IRB/IEC Solutions
Siara is committed to educating and developing the skills of Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs).
IRBs/IECs reviewing protocols involving interventional studies or clinical trials in humans must comply with the requirements outlined in ICH GCP Section 3 (Institutional Review Board/Independent Ethics Committee (IRB/IEC)).
Siara has developed a curriculum specific for IEC comprising of two customised workshops:
The Roles and Responsibilities of IRB/IEC
IRB/IEC: Ensuring Compliance at Investigative Sites
IRB/IEC: Ensuring Compliance at Investigative Sites
This 2 day workshop will provide an in depth understanding of the expectations from an IEC in term of processes and procedures. Guidance will be provided on the SOPs that need to be established to ensure the IEC is in compliance with ICH GCP. Details of the SOPs will be addressed as well as the procedures and documentation expectations from an IEC.
IRB/IEC: Ensuring Compliance at Investigative Sites
IRB/IEC: Ensuring Compliance at Investigative Sites
IRB/IEC: Ensuring Compliance at Investigative Sites
This 2-Day workshop is targeted specifically towards IEC members and will guide them in detail on how to conduct a compliance review at Investigative sites. The workshop is directed towards the requirements of Good Clinical Practice and the methods for assuring that these requirements have been met. The workshop will concentrate on the
This 2-Day workshop is targeted specifically towards IEC members and will guide them in detail on how to conduct a compliance review at Investigative sites. The workshop is directed towards the requirements of Good Clinical Practice and the methods for assuring that these requirements have been met. The workshop will concentrate on the practicalities of conducting a clinical trial compliance review. Tools and templates will be provided to ensure a comprehensive compliance review is conducted