Independent Ethics Committee
Independent Ethics Committee
CG Nashik Independent Ethics Committee (CGRSPL)
CG Nashik Independent Ethics Committee
Composition & Governance
Our committee functions independently of institutional, financial, and political influences. In accordance with Schedule VIII / NDCT Rules 2019, our board includes:
- Chairperson
- Member Secretary
- Clinician
- Basic Medical Scientists
- Legal Expert
- Social Scientist
- Lay Person
Scope of the Ethics Committee
Review & Approval
Evaluating clinical trial protocols, Investigator's Brochures (IB), Informed Consent Forms (ICF), Subject Information Sheets (SIS), patient recruitment materials, and budget/insurance agreements etc.
Compliance Oversight
Ensuring research projects strictly comply with the New Drugs and Clinical Trials (NDCT) Rules, 2019, CDSCO Good Clinical Practice (GCP) Guidelines, ICH-GCP, ICMR Ethical Guidelines, and the Declaration of Helsinki.
Safety Monitoring
Reviewing Serious Adverse Events (SAEs), safety updates, and protocol deviations to ensure participant safety throughout the trial duration.
Continuous Surveillance
Conducting periodic progress reviews, site audits, and re-evaluations during trial amendments or extensions.
Objectives of the Ethics Committee
Protect Rights & Welfare
Safeguard the dignity, rights, safety, and well-being of all potential and enrolled human research participants.
Promote Ethical Standards
Maintain absolute independence, transparency, and scientific integrity during trial evaluations.
Equitable Research Oversight
Ensure vulnerable populations (e.g., children, elderly, economically backward, or cognitively impaired participants) receive appropriate protections in trial designs.
Timely & Vigorous Evaluation
Provide efficient, objective, and timely reviews of research proposals to support clinical innovation without compromising ethical benchmarks.
Who Can Approach the Ethics Committee?
Any entity or individual initiating, conducting, or overseeing clinical research or biomedical studies involving human subjects in or around the region can submit proposals for ethics review:
Principal Investigators (PIs) / Clinical Researchers (Doctors, academicians, and scientists conducting clinical trials).
Pharmaceutical & Biotechnology Companies (Sponsors proposing regulatory or post-marketing clinical trials).
Contract Research Organizations (CROs) managing multi-center or single-center clinical trials on behalf of sponsors.
Hospitals, Medical Colleges, & Healthcare Institutions lacking an in-house registered Ethics Committee.
Independent Medical Practitioners & Researchers conducting academic or investigator-initiated clinical research.
Feasibility & Site Selection
Identifying and preparing the right study site before the clinical trial begins. Assessing site capabilities, resources, and staff readiness. Ensuring each site is well-prepared for smooth and efficient trial execution.
Site Selection Support
We conduct market research, surveys and investigations covering disease, prescription and medical device data, and take interviews of physicians and medical staff.
Feasibility
Identifying potential sites and investigators, assisting with feasibility assessment & site initiation. Feasibility is vital to any trial, ensuring you're matched with the most feasible sites.
Contract & Budget Assistance
Efficient site contract management, cost analysis and budget negotiation for every trial that comes to us, cost analysis and budget negotiation for every trial that comes to us.
Site Activation & Training
Preparing study sites, staff, and essential documentation before trial initiation. Ensuring all requirements are completed accurately and efficiently. Supporting a smooth and timely start to each clinical study.
Study Staff Training
We appoint experienced CRCs and study managers at the site for smooth conduct of trials. GCP and study-specific training is provided to all study staff by our experts.
Site SOP Preparation
Site-specific Standard Operating Procedures are a must for any trial. We prepare site-specific, GCP-compliant SOPs for the smooth conduct of every study.
IRB / IEC Related
Assistance for faster submission and approval by the Institutional Review Board or Ethics Committee, ensuring complete documentation, compliance, and a smooth review process.
Study Conduct & Patient Care
Supporting patients and study staff throughout the clinical trial journey. Ensuring effective coordination, clear communication, and timely assistance at every stage. Helping maintain a smooth, compliant, and patient-focused trial experience.
Informed Consent Process
Every enrolled subject has the right to understand the trial. Our experienced study staff provide support throughout the informed consent process.
Patient Care
Patient safety is the primary concern. Our study staff ensure proper care is given to every subject, with subject comfort as the priority.
Subject Recruitment
Successful trials depend on effective subject recruitment. Our experienced CRCs & study team support efficient screening, eligibility assessment & timely recruitment.
Subject Retention
We make sure every randomized subject completes the study, through effective follow-up, proper ancillary care, and continuous support throughout the trial.
Safety & Compliance
Protecting subjects, investigational products, and essential documentation throughout the clinical trial. Ensuring compliance with regulatory requirements, protocols, and applicable GCP standards. Maintaining quality, safety, and integrity at every stage of the study.
Drug Dispensing & Accountability
Ensuring proper storage, handling, and dispensing of Investigational Products, with complete documentation of administration, returns, and destruction.
Adverse
Events
Ensuring effective detection, documentation, assessment, and timely reporting of adverse events, while maintaining accurate safety records throughout the study.
Site Master File Maintenance
Ensuring accurate completion, organization, and assembly of essential study documents, making site file maintenance easier and supporting compliance
IP
Management
Ensuring proper storage and handling of Investigational Products, with accurate temperature logs, shipment, retrieval, and destruction records.
Monitoring & Data
Keeping trial data and conduct on track throughout the study. Ensuring protocol compliance, accurate documentation, and timely issue resolution. Supporting smooth and efficient trial execution from start to finish.
Case Report Forms
Accurate CRF filling, handling & maintenance is assured. Our CRCs are trained & experienced on both paper & EDC-based data management platforms.
Monitoring & Auditing
We conduct internal monitoring at frequent intervals to ensure proper conduct of trials, keeping protocol deviations minimal or non-existent.
Close-out & Archival
Bringing every clinical trial to a clean and compliant finish. Ensuring all study activities, documentation, and site requirements are completed accurately. Supporting an organized and efficient close-out process.
Study Close Out
We ensure faster recruitment and proper completion of all subject files, confirm the site is ready for close-out before notifying the sponsor or CRO, and provide continuous assistance through to completion.
Archival
We provide third-party archival facilities with all required measures and provisions in place. Maintaining document integrity, confidentiality, and accessibility throughout the required retention period.