FDA Guidance on Clinical Investigator Roles and Responsibilities

  • By: Staff Editor
  • Date: January 25, 2017
  • Source:
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FDA Guidance on Clinical Investigator Roles and Responsibilities

Investigators conducting the clinical trials should meet all research expectations including FDA requirements and Good Clinical Practice (GCP) guidelines. Investigators must be diligent throughout the conduct of the trial from designing the protocol, determining which trials to perform, during the conduct and after completion of the study.

The FDA guidance document offers an outline of the responsibilities of an individual who conducts a clinical study of a drug, biological product, or medical device. The purpose of this regulatory guidance is to aid investigators better understand their responsibilities with respect to protecting the rights, safety and welfare of study subjects involved in clinical investigation.

Investigator Responsibilities Overview

The FDA emphases on the following four areas while evaluating the competency of supervision by an investigator:

Appropriate Assignment of Study-Related Tasks:

The investigator should ensure that an individual is qualified by education, training, and experience to perform the delegated task.

Sufficient Training for the Study Staff:

The investigator should ensure that there is adequate training for all the personnel involved in the conduct of the clinical trial.

Adequate Control of the Conduct of an Ongoing Clinical Trial:

FDA considers the following factors may affect the capability of an investigator to deliver adequate supervision of the conduct of an ongoing clinical research study at the investigator’s site:

  • Inexperienced study staff
  • Demanding workload for study staff
  • Complex clinical trials
  • Large number of study subjects enrolled at a site
  • A subject population that is extremely ill
  • Performing multiple studies concurrently
  • Conducting a study from a distant location

Investigator’s Duties for Oversight of Other Parties Involved in Conduct of a Clinical Trial:

The guidance outline the responsibilities of the investigator for supervising the study tasks performed by third parties even though they are not direct employ during the conduct of the study.

The guidance also details the responsibilities of the investigator for protecting the rights, safety, and welfare of the human subjects involved in the trial.

Related Training:

GCP and FDA Regulations with regard to Investigator Responsibility

Investigator Initiated (Sponsored) Trials

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