IEC’s Safety Data Tracker

Current regulatory guidance documents clearly define roles and responsibilities of Independent Ethics Committees/Institutional Review Boards (IECs/IRBs). These IECs/IRBs have remarkable role analogous to that of Regulatory authorities for review and assessment of trial related documents and procedures, the universal aim being to safeguard and protect public health, privacy and confidentiality.

However, it is equally important to have organized, self-sufficient and accessible documentation for all committee activities that are trial related (includes pre-, during and post – trial activities).
Serious adverse event (SAE) reporting and analysis is also a lengthy task for IRB/IECs due to

  • Stringent submission deadlines to national authorities
  • Volume of accurate information to be collated
  • Thorough documentation of the event specific details
  • May necessitate urgent involvement of a subject expert

All these processes are required to come to a unanimous decision for subject/trial and timely compensation depending on case.
As a matter of Good clinical practices, the relevant records and document practices should be in place for all Human Ethics Committees, irrespective of their nature of work review, i.e.,

    • Academia or Research oriented
    • Institutional or Independent
    • Scientific or Ethical

    The registered Ethics committees can adequately manage all SAE information that includes:

    • Patient data
    • Suspect product/Concomitant medication(s) information
    • Investigator & Sponsor details
    • Ethics Committees administrative meeting details for individual case/trial phases

    As per the Indian regulations on SAE pre-screening prior to submission, it is mandatory to submit specific checklist of SAE details to review the case on priority and give recommendations. We offer a pragmatic solution for effective IRB/IEC administration and adverse event management to duly fulfill their role in patient safety.

    The SAE management tool has been designed keeping in focus all the regulatory SAE fields required.

  •  IEC’s Safety Data Tracker

System integrated SAE management into Ethics committee procedures offers following ease in functioning:

  • Traceable record during any phase of a clinical trial
  • Concise summary of clinical trial phase/study design
  • Insight into number and nature of SAE(s) during trial duration and for a particular suspect product
  • Significant meeting records of SAE review by members can be uploaded and archived such as:
    • Committee meeting minutes
    • Source documents at Investigator site(s)
    • Voting details/Declaration of conflict of interest of individual members
    • Member credentials
  • Inbuilt Appendix XI (Schedule Y: Data Elements for reporting SAEs occurring in a clinical trial)
  • Causality assessment of all stakeholders accessible on one platform
  • Controlled access with audit trail
  • Complete report view critical to Committee decision-making

Additionally, the meeting archives are traceable, an option non-manageable as the pile of physical records amplify with increased frequency of committee meetings.
Key administrative features for process efficiency:

  • Legible and accountable records stand by itself in vendor audits and regulatory inspections
  • System generated mail and/or message (SMS) alerts on data entry of SAE
  • Precise tracking of report submission timeline to applicable regulatory authority
  • Document archives at the desk of any/all IRB/IEC members many years post-trial close out
  • No process inconsistencies due to sudden absence or change of coordinating member/member secretary