In all clinical trials, monitoring visits have to be conducted at the participating sites to ensure adherence to the protocol and all trial regulations and guidelines.
The frequency and type of monitoring visits depends on the phase of the trial, its complexity, the duration of treatment, the rate of patient enrolment and the percentage of source document verification.
Cardialysis offers four types of monitoring visits.
Pre-study visits or telephone calls are made to ensure that the participating sites meet the trial-specific requirements and Good Clinical Practice (GCP) guidelines. This initial contact is also important for establishing good site collaboration and for detecting and solving any problems in advance.
A well-organised initiation visit to a qualified site results in greater compliance of the investigator and staff and helps to ensure a successful trial programme. Cardialysis offers the advantage of a long-term relationship with many investigators; a large number of sites are already familiar with Cardialysis procedures.
Although the costs of monitoring are considerable in every clinical trial, good monitoring helps to reduce costs elsewhere. Good monitoring reduces the amount of edit queries, improves the total quality of the data and increases the percentage of patients completing the trial.
In a close-out visit, the Cardialysis Clinical Research Associate (CRA) visits the site to ensure the completeness of the Investigator Site File and all trial documents, including the regulatory documents. It is the responsibility of the CRA to solve all edit queries and to ensure that all data are complete before the close-out visit is performed.