Even when you entrust the details of your clinical trials to an established professional testing facility, you still remain responsible for your study as a study sponsor. All clinical trials must be monitored, and monitoring is the responsibility of the study sponsor.
Study monitoring by sponsors is required by the principles of Good Clinical Practice (GCP) as recognized by both the US Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The study monitor works closely with the investigator in overseeing most aspects of a clinical trial.
Monitors must be appointed by the sponsor. Monitors could be a member of the sponsor’s own staff or a hired professional. A study monitor must be properly trained with the scientific and technical knowledge to adequately assess the activities of the professional clinical research team.
Not only must the monitor be familiar with the test product itself, but they must also have a keen familiarity with the study protocol, the accompanying documentation, the sponsor’s standard operating procedures, principles of GCP and relevant regulation. Because he or she will be a key avenue of communication between the study sponsor and the research team, the study monitor should have a good working relationship with professional colleagues of both parties.
Details of the study monitor’s role can be found in the FDA and ICH Links above.
Since clinical trials are human in-use studies, attention to trial subjects’ safety and well-being is paramount. In addition to the study protocol, the study monitor must review all information and documentation provided to study subjects and be particularly attentive to product use instructions and the language of the Informed Consent Form (ICF). An improperly-drafted ICF can result in a panel of subjects whose consent could be deemed ineffective.
Under the umbrella of human rights, the monitor’s obligations extend even further. They must ensure that the study investigator’s credentials and qualifications are adequate to safely conduct the study, that the hosting facility is clean and secure and that subjects can contact a member of the professional clinical testing team at any time throughout the study.
Facilities & product handling
Some aspects of the facility contribute to the protection of human rights in clinical studies. There are other factors, stemming from the facility itself, that can influence study procedures. These factors include whether or not the facility is adequate in size and appointed with proper instrumentation to carry out the protocol and whether it is open and staffed when subjects can conveniently make their scheduled visits.
Monitors must also ensure that the sponsor’s test product can be appropriately stored on-site at the testing facility. Locked storage areas should be available and refrigerated if necessary. Additionally, the facility should have adequate provision for disposing or destroying unused test product after the study has ended.
Documentation & data integrity
At its core, study monitoring is a quality assurance role. Communication, informed consent and facility inspections are all critical requirements. Similarly, documentation of study data is an equally vital and practical aspect of a successful and compliant clinical study.
Throughout the course of data collection, the monitor is accountable for seeing that testing facility staff carry out all protocol procedures correctly. These duties consist of creating, assembling and managing documentation and data, as well as properly including data source verification and any required reporting.
After every interaction with the testing facility staff, the study monitor is responsible for reporting his or her observations and actions to the study sponsor. Regardless of whether or not the monitor is a member of the sponsor’s staff or a hired professional monitor, these reports are a required component of the study records. More importantly, they help the sponsor stay informed with objective information to support decision-making for both current and future studies.
Regulations and guidelines are always changing in clinical research. An established professional clinical testing facility can help you stay up-to-date with news about trial monitoring and other sponsor requirements. CPT Labs is well-informed about FDA’s recent changes to the Sunscreen Monograph and well-equipped to help sponsors understand how the new regulations influence monitoring requirements for photobiology studies.