This module fully meets the requirements of the Australian NHMRC National Statement regarding the assessment and approval of research affecting humans. Compliance with this strict standard means the module is sufficiently robust to meet the needs of all countries.
The module features a sophisticated questionnaire builder which allows an institution to design their own questionnaires with embedded logic and decision trees. Questionnaires can be designed to ensure researchers are presented only with questions relevant to their application, minimising data entry. An application's level of risk can be determined automatically based on answers to questions and then directed within IRMA to ensure each application receives the appropriate level of review. The flexible design allows institutions to amend questionnaires very quickly and make these amendments available to their researchers immediately.
Institutions can design an unlimited number of online forms which capture all information required for an application, variation or report. When required the form can include a questionnaire and the ability to upload files. For each section of a form it is also possible to define help prompts and to provide links to websites. The level of approval required for each type of form can be defined and once a form is submitted online approvals are automatically sought. As with the questionnaires, the forms can be amended very quickly.
Online forms enable pre and post submission review of an application by administrators in addition to being reviewed at one or more meetings. The meetings functionality fully supports the processes associated with holding an ethics meeting including producing agendas and minutes. The IRMA screens used during a meeting are optimised for projectors and tablets meaning there is no need for printed material during a meeting.
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 your institution, or the affiliation of external collaborators
- Questions defined by the institution
- Workflow management of variations to a protocol
- Workflow to track the progress of reporting, including due dates for periodic reporting
- Workflow management of conditions on a protocol
- Committee decisions and minutes relating to a protocol
- Comprehensive workflow surrounding meetings of committees assessing protocols
- Snapshot of different versions of a protocol providing a full audit trail of changes to a record
- Relationships to records in other modules such as a related grant or publication
- Events, including adverse events
- Risk level and current status of a protocol