LABORATORY FACILITY AT CCDC

The laboratory at CCDC is equipped to deal with all aspects of clinical biochemistry and basic genetics research. The lab has an integrated Chemistry immunochemistry analyzer from Abbott, Var II Turbo from Bio-Rad, a microplate reader from Bio-Rad, a Spectrophotometer from Thermo, and Gas chromatography from Agilent. For performing molecular biology experiments, the lab is equipped with a thermal cycler from ABI, NanoDrop from Thermo, Gel documentation system from Alpha Imager, agarose electrophoresis setup from Bio-Rad, and Refrigerated macrocentrifuges from Eppendorf. To support the research work, the lab has additional equipment like a Sonicator, Milli-Q water purification system from Millipore, tabletop centrifuges from Remi, water baths, incubator-shaker, electronic weighing balance, autoclave, UV crosslinker, single and multi-channel micropipettes etc. All the equipment is regularly maintained and calibrated.

The biochemistry section of the laboratory was established to study cardiometabolic risk markers in various studies; however, it is now expanding its horizons to other aspects of research, e.g., nutritional biochemistry. Since its inception, the biochemistry laboratory has performed more than 9,00,000 tests on approximately 75,000 samples. We have been analyzing biospecimens for clinical chemistry parameters, extended lipid profile, markers of cardiometabolic disorders, HbA1c, markers of chronic kidney disease, nutritional biomarkers and several other specialized assays, e.g. markers of inflammation, cytokines, adipokines, cotinine for our various research studies. The laboratory is a regular participant in an external quality control program by RIQAS (Randox International Quality Assurance Scheme) for Lipids, Clinical Chemistry, Glycosylated haemoglobin, urinary microalbumin, and UKNEQAS (UK National External Quality Assurance Scheme) for Insulin assays. It is also part of the EQUIP (Ensuring Quality for Urinary Iodine Procedures) program from CDC, Atlanta, for Iodine assay. Science graduates and postgraduates perform all the work with training in Medical Laboratory Technology and Biotechnology and more than ten years of experience. Standard Operating Protocols (SOPs) for various laboratory processes are diligently followed along with Good Laboratory Practices.

Institutional Ethics Committee of CCDC

We have a strong ethics committee where more than three-fourths of the members are external members of reputation and high standing in the scientific and academic world. We have a lawyer and layperson as required by Indian laws.

Functioning of the committee

We follow all the regulations and norms laid down by The Drug Controller General of India, Government of India (DCGI-GOI) and the Indian Council of Medical Research ICMR, Government of India. We also comply with the WHO Ethical guidelines, the Declaration of Helsinki and the Belmont Report. We are also registered with the United States Department of Health and Human Services, Office of the Human Research NIH ( USA), Office of Human Research Protection, which Expires on MAR/15/2026; Organization No: IORG0005264 (Expires on MAR/15/2026), OHRP FWA No: FWA00012746 which Expires on: MAY/12/2025.

We are in the process of registration with the Department of Health Research GOI. As per DCGI and ICMR, the Institutional Ethics Committee / Independent Ethics Committee expect to be promptly reported about

1. Any changes in protocol, patient Information sheet/ Informed consent form

2. Any severe event or development in the field

3. Any new information which has a bearing on the participants' safety, rights, and well-being.

Data Management

Data Management Capacity
Central to our operational excellence is a robust Data Management system meticulously designed to uphold the highest industry standards. Our repository is fortified by stringent Standard Operating Procedures (SOPs) are crafted with precision, guiding systematic data handling protocols. These SOPs act as guiding principles, ensuring not only consistency but also the utmost completeness in the collection and purification of data within our databases.

Database Development Expertise
Our database infrastructure is meticulously curated, with each application tailored in-house or outsourced to precisely align with project requisites. We embrace diverse platforms, ensuring customized solutions that strictly comply with 21 CFR Part 11 guidelines. Rigorous User Acceptance Testing (UAT-1 and UAT-2) further bolsters the integrity of our database structures post-development.

Monitoring and Reporting Excellence
Going beyond data handling, we specialize in providing comprehensive insights into data
collection progress and quality through adept report development and interactive
dashboards. These tools exemplify our commitment to transparency and informed decision–
making. Our team crafts reports and dashboards that offer real-time visibility into data
collection progress, enabling agile adjustments when necessary. Additionally, these
interactive interfaces serve as robust tools to monitor data quality, facilitating immediate
interventions to maintain the integrity and reliability of collected data. Our focus on these
monitoring mechanisms ensures adaptive data management, promoting efficiency and
accuracy aligned with evolving project needs.

REDCap (Research Electronic Data Capture) Proficiency
Our in-house proficiency with the REDCap platform showcases our prowess in database
development. This sophisticated, web-based software is a cornerstone for data capture in
research studies. REDCap offers intuitive interfaces for validated data capture, robust audit
trails, automated data downloads into popular statistical packages, and seamless integration
with external sources. Over 15 completed projects across varied database platforms and 18
ongoing projects thriving on the REDCap database testify to our commitment to maintaining
the sanctity and security of sensitive information.

Data Management Plan
At the core of our strategy lies meticulous planning tailored to each project's unique
demands. Transparency and consistency define our approach, with detailed data-cleaning
methodologies ensuring stringent protocols and accountability throughout the data
lifecycle.

Core Lab at Sri Ramachandra Medical College and Research Institute, Chennai

The Core Imaging Lab at Sri Ramachandra Medical College (SRMC) serves as the central imaging analysis hub for the Precision CARRS project, supporting both the Chennai and Delhi sites. This state-of-the-art facility is instrumental in ensuring consistent, high-quality imaging data collection and analysis across the study.

The lab is responsible for the organization, processing, and interpretation of various imaging modalities, including:

• Echocardiography with advanced assessments of cardiac function and structure
• Carotid Intima-Media Thickness (IMT) measurements for vascular health evaluation
• CT Coronary Calcium Scoring for non-invasive assessment of coronary artery disease risk

All imaging data undergoes detailed analysis using specialized software and is securely stored on the Network Attached Analysis System (NAAS). For each enrolled participant, a comprehensive digital folder is created containing all relevant imaging reports and datasets, Echo, Carotid, and CT, which is uploaded to NAAS following a rigorous quality assurance review.

The Core Lab ensures standardized imaging protocols and high analytical precision, playing a crucial role in advancing the goals of the Precision CARRS project.