Multiple Trials
Multiple clinical trials are managed simultaneously. The solution maintains the complete history of each trial for an indefinite period.

Biographical details are secured for access by authorized personnel for emergency contact, the initial collection of identity data and contact details during enrollment are hidden.

At all points of contact the Participant is identified by manually inserting the unique participant code or the use of biometric scanning. Biometric scanning is also used as a means of electronic signature at necessary points in the trial process.

As per GCP guidelines and regulations, advanced document management facilities control images/photographs of:

Test Results

Participant and Clinical Staff supporting documentation

Clinical Trial Sponsor documentation

Contracts

IP information documents

SAE reports

These images can be scanned or imported into the system. Documents are consolidated with trial data.

The DigiData Workflow Management Solution allows for prescribed data captured by clinical staff to be routed to assigned management staff such as the Principal Investigator for review and approval/acceptance/action.

The workflow will also initiate follow-up tasks to the locator team for missed visits.

Administration staff are notified when a participant visit is completed for and that the stipend can now be paid and recorded.

This workflow routing can be accompanied by an SMS message or an email to the receiving party to alert them that a response action is required.

A comprehensive logging and messaging capability to send messages to participants including notification and reminders of scheduled visits and/or missed appointments.

Notifications are also generated in instances where an adverse test result indicates that the participant seek external medical intervention or return to the facility for intervention.

Messaging can be extended to include active monitoring of participant compliance through an interactive USSD platform which requires confirmation by a participant that the IP has been taken.

The system provides a similar comprehensive logging and messaging capability that communicates to trial staff and management. These messages typically notify requests for intervention as part of the process or request a review of participant examinations or test results. They would also include requests for review and authorisation.

In the process of tracking the progression of a Trial, the history of a Participant or the deployment of a Staff Member, the Dashboard provides a unique caopability. At the point that the system displays the required data at the detail level that is required, the simple selection of a ‘Download’ option on the Dashboard screen extracts the data from the Dashboard and inserts it automatically into an Excel spreadsheet. This can then be used to support unique reporting and analysis.

During the configuration of a Clinical Trial, The Group definition supports the definition of the Stratification criteria as well as specific selection criteria as required uniquely for each Clinical Trial. Once defined, the system will randomly automatically allocate Participants to each group. The system conforms to double blinding principles and the Group allocation of the Participant is maintained confidentially in the system and only used for Trial progression reporting. Selected management will have access to the participant group information.

DigiDataCT provides a Query Analyser that supplements the Dashboard. The Query Analyser allows unique and targeted queries to be built based on any criteria and data in the system. The query will execute and return the selected results required. The query can be stored for re-use.