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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.

Types of clinical trials:

  • Prevention trials

  • Screening trials

  • Case control studies

  • Cohort studies

  • Cross sectional studies

Figure no. 1: clinical trial team flowchart.

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.

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Figure no. 2: Roles of clinical research controller.

Figure no. 3: Responsibilities of clinical research controller.

Figure no. 3: Responsibilities of clinical research controller.

Figure no. 6: Responsibilities of data manager.

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

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