GAP Analysis & Readiness Assessment: A comprehensive evaluation of the current processes, documentation, and infrastructure of the Ethics Committee (EC) against NABH standards. Identifying gaps in ethical practices, participant protection protocols, and documentation processes, followed by a structured improvement plan for readiness.

Ethical Guidelines & Compliance: Assisting the Ethics Committee in establishing and maintaining protocols in compliance with national and international ethical guidelines, such as GCP (Good Clinical Practice), ICH E6, and national regulatory standards. Ensuring adherence to ethical standards in clinical trial design, approval, and participant consent.

Informed Consent & Participant Rights: Guiding the EC in developing standardized informed consent procedures that ensure transparency, participant understanding, and voluntary consent. Ensuring all trial participants' rights, confidentiality, and safety are prioritized.

Document Management & Record Keeping: Assisting in developing and organizing documentation related to ethical review, participant consent, trial protocols, and monitoring reports. Ensuring that records are complete, securely stored, and accessible for audit purposes, in compliance with NABH standards.

Risk Management & Safety Protocols: Supporting the development and implementation of risk management strategies to assess and mitigate risks to trial participants. Providing guidance on safety reporting, adverse event monitoring, and ensuring timely communication of safety information to stakeholders.

Training & Competency Development for EC Members: Providing structured training programs for Ethics Committee members on topics such as clinical trial regulations, ethical decision-making, participant safety, and confidentiality. Regular training updates ensure compliance with evolving ethical and regulatory standards.

Independent Review & Monitoring Procedures: Assisting in setting up independent review processes for trial protocols, ensuring unbiased and thorough assessments of the ethical implications of clinical research. Ensuring that the trial protocol includes adequate provisions for participant monitoring and follow-up.

Conflict of Interest Management: Guiding the Ethics Committee in developing policies to identify and manage conflicts of interest among committee members, researchers, and sponsors. Ensuring that all decisions made are in the best interest of trial participants and the integrity of the research.

Audit Preparation & Mock Assessments: Conducting mock audits to assess the EC’s preparedness for NABH accreditation. Identifying gaps in processes and implementing corrective actions to ensure compliance with NABH standards for clinical trials.

Post-Accreditation Support & Monitoring: Providing ongoing support to maintain compliance with NABH standards post-accreditation, including regular reviews, retraining, and assistance with re-accreditation. Continuous support ensures the Ethics Committee remains aligned with evolving regulations and standards in clinical trials.