GCP Inspection Program was introduced by TGA in 2022 with objective to straighten the TGA’s monitoring activities and protect the safety and well-being of the clinical trial participants participating in phase 1 to 3 clinical trials. The program not only ensures compliance with regulatory and ethical requirements (Therapeutic Goods Act 1989, Therapeutic Goods Regulation 1990, Therapeutic Goods (Medical Device) Regulation 2002, GCP Guidelines ICH E6 R3 (ICH E6 R3 GCP Principles and Annex I with TGA annotations expected to be adopted in January 2026), ISO 14155:2020 (soon to be replaced by ISO/FDIS 14155), National Statement on Ethical Conduct in Human Research (The National Statement), but also aims to educate sites so they can improve systems, documentation, and trial conduct.
The scope of the inspection by TGA at present include:
- Investigators sites conducting trials under CTN and CTA schemes (public and private sites).
- Investigator- Initiated trials.
- Parties contracted by the sponsor to conduct specific trial activity.
- Trials involving medicines, biologics and medical devices as Investigational Product (IP).
TGA does not currently inspect:
- Sponsors of clinical trials.
- Human Research Ethics Committees (HRECs).
- Approving Authority (AA).
- Research Governance Office (RGO).
- Studies conducted under the Special Access Scheme (SAS) or the Authorised Prescriber (AP) scheme.
TGA focuses its inspection on five areas, and these include:
- Protection of participants.
- Protocol compliance.
- Documentation.
- Therapeutic Goods/Investigational Product (IP).
- Trial management.
During the inspection, the inspectors will review and evaluate the following, but not limited to:
- Ethics approvals and reporting to HREC.
- Completeness of clinical trial documents (e.g. IB, PICF, protocol, amendments).
- Informed Consent process and records.
- Qualifications of the investigator(s).
- Delegation of duties.
- Handling protocol deviations.
- Data entry and source data verification.
- Monitoring program and executed monitoring visits.
- Radiations used (if applicable).
- SAE/AE recording and reporting.
- Investigational Product (IP) storage, accountability and blinding.
- Overall trial management and oversight.
The highest number of deficiencies reported by TGA up to date were identified in the areas of Protection of Participants and Documentation, closely followed by Therapeutic Goods/Investigational Product (IP) area. Whereas the area with the highest number of critical and major deficiencies included Protocol Compliance, IP and Trial Management, as reported in the GCP Inspection Program Metrics Report 2023-2024.
In general, these included, but not limited to:
- Failure to meet sponsors responsibility.
- Inadequate accountability of the IP and/or control of IP (e.g. missing records, lack of storage access control).
- Failure to follow the approved protocol.
- Poor monitoring and oversight of trial conduct.
- Inadequate subjects’ protection, informed consent issues (e.g. missing signatures, improper process, inadequate qualification of the staff conducting the consenting).
- Failure to follow the follow the approved protocol, protocol deviations.
- Inadequate and/or inaccurate case history records.
- Inadequate safety reporting (e.g. failure to collect, document and report information required for safety and efficacy assessment).
- Investigators conflict of interest not disclosed.
- Missing IB and PICF in the HREC submissions.
- Failure to provide appropriate medical care.
- Medical decisions made by non-medically qualified staff.
- Failure to maintain and/or retain adequate records in accordance with GCP requirements.
- Inadequate study records retention.
- Lack of adequate training of personnel involved in the clinical trial.
- Quality SOPs procedures not up to date.
- Inadequate randomisation and blinding procedures.
TIPS TO PREPARE FOR GCP INSPECTION:
Below is described on how to prepare for inspection. This is not meant to be an exhaustive list of preparation requirements, though:
Quality System:
- Training and Qualification – ensure training is up to date for the Investigators and all personnel involved in any of the studies at the site including GCP training, CVs of all personnel are updated, signed/dated.
- Study Documentation – ensure all study approvals are in place and available/filled, study plans approved and current, documentation signed as appropriate and dated, TMF/ISF are complete, deviations and CAPAs have been followed up and effectiveness assessed as per internal approved procedure(s).
- QMS SOPs – SOPs versions are current, and SOPs have been implemented, and records are available to confirm compliance with the approved SOPs. Any changes in the Delegation Log have been approved by the Investigator.
- Suppliers – ensure program for supplier evaluation and approval is in place and updated as per procedure. Contracts are current and signed.
Facility and Equipment:
- Facility is clean, and documents filed appropriately.
- Security and access requirements in place.
- Program for pest control, fire control and waste management in place.
- Equipment has been calibrated, and calibration stickers are current.
- Maintenance schedule in place and followed.
- Storage conditions are temperature controlled, and the monitoring temperature devices are calibrated.
Computerised systems
- All computerised systems used for activity in the study (including but not limited to signing documents, Trial Master File management and document storage/archiving, portable collection of data from the participants, IP management, data management activities, software for analysing and reporting of data etc, are validated. The extent of the validation should be based on risk to safety of participants and validity of the study data.
- Procedure is in place for audit trail, data back up and disaster recovery and periodically tested to ensure its efficiency.
Study Specific:
Informed Consent Process:
- Consenting procedure is in place and approved.
- The last version of the PICF approved by the HREC is used.
- Personnel conducting the consenting are trained and have the appropriate qualifications.
- Document participant understanding study requirements, had chance to ask questions and have voluntarily agreed to participate in the study.
- Ensure consent is obtained before any study activity is initiated.
Protocol:
- Track and record deviation from the protocol.
- Verify inclusion/exclusion criteria as per the approved protocol.
- Record and report SAE/AE. Any medical decisions must be made by medical personnel and records are available.
Investigational Product (IP):
- Record accounts of IPs (e.g. received, prepared, administered, returned, destroyed etc.)
- Ensure secure and temperature-controlled storage.
- Ensure appropriate blinding and randomisation process.
How to avoid the deficiencies in the next GCP inspection?
The approach that the clinical sites and sponsors can take to avoid the deficiencies include:
Education and Training
- Role specific training program (e.g. informed consenting process to be conducted only by qualified staff and trained to conduct consenting process).
- Document all completed training activities.
Adequate Staffing
- Monitor staffing and resource requirements.
- Allocate sufficient staff for protocol activities.
Senior Management Oversight
- Engage leadership in protocol changes, resourcing, and CAPA management.
- Promote a culture of compliance and quality.
Internal Audits and Mock Inspections
- Identify issues before regulators do.
- Test readiness and reinforce staff confidence.
Sites that invest in robust QMS, thorough documentation, well-trained staff, and strong oversight not only reduce inspection findings but also build credibility with regulators, sponsors, and participants.
