Clinical research associates, or CRAs, also referred to as trial monitors or clinical monitors are health-care professions performing various activities relating to medical research, especially clinical trials. These associates are capable of working in a range of settings such as medical research institutes, pharmaceutical companies as well as government agencies. The certification and education requirements that are necessary for the practice of a clinical research associate depend on the jurisdiction.
The major tasks that are conducted by a clinical research associate are defined by efficient clinical practice guidelines that have been set up to monitor clinical trials, for instance the ones that the International Conference on Harmonization of Technical Requirement for Registration of pharmaceuticals for Human USE (ICH) has elaborated.
The major task of independent auditors for CROs is the monitoring of clinical trials. A clinical research associate may be working directly with the community sponsoring the clinical trials, for an establishment of CRO in India or as an independent freelancer. Clinical research associates ensure that there is compliance with clinical trial protocols, check the activities being conducted on the clinical site, make visits to the site, establish communication with clinical research coordinators and review case report forms. CRAs also give assurance of the protection of rights, well-being and safety of the subjects of human study. In addition to that, clinical research associates must ensure that they verify and protect the scientific integrity of data that has been collected. They also need to correctly document and report any adverse events that occur.
Clinical research associates usually need to possess academic degrees in Life Sciences, along with having good knowledge of local regulations and good clinical practice.
Adequate monitoring of clinical trials is required to ensure the safety of subjects, quality of data as well as a good execution of the study. During each phase in clinical monitoring, clients are provided with complete, detailed reports following the completion of each clinical monitoring service in a timely manner.
The monitoring services that companies provide to clients include:
- Pre-study or qualification visit: A complete assessment of every clinical research site, the capability of the staff and evaluation of whether the site adheres to FDA regulations is initiated. It is also ensured if good clinical practices are taking place and how the trials are being conducted overall.
- Visit for initiating clinical monitoring: Clients are provided with complete initiation of clinical research sites. This is inclusive of review of regulatory documents, enrollment documents, protocol, case report forms, responsibilities for conducting clinical trials and investigational drugs.
- Visit for interim clinical monitoring: For ensuring of quality, ongoing clinical monitoring is conducted throughout the clinical trial. This includes activities such as eligibility verification, informed consent review, source documentation and case report form review, review and ongoing maintenance of regulatory documents, data retrieval as well as drug accountability and assessment of adherence to protocol.
All these aspects speak volumes about clinical monitoring systems.