Investigator FAQ

Most clinical trial investigators are physicians in private practice. You do not need to be associated with a medical school or a teaching hospital to qualify as a clinical trial investigator. No previous experience as an investigator is needed to qualify.

In a clinical trial, an investigator’s role is to ensure that a study is conducted according to the signed investigator statement, the investigational plan and the applicable regulations.

To become an investigator, you should be familiar with the basics of good clinical practice (GCP). These principles and processes are followed to protect participant safety and privacy. You will also need a thorough understanding of the principles of conducting clinical trials and the ethical and regulatory requirements. Learn more at the Academy of Physicians in Clinical Research’s website.

Many investigators find participation challenging, but very rewarding. Understanding the time and resource commitment necessary to participate in a trial is one of the most important factors in deciding whether or not to become an investigator. Other aspects to consider about specific trials include:

• Does this trial fit my patient population?
• Is there an adequate patient population to meet enrollment goals?
• Is my practice able to properly store investigational agents?
• What are the potential pitfalls of this protocol? 
• What would be the compensation?
• Am I, along with my staff, committed to all that will be involved in this trial?

Clinical trials require a fair amount of management and documentation. Physicians may want to appoint someone on staff to handle those components of participation. GCP training will also provide tips for incorporating a clinical trial into your day-to-day practice.  All staff at your practice must be aware of the clinical research trials ongoing at your site in order to identify potential patients who can be given additional information about the trials.

Generally speaking, you have indemnification against actions stemming from a clinical trial as long as you strictly adhere to the protocol and the clinical trial agreement, and you exercise reasonable medical judgment. You should be prepared to provide proof of malpractice insurance to the sponsor or the sponsor’s representative; however, your participation in a clinical trial usually will not impact your premiums.

If you are selected, you will need to review other forms, including confidentiality agreements, study protocol and an investigator drug brochure (IDB) describing what is known about the study drug. Later, your site will be visited by a clinical research associate (CRA) to assess your commitment and your site’s suitability for the trial. Learn more about the process as an investigator.

An investigator administers the drug only to participants under the investigator’s personal supervision or under the supervision of a sub-investigator responsible to the investigator. The investigator must not supply the investigational drug to any person not authorized to receive it. All study drug must be kept in locked storage at the study site with limited access by only authorized staff members.

There are various reports that an investigator must provide within a clinical trial:

• Safety reports: An investigator promptly reports to the sponsor or the sponsor’s representative any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator must report the adverse effect immediately.
• Financial disclosure reports: The investigator provides the sponsor or the sponsor’s representative with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements. The clinical investigator should promptly update this information if any relevant changes occur during the course of the study and for one year following the completion of the study.

An investigator retains records for a period of two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is filed or if the application is not approved for such indication, until two years after the study is discontinued. 

An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity and use by participants. If the study is terminated, suspended, discontinued or completed, the investigator must return the unused supplies of the drug to the sponsor or otherwise provide for disposition of the unused supplies of the drug.

An investigator is also required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the study on each individual who was administered the investigational drug or employed as a control in the study. The case history for each individual shall document that informed consent was obtained prior to participation in the study.

An investigator must, upon request from any properly authorized officer or employee of a regulatory agency, at reasonable times, permit access to copy and verify any records or reports made by the investigator. The investigator is not required to divulge participant names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.

In the United States, an institutional review board (IRB) is a group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of study participants.

An investigator assures that an IRB is responsible for the initial and continuing review and approval of the proposed clinical study at their site. The investigator also assures that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to participants or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to participants.