Yes, I have seen all of clinical trials that are collecting data entries at my workplace (web-based software provider in clinical trials, it’s called Fusion eClinical Suite), they have been implemented these processes to ensure data quality and integrity.
Audit Trail/Time Stamp – this is mandated to implement and perform a functionality script of audit trail or time stamping to track changes to the data over time, it’s helpful to identify who made what changes or update in the system e.g. the “view audit log” button will be able to view and download the form of audit trail that displays the following details; section name, question, value, query ID, change/bypass note, date/time, user and role.
User Authentication and Access Control – this is functioned to implement user access that all end-users will be required to reset their own password by answering their security questions in every 3 months (old password can’t be reused) or in case they can’t remember this they will have to reach out assistance web-based software provider for verification as well as PI will have their confidential authorization code to sign subject records and their access in the system must be assigned to correct access (applicable role, site number and reports/modules) to perform data entries properly in the system for example Project Management Team will provide the update of the tracker and allow end-users to be assigned to newly released reports/modules and some module like Data Portal must be verified in the agreement contract before to proceed with assignment.
Edit Check and Logical Check – this edit check module has implemented to perform for all of clinical trials an this module can help validate data entered and ensure that it meets predefined criteria or standards in the system, the data makes sense within the context of the study. Within the edit check module will have sub-navigation tabs e.g. Edit Checks Manual, Edit Checks Auto, Open Edit Check Results, Closed Edit Check Results, all of these will help to track the completion of identifying inconsistencies or errors.
Data Backup and Recovery Plan – all members at my workplace have to be trained on SOP documents such as Business Continuity Plan POL, this provides a framework, guidance, and concept of operations to support businesses to continue and/or rapidly restore their critical business functions in the event of a disruption to normal operations. Key elements considered any of the following disruptions e.g. natural disaster, fire, war, civil unrest terrorism, pandemics, epidemics, IT or electrical grid failure and etc. My workplace is implemented in two core phases;
1. Preventative Planning: maintains electronic records of core business elements, as well as daily backups of electronic Mission Critical Systems at a secured location, which is equipped with 24/7 video surveillance systems, fire suppression systems, forced entry alarms, and door access control systems.
2. Response to Critical Function Failures/Business Premise Issues that must be implemented in the event of a failure. Depending on the risk level assessments for the disruptions triggered in any of the following categories (Communication System, Mission Critical Systems, Business Premises), a predetermined Business Continuity Activation plan will be initiated to mitigate the effects of the adverse events.
Additionally, there are concerned SOP documents have been provided to all members such as POL-2, Disaster Recovery Policy/ SDSOP-11, Production System Back-up/ SDSOP-11, Production System Back-up and SDSOP-11-T1: Database Test Restore Form.