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
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.,
The registered Ethics committees can adequately manage all SAE information that includes:
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.
System integrated SAE management into Ethics committee procedures offers following ease in functioning:
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: