On-Site Monitoring

To ensure that:

(a) the rights and well-being of human subjects participating in the study are protected.
(b) the reported trial data is accurate, complete, and verifiable by source documents.

Remote Monitoring

To provide:

(a) Urgent response to questions from the sites regarding clinical research management and health related problems.
(b) Document and follow up these issues, in accordance with protocol and applicable regulations/guidelines
(c) Provide feed back to the investigator team about problems identified from regularly review all cases

Safety Monitoring

Safety monitoring helps ensure the safety and well being of the patients. Information sharing and discussion of the clinical management of cases help those working in the network to learn and improve the quality of care to patients involved in the studies.

Tracking

To ensure compliance with Good Clinical Practice (GCP), all site, patient and study activities must be documented. For example, some activities require documentation to be sent to Ethics Commitees for approval, or Federal Wide Assurance (FWA) approval to ensure any research study complies with US Federal Regulation for the protection of human subjects in research.

Clinical Research Support

Dedicated Adminstration, Accounting and IT departments support the activity of PHPT. The quality management system of PHPT has been ISO 9001 certified. We also have a dedicated translation team who provide document translations from English to Thai.

Data Management Centre

Patient data is collected by the medical teams at site and the clinical research assistants and sent to the data management centre in Chiang Mai. The centre currently processes all data collected at study sites through a double data entry system and uses data management applications to ensure data accuracy. Reports are produced reguarly on all ongoing studies to provide feedback to the medical teams at site and inform sponsors of the progress.

Drug Distribution Centre

The drug distribution centre is responsible for the distribution of ARV treatments to more than 2,000 patients in clinical studies and in the treament cohort.

HIV Laboratory

Our HIV dedicated laboratory based at the Faculty of Associated Medical Sciences (AMS), Chiang Mai University, is ISO 15189 accredited.

For more details on the HIV Laboratory please see this page.