Suspected unexpected serious adverse reactions (SUSARs) are reports of incidents which happen during a clinical study and must be distributed to national competent authorities and a number of other recipient groups such as Ethic Committees or Institutional Review Boards, but also to all investigators participating in the respective studies. Many companies have implemented business rules beyond the regulations to further automate the SUSAR distribution internally and to business partners.

The various recipients must be informed using specific formats and the content must also be blinded or unblinded according to given regulations. Beyond these basic requirements, it is very helpful if the system supporting the SUSAR distribution process allows the following:

  • Always use current recipient lists from master systems, e.g. a CTMS, without additional administrative overhead
  • Cross-reporting
  • Minimize the number of SUSAR distributions to individuals by combining multiple elements into a single distribution
  • Correct retrospective reporting considering the latest IB content, e.g. when a new investigator joins an ongoing study program
  • Capture all activities in an audit trail
  • Minimal administrative effort in setup and maintenance of SUSAR distributions
  • Low learning curve and high acceptance rate for recipients, ideally superseding formal system training
  • Automatic generation of cover letters
  • Collect and track acknowledgements
  • Defined escalation schemes with alternative distribution routes
  • Full monitoring and alerts
  • Support manual interventions, such as a manual resend
  • Robust reporting capabilities

“It is very helpful if the system supporting the SUSAR distribution process minimizes the number of SUSAR distributions to individuals by combining multiple elements into a single distribution.”

psiXchange – Compliance Through Automation

The review of the “ICH Topic E6 (R2) Guideline for Good Clinical Practice” and the “Clinical Trial Regulation” (536/2014) in the EU expand on the duties of a study sponsor and to a certain extent also investigators with the basic intent to improve sponsor oversight and quality control. These two closely relate to monitoring and data management which are the topics with the highest number of critical and major findings in the EU in the period from 2000 to 2012 as reported by the EMA.

psiXchange is a reliable, fully automated system allowing for efficient management of reporting obligations, and is used by several of the top twenty contract research organisations and pharmaceutical companies.

Customers are especially delighted by the fact that unlike with rule-based systems and portals the effort for setup and maintenance for SUSAR distributions is reduced by usually at least an order of magnitude. psiXchange can work with any document from any third-party system or any database through a growing set of in- and out-connectors which can be easily adapted to any need for integration with existing data sources. Existing systems as well as existing data are not modified. Integration happens at the data-level.

Data acquired from different source systems can be cross-validated before use in the automated SUSAR distribution process.

psiXchange is equally flexible with the number of parameters, or data relations, it considers in the SUSAR distribution process. This allows to adjust the system to (almost) any process need. One application of a more fine-grained approach is, for example, the request by more and more ethic committees to avoid over-reporting.

Several standard methods of distribution are available:

  • Fax to one or multiple recipients
  • Email attachment with a cover letter
  • Email with download link for self-provisioning
  • The link is fully configurable as to duration of availability or number of downloads.
  • See our information of security implementation with psiXchange in SUSAR distributions and other uses.

Further distribution methods can be configured with the flexible output connectors.

Customers who have implemented psiXchange for automated SUSAR distribution report up to 80% reduction in costs, and up to 90% reduction in resource requirements while experiencing compliance rates above 97%.

“Customers who have implemented psiXchange for automated SUSAR distribution report up to 80% reduction in costs, and up to 90% reduction in resource requirements while experiencing compliance rates above 97%.”