Who Is a Principal Investigator?

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The person who is in charge of a clinical trial or a research grant is called the principal investigator (PI), and it’s a big responsibility.[i] To put it simply, this is the person who is accountable if anything goes wrong; the one who could have a sign on the desk that says “The buck stops here.” Not only do these professionals ensure the ultimate integrity of the scientific study, they also maintain public trust in the research.[ii] So what does this enormous job cover?

The principal investigator is a person who by training, education, and experience is qualified to run all aspects of a clinical trial. They don’t have to be a doctor, but if they aren’t, the project must have a qualified doctor as a sub investigator. It’s helpful to divide the many responsibilities of the principal investigator into categories to clarify this vital role in medical research.

Research Staff

The principal investigator has the responsibility for the staff who run the clinical trial:

  • By hiring people to work for the trial who have the correct education, training, experience, and credentials for the job
  • Ongoing training of research staff to work in the trial
  • Make sure there are no conflicts of interest with team members
  • Meet with team members on a regular basis
  • Supervise the research staff and make sure protocol is followed at all times[iii]

Research Participants

In addition, the principal investigator must protect the participants of the clinical trial:

  • Make sure the participants have given their informed consent to be part of the trial
  • Oversee physical examinations of participants prior to the trial
  • Oversee the general safety of the participants during the trial
  • Be sure that participants understand the experimental nature of the drugs
  • Keep track and ensure that drugs are distributed in accordance with the protocol of the trial[iv]

Documentation

Record keeping and documentation is an important part of the principal investigator’s responsibility also In this role, he or she must:

  • Make sure all records are complete, in compliance, and accessible to the health and regulatory authorities such as the Food and Drug Administration (FDA)
  • Sign Form FDA 1572 (Statement of Investigator)[v] to take responsibility for any noncompliance or misconduct of anyone involved in the study
  • Maintain careful study records for at least two years or as long as the protocol requires
  • Keep accurate, excellent safety records
  • Report anything adverse; serious events must be immediately reported
  • Keep detailed financial records, including necessary disclosures if anything changes during the trial
  • Thoroughly read and understand all correspondence from the Institutional Review Board and implement directives
  • Make sure that there is approval and compliance with the Institutional Review Board throughout the trial
  • Put together a final report to the study sponsor[vi]

The principal investigator also has the direct responsibility to make sure that the trials run smoothly. This includes doing some practice, or dry runs to check out all the details of the study.[vii] Without the detailed and careful oversight of the principal investigator, clinical trials wouldn’t run effectively and efficiently. The PI has the duty to ensure the scientific integrity of the project as well as the safety of the volunteers involved in the clinical trial. It’s a huge responsibility, but the rewards in advancing medical science through clinical trials make it a worthwhile and necessary job.

To learn more about melanoma clinical trials, visit BMSStudyConnect.com. The site provides patients and caregivers with information about how clinical trials work and how they might be part of making sure new medicines are effective and safe.

[i] https://www.cancer.gov/publications/dictionaries/cancer-terms/def/principal-investigator

[ii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122254/

[iii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122254/, https://www.fda.gov/media/77765/download

[iv] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122254/, https://www.fda.gov/media/77765/download

[v] https://www.fda.gov/media/78830/download

[vi] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122254/, https://www.fda.gov/media/77765/download

[vii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122254/, https://www.fda.gov/media/77765/download