Research Facility : Data Management Centre
The Data Management Centre (DMC) at THSTI provides state-of-the-art data management support to in-house intramural and extramural funded, clinical research projects.
A core team comprises a data scientist, a programmer, a data manager and two data entry operators. The DMC has competence and experience to support studies including large cohorts and multicenter clinical trials, through the entire cycle of the study, beginning from data capture plan to consistent and time-bound delivery of accurate, analysis-ready data.
The DMC has the proficiency and provides both paper-based and eCRF data capture support. The clinical data management systems (CDMS) developed in-house for both type of data capture are robust, validated and ensure reliable data quality with an audit trail. The CDMS at THSTI is installed in a secure and validated IT environment and the DMC provides customized data management services on the platform, which include development of data management plan; case report form (CRF) designing; preparing study-related technical documents like annotated CRF, data validation plan; database development through the development of electronic data capture systems; developing standard operating procedures for quality adherence and customized CRF filling guidelines; SAE (serious adverse event) data reconciliation; data import set-up for third party (central laboratory, images, etc.); customized reports; procedures for data sharing, database lock prior to analysis and data archiving.
The data management centre has developed an in-house laboratory management system (LMS) using barcodes. This helps track the journey of a biospecimen from collection till the time it is analysed or stored in the biorepository.
Data security and storage:
It is important that all data be held securely, be robustly backed up and its confidentiality safeguarded. Data integrity and confidentiality of data at the DMC is maintained within the CDMS and LMS by a robust program security which gives restricted access to users, requires a login and password to access the program, monitors user activity, has a time-stamped audit-trail system to track changes to data. Data generated or collected is de-identified using unique identification codes and then entered in the database. In addition to this, there is controlled access within the DMC and the data archival space.
All the data entered in the database is transferred to the server at THSTI. At least one mirror backup of the data is kept in the server at THSTI, protected by a password and accessible to only authorized users. Additional processes for data back-up like use of external hard disks for time bound back up every 15 days are in place. The external hard drive is kept at a location away from the DMC at THSTI.
Data access and ownership:
The following principles apply:
1. Ownership of data is decided by the PI and other stakeholders generating the data;
2. Access of data to all stakeholders for the conduct of the project.