CLINICAL DATA MANAGEMENT
Introduction
In today’s scientific and medical world, various issues in clinical trials and research have permeated every society and every field in medicine. Ethics and in particular the quality of research are two aspects of clinical research. The advances in technology have greatly helped high quality clinical data management. It is therefore of utmost importance to achieve optimum quality in the conduct, analysis and report of a clinical trial. The need to provide quality data management and training of personnel, has spurned on the creation of an Advanced Clinical Data Management Centre at the Department of Biostatistics, Christian Medical College (CMC), Vellore, India. This facility has great potential to impart world class trainings and data management services for clinical trials.
GOALS
- To provide quality service in the conduct of clinical trials data management in compliance with Clinical Data Interchange Standards Consortium (CDISC) standards, International meeting on Harmonization-Good Clinical Practice (ICH-GCP) and Food and Drug Administration (FDA) regulatory requirements and guidelines.
- To conduct training courses in critical aspects of clinical data management such as Electronic Data Capture and Audit Trail software, Serious Adverse Event and Drug Coding using software, Principles of Quality Assurance and Quality Control, and Standard Operating Procedures (SOP) writing for clinical research.
- To provide Bio-statistical services for data analyses and scientific report writing
Clinical Data Management Services
- Data Management Plan
- CRF/eCRF design and development
- Database Design, Screen Testing & Development
- Edit, Validation & Design check programming - User Acceptance Test
- Data Entry
- Independent data Verification – Data Entry Quality Control
- Data Validation and Cleaning
- Query Management
- Medical Coding
- Serious Adverse Event (SAE) Reconciliation
- Database Lock and Audit
- Delivery of Clean Data Files, Database Release & Documentation of Clinical Data Management Report
- Data Archival and Storage
- Handheld Devices Data Collection design & development tool
Biostatistics Services
- Study design (Simple, Sequential, Adaptive Designs, and Observational study design)
- Analysis and reporting of pre-clinical and Phase I-IV clinical trials of
- various designs to match the objectives of the study
- Randomization – envelops, fax or web
- Unscheduled interim analyses
- Post-hoc and exploratory analyses
- Formal interim and final analyses
- Statistical consulting
- Meta Analyses (Frequentist, Bayesian and Empirical Bayes)
- Bayesian analyses
- Bioinformatics (Data analyses and Reporting)
- Geographical Information System Mapping and Analyses
- Modelling and Much more...
- Big Data analyses (Prediction / Classification and Imaging)
Registry Web link: https://cmc-biostatistics.ac.in/HCC