SafetyLink

The OmniComm SafetyLink module allows relevant data collected in TrialMaster EDC to be transferred to, and then managed by SafetyLink.  This data is typically comprised of the following:

• Patient Demographics
• Medical History
• Death
• Adverse Event [Multiple AEs selectable]
• Procedures [Lab and Diagnostic Procedures]
• Study Drugs
• Concomitant Medications
• Event Description [from site]
• Investigator information

SafetyLink will log details of the submission and any changes to data automatically.  Users can then create the report in E2B format which may be imported into other Safety systems which are E2B compliant.  Users may re-enter SafetyLink to work on incomplete SAE cases from an SAE Review Task in TrialMaster.

Following the initial submission of a report, the system will create a new version each time data updates occur in TrialMaster and a follow-up report is required.  Data changes are transferred from TrialMaster iCRFs to the SAE report in SafetyLink.  Tasks and E-mail notifications are automatically generated by SafetyLink to streamline the process of managing SAEs and ensure regulatory compliance for expedited reports.

From an AE iCRF in TrialMaster the user can enter information regarding the Adverse Event and indicate if the event is Serious.  If the event is indicated as serious a pop-up is presented requesting the user to create a new SAE in SafetyLink, or Associate with an existing SAE.

Required data is automatically populated into SafetyLink as Read only and can be reviewed using the appropriate tabs.   Where multiple records can exist, for example Medical History, Concomitant Medications etc, the user can select the appropriate records to transfer to SafetyLink for reporting.

Using a single click the user can generate the E2B file.  The file is posted to a Secure FTP site (SFTP) for subsequent processing e.g. importing to other E2B compliant systems.  Safety data is exported using the E2B standards.  This allows safety data to be exported to other E2B compliant applications.  For example SafetyLink will allow safety data to be imported into OmniComm’s eClinical Adverse Event Reporting System (EAER) which can then generate Regulatory Reports and Electronic Submissions.  An automatic e-mail notification is sent to indicate that an E2B file has been generated.

Key Features	Key Benefits
Automatic Report ID generation and Versioning.	Following the initial submission of a report, the system will create a new version each time data changes occur in TrialMaster and a follow-up report is required
Automatic transfer and update of relevant information.	The following data is transferred or updated: Patient Demographics Medical History Death Adverse Event [Multiple AEs selectable] Procedures [Lab and Diagnostic Procedures] Study Drugs Concomitant Medications Event Description [from site] Investigator information
Automatically create tasks/notification email	Streamlines the processing of AEs to ensure Regulatory compliance for Expedited reporting.
Generate E2B compliant file	Allows information to be exchanged with other E2B compliant systems for analysis and reporting of AEs.