents used to enrol subjects in a drug trial.

You may also be interested in...



WHO To Clean Up Data Integrity Failings

The World Health Organization has proposed changes to its 2016 guideline on data integrity requirements to provide streamlined information to sponsors and to take account of experience gained to date. 

EU Regulators Prioritize Nitrosamine Evaluations Deadline

EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.

Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators

EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.

Topics

UsernamePublicRestriction

Register

SC018508

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel