Clinical Trial Investigator

A clinical trial investigator is the person responsible for the conduct of the clinical trial at a trial site. If the clinical trial is conducted by team of individuals at the trial site, then the investigator is the responsible leader of the team and is known as the Principal Investigator.

Clinical Trial Investigator Qualifications

According to GCP guidelines, an investigator should:

  • Be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial
  • Meet all the qualifications specified by the applicable regulatory requirements
  • Provide evidence of such qualifications through up-to-date curriculum vitae or other relevant documentation requested by the sponsor, the IRB/IEC, and the regulatory authority.
Clinical Trial Principal Investigator Responsibilities

The Principal Investigator (PI) is responsible for:

  • The conduct of the study at his/her site
  • The training of personnel that have designated responsibilities to the study
  • The actions of these designated individuals as pertains to the conduct of the study

It is the investigator's responsibility to assure:

  • The adequate protection of the rights and safety of human subjects
  • The integrity of the scientific testing and validity of the data
Clinical Trial Investigator Activities

The investigator should

  • Personally conduct or supervise the trial in compliance with the signed Protocol and any amendments
  • Personally conduct or supervise the trial in compliance with the applicable regulations and GCP
  • Personally conduct or supervise the trial with the IRB
  • Read and understand all related literature
  • Be aware of potential risks and "side effects"
  • Ensure all study staff are informed about obligations
  • Protect rights, safety and welfare of subjects
  • Complete a CRF for each subject in a timely manner
  • Assure initial and continuing review by a regulatory-compliant IRB
ComplianceOnline training for clinical trial investigators

Responsibilities of a Principal Investigator in Clinical Trials: What you Must Do to Ensure Trial Compliance

Webinar discusses role and responsibilities of clinical trial investigator and the legal and regulatory requirements to follow for Good Clinical Practices (GCP)

Principal Investigator responsibility in Research Involving Human Subjects: The International Conference on Harmonization (ICH) view

This webinar provides invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.

Investigator responsibility/Legal commitment in drug and device clinical research: the reality

To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly.

Why investigators often lose money in conducting sponsored clinical trials

Webinar presents a proven process for investigators to address common deficiencies with respect to costs associated with clinical investigator site requirements for study conduct.

GCP and FDA Regulations with regard to Investigator Responsibility - How to get your PI more involved in the clinical Research process

This CGP compliance Webinar discusses the investigator role and responsibilities in clinical research process and highlights the ways to involve effectively the Principal Investigator in clinical research process.

GCP violations and Site Mistakes commonly found During a FDA Investigator Site Inspection/Audit and how to avoid them

This GCP training guides you through key component identification of a good GCP audit program, Investigator awareness, Protocol adherence, The Informed Consent process, Evaluation of subject selection, Inclusion/exclusion criteria, data sampling and audit findings assessments.