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How long does the ethical approval process typically take?
The review process usually takes several weeks to a few months. Best will be to contact the IEC Secretariat who will be able to guide you better.
The review process usually takes several weeks to a few months. Best will be to contact the IEC Secretariat who will be able to guide you better.
See lessDo I need to seek approval for any changes to my research design after initial approval?
Yes, if you make any changes to your research design, you must inform the ethics committee and seek approval for any amendments. Only administrative changes are allowed. You must consult your Supervisor/Guide and IEC Secretariat to ensure this.
Yes, if you make any changes to your research design, you must inform the ethics committee and seek approval for any amendments. Only administrative changes are allowed. You must consult your Supervisor/Guide and IEC Secretariat to ensure this.
See lessWhat are my responsibilities regarding reporting adverse events?
If any unexpected or harmful events occur during your research, you must report them immediately to the ethics committee within 24 hours.
If any unexpected or harmful events occur during your research, you must report them immediately to the ethics committee within 24 hours.
See lessWhat is CTRI?
: CTRI is the Clinical Trials Registry - India (CTRI) launched on 20th July 2007 is managed by the ICMR-National Institute of Medical Statistics, New Delhi, India. The CTRI ( www.ctri.nic.in) is an online, free and searchable system for the prospective registration of all clinical studies being condRead more
: CTRI is the Clinical Trials Registry – India (CTRI) launched on 20th July 2007 is managed by the ICMR-National Institute of Medical Statistics, New Delhi, India. The CTRI ( http://www.ctri.nic.in) is an online, free and searchable system for the prospective registration of all clinical studies being conducted in India. In addition, the CTRI also registers clinical studies being conducted in countries which do not have a Primary Registry of their own.
See lessWho is responsible for registering a trial?
A responsible Registrant, Trialist or User is authorized to register clinical trials in the CTRI. Registration in the CTRI is needed to gain access to this facility. The "Registrant" for a trial is either the principal investigator (PI) or the primary sponsor, to be decided by an agreement between tRead more
A responsible Registrant, Trialist or User is authorized to register clinical trials in the CTRI. Registration in the CTRI is needed to gain access to this facility. The “Registrant” for a trial is either the principal investigator (PI) or the primary sponsor, to be decided by an agreement between the parties. The primary sponsor is ultimately accountable for ensuring that the trial is properly registered. For multi-center and multi-sponsor trials, it is the lead PI or lead sponsor who should take responsibility for registration.
See lessWhy should trials be registered in the CTRI?
Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.e. the Drugs Controller General (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made it mandatory to register clinical studies in the CTRI.Read more
Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.e. the Drugs Controller General (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made it mandatory to register clinical studies in the CTRI.
See lessIs it mandatory to register my purely observational study?
The CTRI is a facilitator body that provides a platform for registering clinical studies as mandated by the drug licensing authority, ethics committees and journal editors. Further, the WHO advises 'When in doubt, register'. In addition, it may be noted that since 1st April 2018, the CTRI onRead more
The CTRI is a facilitator body that provides a platform for registering clinical studies as mandated by the drug licensing authority, ethics committees and journal editors. Further, the WHO advises ‘When in doubt, register’.
In addition, it may be noted that since 1st April 2018, the CTRI only registers clinical trials prospectively, i.e., before the enrolment of the first patient and hence the decision to register should be made before trial initiation as registration will not be feasible later.
See lessWhat type of clinical studies are registered in the CTRI?
All types of clinical studies, i.e. interventional, observational, bioavailability/bioequivalence and post-marketing studies are registered in the CTRI. In addition it may be noted that clinical studies from traditional medicinal systems as well as clinicalstudies conducted as part of post-graduateRead more
All types of clinical studies, i.e. interventional, observational, bioavailability/bioequivalence and post-marketing studies are registered in the CTRI. In addition it may be noted that clinical studies from traditional medicinal systems as well as clinicalstudies conducted as part of post-graduate thesis are also registered in the CTRI.
See less