With effect from 1st April 2018, registration
of clinical trials only prospectively as per the new rule of The Clinical Trials Registry of India
(CTRI). CTRI was accepting clinical trial registration which were ongoing and
completed till now but the new rule will make it mandatory to register a
clinical trial before the enrollment of first patient in the study . If the trials
are registered after the study or during the study the study will be marked as Trial
Registered Retrospectively which cannot be altered or changed later. Currently
many publications or journals are accepting publication which are registered
prospectively only. This also have made Indian Council of Medical Research
(ICMR),who is managing the CTRI to take this decision.ICMR started CTRI in 2007
as free clincal trial registry which was made mandatory by Drugs Controller
General of India (DCGI) during 2009.
As per CTRI notification in their website from
1st April 2018,no new submission of any ongoing/closed to recruitment/completed
trials will not be permitted. But due to
the unprecedented number of such trial submissions in the last few days, the
CTRI will process and register these trials until 31st May 2018. Registrants
are requested to proactively cooperate with CTRI regarding requests for trial
modifications and expedite trial verification. The trials where
queries/reminders and verification emails have been sent three or more times
and responses from registrants are not received OR trials are resubmitted
without any modifications will be deleted.
For more details: http://ctri.nic.in/Clinicaltrials/alert.php
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