Declaration of Responsibility and Compliance with Prospective CTRI Registration

I/we (Student and Guide/Overall Trial Coordinator (PI)/Co-PI/Site-PI/Sponsor/Ethics Committee/CRO) hereby declare and affirm that:

• No participant has been enrolled in the clinical trial prior to registration with the Clinical Trials Registry - India (CTRI).
• The Ethics Committee approval submitted is valid, has been obtained within the last one year, and the entire duration of the proposed clinical trial is within the validity period of this approval.
• We accept joint and full responsibility for ensuring prospective CTRI registration, and for the accuracy, authenticity, and completeness of all information and documentation submitted.
• We fully understand that any instance of:
  • False or misleading declaration,
  • Use of forged or expired Ethics Committee or DCGI regulatory documents,
  • Retrospective registration of the trial, or
  • Misrepresentation of trial-related information
  shall constitute a serious breach of CDSCO/DHR/ICMR/WHO guidelines and institutional policies.
• In the event of such non-compliance, we acknowledge and accept that we may be held individually and collectively liable and may be subject to disciplinary action, academic sanctions, withdrawal of Ethics Committee clearance, or legal proceedings as deemed appropriate by the University, Ethics Committee, regulatory authorities, or any competent body.
• CTRI relies solely on the information submitted by investigators, sponsors, and institutions. It assumes no responsibility for the verification of the authenticity of documents. Any clinical trial found to be retrospectively registered, based on invalid or falsified documentation, or conducted beyond the approved duration will be flagged accordingly and may be reported to the appropriate authorities and will lead to freezing of registrants account in CTRI.

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