GCP Monitoring of Clinical Research

The purpose of trial monitoring is to ensure that:

1. The rights and well-being of the trial participants are protected,
2. The reported trial data are accurate, complete and verifiable from source documents,
3. The conduct of the trial is in compliance with the currently approved SOPs/guidelines/protocol/amendments, with GCP and with the applicable regulatory requirements.

Monitoring procedures will be determined for individual research studies by risk assessment, based on, the nature of the investigational medicinal product(s), the product(s) known safety profile(s), the type of study (phase I, II, III or IV), the vulnerability of the participants, potential for high withdrawal rate and complexity of the protocol. Research perceived to be high risk will be subject to more frequent and more intense monitoring than research judged to be low risk.  

The definition of monitoring will include all those procedures that are required to oversee the progress of research and to ensure that it is conducted, recorded and reported in accordance with the SOPs, guidelines, protocol, the principles of GCP and the applicable statutory and regulatory requirements.