Clinical trials are an important part of modern medicine since they help to create treatment strategies for disorders. They contribute in the detection, diagnosis, and prevention of disease, as well as supplying researchers with information on which medical treatments are effective and which are not.
Despite the increasing power of AI, predictive models, and laboratory testing, clinical trials remain vital for such research as they test medicines and other treatments in real world conditions. The resulting data is immensely helpful in the effort to develop effective protocols going forward.
Each trial is carefully structured to ensure that proper and unbiased treatment methodologies are followed. A well-developed clinical trial requires several key specialists working together to give a scientifically valid outcome, each of whom performs a set of specific tasks to assure the overall success of the venture.
Let’s take a look at the roles and responsibilities of the various individuals involved in a clinical trial.
Principal Investigator (PI):
The principal investigator can be seen as the team leader or individual in charge, tasked with overseeing the trial. As such, they spearhead the project and bear the most responsibility to ensure its completion.
At its core, the responsibilities of the PI are to ensure that the investigation statement and plan are followed according to the relevant regulations, while ensuring that the rights, safety, and well-being of the subjects is maintained. The PI is responsible for overseeing all parts of the clinical trials from start to finish in order to assure viable results and procedural compliance. In addition to understanding the science behind the trial, the PI must ensure that local laws, rules and regulations, as well as industry standards are all followed strictly.
Sub-Investigator (Sub-I) / Co-Investigator (Co-I):
The sub-investigator or co-investigator has a role which is similar to that of the PI, but is generally more focused on a specific aspect of the clinical trial. Often they are specialists in a certain field (e.g., psychology, neurology, cardiology, etc.), and are tasked with overseeing the screening of subjects, the implementation of protocols, the monitoring of subjects, and the performance of administrative and data collection activities.
While the principal investigator is tasked with overseeing the entire trial, the sub-investigator’s function is to oversee specific aspects of a trial. Communication between the principal investigator and their sub-investigators is paramount. Generally speaking, the sub-investigator performs critical study-related procedures and makes many key decisions during the course of their work. They are often designated to make medical judgments and other decisions on behalf of the principal investigator.
The regulatory coordinator position is tasked with ensuring that the clinical trial is ethical and legal, while remaining within the accepted framework. These responsibilities are essential for ensuring the safety of subjects for the duration of the trial. The regulatory coordinator is expected to prepare and compile all regulatory documents, and handle reporting.
Moreover, this type of coordinator often provides training or guidance to other members of the team, and also liaisons with sponsors or other relevant stakeholders. They are also in charge of monitoring the trial, ensuring regulatory compliance, and observing the conduct of team members to ensure that the process protocols are followed in accordance with the investigation statement and legal/regulatory limits.
The data coordinator’s main job is to ensure the timely, reliable and efficient compiling of any data or information gathered for the duration of the clinical trial. They are tasked with recording all data and coordinating with the investigators or research nurse regarding which pieces of data are to be collected and tracked.
They are also responsible for providing any necessary data to regulatory or monitoring agencies to ensure compliance. Lastly, they are required to prepare summaries or overviews both during the clinical trial and after its completion.
Research Coordinator / Research Nurse:
The research coordinator or research nurse manages daily activities and can come from a variety of backgrounds depending on the requirements of the trial. Over time, the traditional role of the research coordinator has expanded beyond clinical management to also include compliance, research administration, marketing, fiscal, and legal activities.
The research coordinator must be flexible, responsive, and able to make decisions regarding the running of a clinical trial. They must have strong communication and organizational skills, as well as the ability to work independently and excellent attention to detail.
Putting the team together
A successful clinical study necessitates collaboration across multiple key positions, each with its own set of responsibilities and functions. As the principal investigator and their sub-investigators oversee the trial, the regulatory coordinator ensures that all rules and regulations are followed. Meanwhile, the data coordinator makes sure that all information is collected properly, while the research coordinator runs the daily aspects of the clinical trial.
Clinical trials can appear complicated but they are based on strict scientific standards. A strong team, with clearly defined roles and responsibilities, can bring about a positive outcome for a well-designed trial, ultimately maximizing the efficacy of new treatment methodologies while minimizing potential risk to participants.
To learn how our team can help medical organizations complete clinical trials successfully in Thailand, contact Clinixir today.