Sponsor monitoring- Clinical Trials

It is an important oversight process to ensure quality, compliance,and subject safety. Monitors may be employees of the sponsor’s medical staff or a contract research organization, or may be independent contractors. In each case, they represent the sponsor, and visit investigator sites regularly, perhaps every four to eight weeks. They examine subject records in detail and verify that the correct information was transferred to the clinical trial case report forms a process called source data verification. During their site visits, monitors also examine administrative and regulatory documents, including drug supply and dosing records, adverse events documentation and reporting, the informed consent process,and communications between the sponsor company and investigator and between the investigator and IRB. In short, the activities of clinical trial monitors are designed to ensure that all elements of the protocol are being followed. In addition, monitors examine the appropriateness of the qualifications, training, and training records of all site staff involved with the trial, and they communicate changes in site personnel to the sponsor company’s oversight team. Following the completion of a site monitoring visit, the monitor meets with the site staff to review findings and discuss (agree upon) corrections in data or improvements in processes, if needed. Monitors are expected to write a formal
monitoring report promptly after each visit. Reports are sent to the sponsor company’s medical department, which reviews the reports. When necessary, that department’s clinical research associates and physicians recommend remedial action. Regular monitoring ensures continued contact with an investigator site to keep
the sponsor company aware of the site’s safety and compliance status. Periodically, information from many monitoring visits and reports is gathered and analyzed for common problems. When problems are detected, special site- or trial-specific counseling and training is initiated.