The Site-Specific Assessment (SSA) Officer responsibilities are distinct from those of the Human Research Ethics Committee (HREC) and the Research Governance Officer.
The granting of ethical approval by a HREC does not oblige an approving authority to grant authorisation at their site as the site may not have the capacity or capability to undertake the trial based on the protocol requirements.
As part of the process to confirm whether authorisation should be granted, the site-specific assessment officer confirms the clinical trial has undergone HREC review and received approval prior to commencement. Specifically, this position is responsible for undertaking authorisation activities in a timely manner.
The SSA process considers the following:
- Capacity for the site to support the project, including the availability of potential trial participants at the site
- Financial arrangements for the project
- Insurance arrangements
- Availability of appropriately certified and trained staff to meet the requirements of the trial
- Data access
- Local approvals relevant to the conduct of the trial
Preauthorisation activities including:
- Pre-authorisation must occur in a timely manner and may be undertaken in parallel with HREC review
- Liaising with the trial investigators and their teams and sponsors regarding the preparation of applications for site authorisation
- Managing the process of site authorisation, reviewing the SSA form and recommending authorisation of the trial to the Chief Executive Officer or delegate
- Ensuring a copy of the HREC approval, agreements applicable to the clinical trial, indemnity and insurance documents have been received and signed
- Ensuring collection of appropriate fees for site authorisation
- Documenting all site-specific clinical trial assessment decisions and maintaining a current record on the appropriate database
- Reviewing and managing amendment documentation related to authorised clinical trials
- Collecting and providing data on operational metrics to the governing body
Post-authorisation activities including:
- Managing and reviewing amendments to authorised clinical trial projects
- Having an oversight of authorised clinical trial projects through review of annual and final site progress reports submitted by the Principal Investigator
- Receiving complaints related to the conduct of a clinical trial and escalating these to the appropriate officer within the health service organisation
