For sponsors
Quality and standard operating procedures
The standard operating procedures, training arrangements and quality management processes under which studies at this site are conducted.
- Standard
- ICH E6(R3)
- SOP review
- 2-yearly
- GCP currency
- 2-yearly
01 / Framework
SOP framework
All procedures are maintained as controlled documents with version history and a documented rationale for each revision.
- Governance
- Quality manual, SOP on SOPs, document control and versioning, periodic review on a two-year cycle with out-of-cycle revision when a process changes.
- Trial conduct
- Feasibility and site selection, protocol training, delegation of duties, informed consent, screening and eligibility, randomisation, dosing, protocol deviation identification and reporting.
- Investigational product
- Receipt, storage, temperature excursion management, dispensing, accountability, return and destruction, emergency unblinding.
- Safety
- AE and SAE identification, assessment of causality and expectedness, reporting timelines to sponsor and HREC, SUSAR handling, pregnancy reporting, medical emergency response.
- Data
- Source data definition and location, source documentation standards, ALCOA+ principles, data entry and query resolution, correction of records, archiving and retention.
- Samples and equipment
- Collection, processing, labelling, storage, shipment, chain of custody; equipment calibration, maintenance and temperature monitoring with alarm escalation.
- Quality management
- Deviation logging, root cause analysis, corrective and preventive action, effectiveness checks, internal audit programme, management review.
- Privacy and records
- Participant confidentiality, handling of health information under Australian Privacy Principles, essential document filing plan and trial master file maintenance.
02 / People
Training and delegation
Training records and delegation of duties are maintained for all staff performing trial-related activities.
Training matrix
Every role mapped to the SOPs and protocol-specific training it requires, with completion dated and held in the trial master file. No delegated task without recorded training against it.
GCP currency
ICH E6(R3) GCP training refreshed every two years for all staff performing trial-related duties, plus role-specific training in consent, safety reporting and IP handling.
Delegation log
Maintained and signed by the Principal Investigator, updated before any task is performed, with start and end dates for every delegate.
03 / In practice
Quality management during a study
Deviation reporting
All protocol deviations are logged with a root cause assessment and a corrective and preventive action where warranted, and reported to the sponsor and, where required, to the HREC.
Essential document management
Essential documents are filed as generated against a documented filing plan, with periodic completeness checks, so that the trial master file remains inspection-ready throughout the study.
Source data definition
A source data location list is agreed with the sponsor at site initiation and maintained for the duration of the study.
Internal audit
Self-inspection against the quality system is conducted on a 12-monthly cycle, independently of the study team, with findings tracked to closure.