Clinical Trials

Overview

A Clinical Trial Centre (CTC) is an essential facility in medical research where clinical trials are conducted to evaluate new medical treatments, drugs, devices, or interventions. The primary goal of a CTC is to ensure that these trials are conducted safely, ethically, and efficiently. Clinical Trial Centre constituted under The University designates a CRC for each study. The CRCs involved in a particular study report directly to the Head, Clinical Trials, Adichunchanagiri Hospital, Adichunchanagiri University.

Mission

To promote an atmosphere of collaboration with the clinical research sectors

To promote clinical research among healthcare professionals

Vision

To become one of the world's most inventive centres for clinical research.

To provide patients with superior medical treatment.

The objectives of Clinical Trial Centre

Attraction of the new studies to sites with centralized administration.
Coordinate study administration (submission to Ethic Committee, budgets, regulatory submissions, documents batch preparation, document preparation and etc.,)
Managing Sponsor payments in consultation with the institution
Support in project specific training
Staffing, hire, train and compensate site employees (coordinator, sub-investigator, study nurses etc.,)
Maintaining Adequate Resources and Communication with IEC.
Medical Care of Study Subjects with Compliance with Protocol
Investigational Product
Solve Study Related issues
Progress Reports Generation
Safety Reporting
Premature Termination or Suspension of a Study
Final Report Preparation
Quality control and quality assurance activities on research site level

Key Components of a Clinical Trial Centre

Infrastructure:

Dedicated spaces for patient visits, including examination rooms, treatment areas, and spaces for clinical procedures. Other facilities include:

A well-equipped dedicated Trial centre with 24-hour CCTV surveillance.
Multiple Ethics committee for timely clearance.
Biometric access enabled for Drug storage area with Deep Freezer facilities and appropriate temperature monitoring with the help of Thermo hygrometer.
Biometric access enabled Archival Room for proper storage and maintenance of trial-related documents with 24-hour CCTV surveillance as per the regulatory standards.
Independent work station for the conduct of trial activities.
Independent network with high-speed internet.
Single Window finance operation for ease of access
Centralised Fire Extinguisher.
Rolling Stack

- Board Room, Confidential Consenting Room, Treatment Room & Examination Room.
- Easy access to Central Lab, OPD, OT & Emergency.

- Equipped for sample processing and storage, often including specialized equipment for various types of assays.
- Secure electronic systems for managing trial data, including electronic health records (EHR) and clinical trial management systems (CTMS).

Staff:

Principal Investigators (PIs)
Clinical Research Coordinators (CRCs)
Nurses and Medical Assistants
Regulatory Specialists
Data Analysts and Biostatisticians

Regulatory and Ethical Oversight:

Reviews and approves trial protocols to ensure ethical standards are met.
Adherence to guidelines set by agencies such as the FDA (Food and Drug Administration) or EMA (European Medicines Agency).

Functions of a Clinical Trial Centre:

Designing trial protocols, including selection of appropriate study populations and endpoints.
Preparing detailed plans for recruitment, intervention, follow-up, and data collection.
Identifying and enrolling eligible participants, often involving extensive outreach and screening processes.
Informed consent process to ensure participants understand the trial and its potential risks and benefits. Administering treatments or interventions as per the trial protocol.
Monitoring participants for adverse events and overall health throughout the study.
Collecting and managing data rigorously to ensure accuracy and reliability.
Ensuring data integrity through proper collection, entry, and storage practices.
Conducting interim and final analyses to assess the efficacy and safety of the intervention.
Preparing reports for regulatory bodies and stakeholders.
Publishing findings in scientific journals and presenting at conferences.
Communicating results to participants and the broader public.
Regular audits and monitoring to ensure compliance with protocols and regulations.
Continuous training and development for staff to stay updated on best practices and new regulations.