Monitoring / CRAs
The conduction of the clinical trial is a matter of sensitivity and safety.
he staff should be responsive enough to handle every situation on the clinical site. It is mandatory to monitor every change occurring on the site, whether it may be minor or major. Every event at the site and in the process can be sensitive. It may change the outcomes of the study. A person is required to exclusively monitor and manage the process of trial to ensure the safety of the subject as well as the staff involved in the trial. A Clinical Research Associate (CRA) is known as trial monitor or clinical research scientist who is employed by either a pharmaceutical company or sponsor companies of clinical trials or by Contract Research Organizations (CROs) that conduct clinical trials on behalf of the sponsor companies.
Clinical trials test the safety and efficiency of new medicines. The trials can take several years to complete, and it can be years before the results are precise. The tests are to find out things like the benefits, risks and side-effects of the medicine.
Clinical trials may be carried out on patients with a disease, at various phases, and studies conducted after the launching of new medicine to monitor its side-effects and safety. CRAs are involved in all stages of the clinical trial, including setting up, identifying an investigation site, initiating, monitoring and closing the trial upon completion or termination. An organised, flexible Clinical Research Associate shall oversee clinical trials judiciously and responsibly. The Clinical Research Associate develops and outlines the clinical trial protocols, train site staff where the clinical trial will be conducted, establish trial sites and manage Investigational Product (IP) and trial materials. The Clinical Research Associate manages multiple aspects of the subjects’ welfare. He or she conducts regular site visits, start his/her program by generating and distributing internal and external newsletters, then work on the project and research of the topic to gain knowledge and better ideas and overview of the subject, and finally prepare final reports and meet with interested parties regarding all trial aspects. As a Clinical Research Associate, he or she may be involved in all stages of clinical research, and all the stages of a trial. Clinical trials usually take place in hospitals or clinics. The CRA may regularly travel between several testing sites. They have a detailed description of the work. However, their primary responsibility is to ensure that the safety, rights and well-being of human subjects participating in clinical trials are protected. A Clinical Research Associate (CRA) acts as the primary mode of communication between sponsors and the clinical trial site.
Role and Responsibilities of CRA:
- Creating and writing detailed trial protocols, and presenting them to the head committee.
- Identifying, checking and establishing trial sites.
- Training site staff on protocol requirements, therapeutic areas, proper source documentation and case report form completion.
- Coordinating with ethics committee regarding safety, rights and well-being of trial subjects.
- Ordering, managing and noting IP and trial materials.
- Documenting IP dispensing, inventory and reconciliation.
- Protecting human subjects’ confidentiality and staying updated on their information.
- Coordinating project meetings, conducting regular site visits, and writing visit reports.
- Working upon the action plans for sites not meeting expectations.
- Being liable to regulatory authorities.
- Ensuring compliance with SOPs.
- Monitoring clinical trial sites to make sure that the guidelines, study protocol and applicable regulations are being followed
- Ensuring that qualified personnel are working as site staff and that they are adequately trained
- Ensuring that the data collected is detailed, accurate and verifiable.
- Managing all the clinical trial site payments and handle any ongoing negotiations
- Managing and Ensuring that the trial site has the acceptable infrastructure and that it continues to remain so throughout the trial
- Being a mentor to the site staff and provide them with continuous support and guidance
- Ensuring appropriate collection of study documents and archival
- Identifying, interviewing and selecting an investigator who will be responsible for the conduct of the trial at the trial site.
- Dealing with doctors, investigators and consultants on conducting the trial.
- Setting up the trial sites that includes ensuring the availablility of the trial materials at each centre, including the trial drug often known as the investigational medicinal product.
- Verifying that investigator and investigator’s team are adequately trained and comply with the protocol.
- Monitoring the trial throughout specific duration involving various monitoring visit to the trial sites.
- Source data verification
- Informed consent form review, case report form (CRF) ,adverse event review , and investigational drug accountability.
- Keeping the track of all unused trial supplies.
The skills possessed by the CRA are-
- Excellent communication skills (both written and oral)
- Ability to build effective relationships with staff
- Managing and encouraging the trial staff
- Being observant and keeping an eye for detail
- Ability to multi-task
- Good organisational, administrative and IT skills – since the job involves a lot of recording and documentation of information through computerised processes such as electronic data capture and clinical trial management systems.
- A high level of scientific knowledge
- An interest in fighting disease with a logical and methodical approach
- Planning and organizational skills to manage trials
- Patience – it can take years to test a drug fully, so it is important for a CRA to be patient.
- Teamwork skills- it can help to work with other Scientists, Doctors and other healthcare professionals while having the ability to work well on your own
- Willingness to travel to investigation sites
- Confidence, leadership and time-management skills
- Ability to prioritise and manage workload effectively.
CRA plays an important role in the smooth working of the clinical trial. A clear mode of communication is required with the proficient skills, and that is what for the CRA is appointed. The CRA monitors the whole site and the functioning of the clinical trial in adherence to the regulations and protocol.