Conducting a clinical trial involves much more than just a physician and a patient. The skills of many experts are required in the design and running of a clinical trial. Such skills include; trial coordination, data processing, regulatory management, medical research, and many more. The people who play these roles are vital components in successfully initiating and conducting a clinical trial1.
A successful clinical trial is a product of different personnel, all working together on various tasks at the same time to ensure everything comes together. Matching individuals with appropriate tasks ensures the proper use of the program’s resources and that the team members enjoy and remain challenged by their roles.2 Some of the roles of the core team members involved in clinical trials will be discussed below.
The principal investigator is the lead personnel at the clinical trial site and oversees the conduct of the clinical trial. The PI is most times a medical doctor or a faculty member when the clinical trial is conducted at an academic institution. The PI’s leadership role is the bedrock of any successful clinical trial. Principal Investigators who are doctors can provide their patients with the opportunity to participate in the study, while also assisting pharmaceutical companies in evaluating the safety and efficacy of this investigational treatments3.
The Principal Investigator is responsible for all trial-related activity at the research site. These responsibilities include:
In summary, the Principal Investigator is responsible for ensuring the study is conducted in accordance with the requirements of the national regulatory agency and Good Clinical Practice.
A Sub-Investigator is any member of the study team designated and directed by the Principal Investigator to perform key roles and make crucial decisions related to the trial, all of which must comply with the ethical conduct of the study7. The Sub-Investigator may perform some of the Principal Investigator functions, but they do not bear the primary responsibility of the study. A Sub-Investigator can play a number of roles which include:
A Clinical Research Associate plays a crucial research support role that involves handling the daily conduct of a study. CRAs may either be directly employed by the sponsors7 or the Contract Research Organizations (CROs)8. They are also referred to as Clinical Trial Monitors and have a broad work description. Their main responsibility, however, is to ensure the protection of the rights, wellbeing, and safety of the study participants. CRAs act as the main communication link between the sponsors and the research sites.9 They set up, monitor, and close the clinical trial sites assigned to them.
Some of their common on-job responsibilities include:
The Regulatory Coordinator helps in the establishment of a legal basis for the approval of new interventions.10 Research Coordinators are responsible for preparing or amending the protocol document. They also submit new protocols, amendments, safety reports, and continuing reviews for assessment by the appropriate IRB. This role involves the collection of data from the trial and charting outcomes. It also involves filing compliance reports and coordinating with ethics boards concerning the acceptance process for new interventions11. The following tasks are also part of the roles of Regulatory Coordinators:
In addition to these, Regulatory Coordinators usually keep the delegation of authority logs for top personnel involved in the study.
The Research Nurse works hand-in-hand with the rest of the research team to make sure that every required procedure and visit take place in accordance with the guidelines specified in the protocol. They generally manage the enrollment of participants12 and ensure the conduct of the trial is compliant with the protocol and other regulatory requirements. Their roles include but is not limited to:
Although not every clinical trial institution employs research nurses, they play key roles in organizations where they are utilized.
The Clinical Data Manager is responsible for data management of a research study. They ensure the accurate recording of all the study’s statistical information and results. Clinical data managers ensure robust data quality and identify ways to improve processes by developing and executing data testing and analysis strategies.13 They ensure timely and accurate data entry into electronic databases or report forms.14 They also perform roles such as:
An extensive range of roles involved in conducting a successful clinical from the very first phase to the last. All of these diverse roles cannot be fulfilled by a single individual, and this is where the importance of building the right team comes in. The development and maintenance of a standard research team15 are crucial to the success of any clinical research program. It is important that the roles of each team member are well-defined. The team members must be committed to excellence, communicate effectively, and develop mutual respect for each member’s role.
The use of technology in clinical trial management also helps in making the research management process easier and more efficient. With our data-driven technology and the exemplary study team at ClinicalMatch1, we improve health outcomes and deliver innovative solutions to patients, physicians, PIs, and pharmaceutical companies.