The Clinical Trials Team - Roles & Responsibilities
In a research study, a clinical trial tests a new medical treatment or a new way of using an existing treatment to see whether it will be a better way to avoid and screen for diagnosing or treating a disease. Purpose of clinical trial:
A research study that is performed on individuals for evaluation of a medical, surgical, or behavioral intervention.
Clinical Research Careers
Clinical Research Associate (CRA)
Clinical Research Coordinator (CRC)
Drug Safety Monitor (PV)
Clinical Trial Assistant (CTA)
Clinical Research Nurse (CRN)
Medical Monitor (MM)
All Research Professionals (ICH GCP)
Types of clinical trials:
Prevention trials
Screening trials
Case control studies
Cohort studies
Cross sectional studies
Figure no. 1: clinical trial team flowchart
Clinical research trial team:
The success of a quality clinical research program is essential for developing and maintaining an impeccable clinical research trial team. It is the main component of a research program because total time and effort for conducting a clinical trial; nurses and data managers each contribute more than 30%. On the other hand, physician’s contribution to clinical research is only 9%.
Roles and Responsibilities of clinical trial personnel
Clinical research team:
Roles:
Participants are provided with information about the clinical trial.
The content of the informed consent is explained.
Reporting of adverse events or drug reactions.
report suspected misconduct.
Protect the integrity and confidentiality of records and data during the clinical study
Responsibilities:
Appropriate training
Following of GCP standard
Following required protocols
Investigator:
Roles:
• Following ethical principles.
• Provide education programs.
• Design and conduct clinical trials for policies and procedures.
• Refer to GCP course for training.
• Determines the scientific, technical, and administrative aspects of the research project.
Responsibilities:
• Conduction of trial, statement, protocol, and applicable regulations.
• Protection of rights and welfare of participants.
• Obtaining informed consent.
• Maintenance of proper records.
• Management of all safety reports and financial disclosure reports.
Figure no. 2: Roles of clinical research controller.
Figure no. 3: Responsibilities of clinical research controller.
Figure no. 6: Responsibilities of data manager.
Sponsor:
Roles:
Financial
Reputation
Legal
Responsibilities:
Selection of qualified investigators.
Ensures proper monitoring of the clinical trial.
References:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3092661/ - The Clinical Research Team
https://clinicaltrialpodcast.com/clinical-research/ - 15 Clinical Research Job Roles & Responsibilities (2021)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3051859/ - Clinical Investigator Responsibilities
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042393/ - How to engage stakeholders in research: design principles to support improvement