rDNA / Biosafety
This module allows both the management of the facilities in which recombinant DNA research is carried out and approval of the work being done within them. The system has two elements: the facility subsystem and the protocol subsystem and the two relate through the facility code.
The Facility subsystem includes the capacity to combine or split out rooms within a facility and allows for the workflow management of the inspection and approval processes by the Australian Office of Gene Technology Research (OGTR) inspectors. The workflow in this system alerts the facility owner/manager of the process and any modifications required to the facility.
The protocol sub-system ensures that work is done within an appropriately certified facility and, as with Human and Animal Ethics modules, it facilitates the committee process and that of notifying researchers of the results of the committee's approval.
Key data elements stored in the system are:
- All investigators both internal and external and both staff and students
- Affiliation data based on the internal structure of the institution, or the affiliation of external collaborators
- User configured questions for annual review of protocols
- Workflow management of variations to a protocol
- Workflow management of variations to a Facility
- Periodic monitoring of progress with the protocol
- Changes required for the approval of a protocol together with researcher's responses to these requirements
- Committee decisions and minutes relating to a protocol
- Comprehensive data relating both to the current status of a facility and also on its history
- Workflow surrounding meetings of committees assessing protocols
