Ethics
Share
Hello,
Sign up to join our community!
Sign up to join our community!
Please sign in to your account!
Lost your password? Please enter your email address. You will receive a link and will create a new password via email.
Please briefly explain why you feel this question should be reported.
Please briefly explain why you feel this answer should be reported.
Please briefly explain why you feel this user should be reported.
Who 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 lessHow do I ensure confidentiality in my research?
Ensure you take a training on ethics in research and GCP (Good Clinical Practice). You should protect participant identities by using codes instead of names, storing data securely, and anonymizing information where possible.
Ensure you take a training on ethics in research and GCP (Good Clinical Practice). You should protect participant identities by using codes instead of names, storing data securely, and anonymizing information where possible.
See lessWhat is informed consent?
Informed consent is a process where participants are provided with detailed information about the research, including potential risks and benefits, and are given the opportunity to freely choose whether to participate.
Informed consent is a process where participants are provided with detailed information about the research, including potential risks and benefits, and are given the opportunity to freely choose whether to participate.
See lessWhat is ethical approval?
Ethical approval is a process where a research ethics committee at KAHER reviews your research proposal to ensure it adheres to ethical principles, protecting the rights and welfare of participants involved in your study.
Ethical approval is a process where a research ethics committee at KAHER reviews your research proposal to ensure it adheres to ethical principles, protecting the rights and welfare of participants involved in your study.
See lessWhy do I need ethical approval for my research?
It's mandatory for any research involving human participants to obtain ethical approval, regardless of the study's nature, to safeguard participant’s right, safety, and well-being from potential harm and uphold ethical research standards.
It’s mandatory for any research involving human participants to obtain ethical approval, regardless of the study’s nature, to safeguard participant’s right, safety, and well-being from potential harm and uphold ethical research standards.
See lessWho is responsible for obtaining ethical approval?
As the primary researcher, you are responsible for submitting your research proposal to the relevant ethics committee and ensuring all necessary approvals are obtained before commencing your study.
As the primary researcher, you are responsible for submitting your research proposal to the relevant ethics committee and ensuring all necessary approvals are obtained before commencing your study.
See lessWhere can I find the application form for ethical approval?
Contact your university's research ethics committee or the appropriate department to access the application form and guidelines. Visit https://kaher.edu.in/ for more info. You can also ask your Supervisor/Guide.
Contact your university’s research ethics committee or the appropriate department to access the application form and guidelines. Visit https://kaher.edu.in/ for more info. You can also ask your Supervisor/Guide.
See less