“Who is responsible for registering a clinical trial in CTRI—principal investigator, sponsor, or institution—and what are the key steps in the registration process?”
Research Mitra Latest Questions
“What is the Clinical Trials Registry – India (CTRI), and how does it facilitate the registration, transparency, and ethical oversight of clinical trials in India?”
“What are a researcher’s responsibilities in reporting adverse events, including timelines, documentation, and communication with the ethics committee and relevant authorities?”
“Is additional ethical approval required for modifications to the research design after initial approval, and what is the process for submitting amendments to the ethics committee?”
“What is the usual timeline for obtaining ethical approval, and what factors influence the duration, such as the complexity of the study, review frequency of the ethics committee, and the need for revisions or resubmissions?”
“What are the possible reasons for the rejection of an ethical approval application, and what steps can researchers take to address the concerns raised? Can the application be revised and resubmitted, and if so, what is the typical process for ...
“Who is responsible for reviewing ethical approval applications—an institutional review board (IRB), ethics committee, or regulatory body—and what criteria do they assess?”
“How can researchers protect participant confidentiality through data anonymization, secure storage, restricted access, and ethical handling of sensitive information?”
“What is informed consent, and how does it ensure that participants voluntarily agree to take part in research with a full understanding of risks, benefits, and their rights?”