Yes, I have experience managing data in a software program called DFexplore. The data will be stored and managed in the clinical data management system. DFexplore is a standalone application. It does not need to run on any specific web browser. Since my company provides data management services, we must complete all these steps before providing it to our clients. So, we implemented several data management processes within DFexplore to ensure data quality and integrity:
Audit trail/Time stamp: All collected data and actions (data entry, modification, and deletion) in the system can be tracked using an audit trail that includes date, time, and username will be shown in the audit trail report.
User authentication and access control level: Access is only granted to qualified personnel as requested by the sponsor and/or investigator of the study. The user will have access to only study and application features that the study administrators have granted permission to use. The level of access control will be defined per each user’s roles and responsibilities (e.g., data entry, study coordinator, principal investigator, or monitor). Each person responsible for entering or reviewing the study data in the eCRF will receive a unique username and a temporary password from study administrators (DM team).
Edit check and logical check: The DM team will implement the edit check (EC) program into the study database to check missing data/consistency of the database during/after data entry based on “Edit Check Specifications (ECS)”, while the user is entering the study data into the eCRF on the server, the edit check program will make certain checks and may flag that the data needs to be reviewed, confirmed, or revised. This process of automated edit checks will be implemented to reduce errors in the data entry process.
Data backup and recovery plan: We will maintain the database by allocating sufficient system storage for the study database and upgrading database software and associated applications, if necessary. Providing routine backup of the database storage and performing routine virus checks on incoming and outgoing data. The backups will be performed on a daily basis for their ability to adequately restore the backed-up data on the backup server.