The purpose of trial monitoring is to ensure that:

● The rights and well-being of the trial participants are protected,
● The reported trial data are accurate, complete and verifiable from source documents,
● 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, the product's known safety profile, 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 lower risk research.  

Clinical Trials of Investigational Medicinal Products (CTIMPs) subject to the the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended (SI 2004/1031) and Medical Device studies subject to the Medical Device Regulations 2002, as amended (SI 2002/618) usually always require some degree of monitoring, determined by the outcome of the risk assessment.

Non-CTIMP studies may or may not require any monitoring. This will be determined by the co-sponsors at the time of confirming sponsorship.

There are four types of monitoring visit:

● Site initiation
● Routine
● Close out
● Triggered

Site initiation visit
During this visit the monitors will liaise with the study team and conduct training in the sponsor’s standard operating procedures (SOPs). They will also discuss the best practice with regards to documenting compliance with GCP and will provide advice on adhering to the various relevant legislation that surround clinical trials. If it’s easier, we are happy to combine this initial visit with any protocol based training you have, rather than having several group meetings.

Routine monitoring visits
This refers to any non-triggered monitoring visit between the initiation and close of the study site. The frequency and nature of these visits will vary greatly depending on the study (please see FAQ 9 for a guide).

Close out visit
At the end of a study a check of all documentation, confirmation of archiving arrangements and a check to ensure the drug accountability is carried out.

Triggered visit
These are rarer, ad-hoc visits that are conducted at the discretion of the study sponsor often after discussions with the Chief Investigator and the study team. They seek to find out the extent of any issues that have arisen during the study and ensure corrective and preventative action is put in place if appropriate.