Can monitor clinical trial

While critical risks could be monitored any number of ways, including the types outlined above — On-site, Remote, and Centralized — the end effort is more often a combination of these methodologies. All three clinical trial monitoring methods can be used in concert for effective oversight, monitoring and for the protection of data integrity and patient safety.

The FDA has issued three guidances on the use of risk-based monitoring in recent years. This guidance centers on sponsor oversight and study conduct.

The end aim is to improve participant protections while improving data integrity. Specifically, this guidance covers how sponsors, CROs, and researchers can develop a monitoring approach. It involves the development of monitoring plans as well as how to communicate results. The most recent guidance from the FDA regarding risk-based monitoring came out in March In recent years, the European Medicines Agency EMA has also issued a series of guidances and papers on risk-based quality management.

They describe quality controls as being a potential part of a centralized approach to ensure that submitted documents and clinical data checks are in order. Remote access became critical for continuing clinical trials that were in progress and preserving subject safety throughout this difficult time. Monitors must be appointed by the sponsor. A study monitor must be properly trained with the scientific and technical knowledge to adequately assess the activities of the professional clinical research team.

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.

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.

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. 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. At its core, study monitoring is a quality assurance role.

In such a case the medical monitor is contacted to figure out whether the subject must right away be removed from the trial, and if so, what procedures e. Numerous clinical trial sites participating in the study report to the medical monitor a substantial increase in blood pressure for various subjects enrolled in the clinical trial. The medical monitor can further propose that the study protocol be amended to exclude patients with a history of high blood pressure.

To become a medical monitor, you must strongly consider getting specialized training related to clinical trials and the pharmaceutical industry. At the James Lind Institute we offer multiple online programs that will help you to become a medical monitor. This program covers all important aspects of the job profile of a Medical Monitor and is highly accepted in the industry.

To know more about this internationally accredited online program visit the following link: Medical Monitor Training. Related posts:.