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Clinical Trials Frequently Asked Questions

Clinical Trial Glossary
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Frequently asked questions: Investigators

The majority of 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 investigator. Additionally, no previous investigator experience is required to qualify.

Clinical trial investigators play an integral role in the development of new medicines and medical devices used to help combat disease, treat chronic and degenerative diseases, and improve the health of people worldwide. There is a continual need for physicians in private practice to join in the pursuit of advancing medicine as clinical trial investigators. Advantages of conducting clinical trials include:

  • Professional development: Be on the cutting edge of your therapeutic area of expertise, meet other investigators, exchange ideas, plan future collaborations, and work with investigational medications and processes that are not yet approved by the FDA.
  • Professional recognition: Use your role as an investigator to co-author articles for publication and be recognized as a thought leader within the medical community.
  • Personal satisfaction: Offer your patients new medical treatments that may only be available through participation in clinical trials
  • New revenue stream: Add additional revenue to your medical practice, based on compensation provided by sponsors for your time spent conducting clinical trials.
  • Role in the advancement of medicine: Be a leader in your field by potentially bringing breakthrough drugs and medical devices - products that could impact the health of people around the world - to market.

You must have a basic understanding of good clinical practice (GCP) before you can participate as a clinical trial investigator. GCP refers to the principles and processes investigators worldwide are expected to follow. Good clinical practices are in place to ensure the safety and privacy of study participants. You will also need a thorough understanding of the principles of conducting clinical trials as well as the ethical and regulatory requirements.

You can learn more about GCP and how to become a certified investigator through the Academy of Pharmaceutical Physicians and Investigators. However, certification is not required to become a clinical trial investigator. The Drug Information Association is also a good resource.

The most important factor in determining if you are a good fit for overseeing clinical trials is a thorough understanding of the commitment needed to conduct a clinical trial. Many physicians find that being an investigator can be a challenging, but rewarding, experience.

When considering a specific trial, you may want to ask yourself:

  • Does this trial fit my patient population?
  • Is there an adequate patient population to meet enrollment goals?
  • Do I have the necessary equipment to conduct this trial?
  • Does my practice have the ability to store investigational products properly?
  • Do I have adequate staff to perform the responsibilities of this trial?
  • What would be the compensation to me for participating?
  • 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. You will probably want someone to handle that for you, most likely someone who is already on your staff. GCP training will provide tips for incorporating a clinical trial into your day-to-day practice.

Generally, you have indemnification against actions stemming from a clinical trial as long as you strictly adhere to the protocol and the clinical trial agreement as well as exercise reasonable medical judgment. You should be prepared to provide proof of malpractice insurance to the study sponsor or to the sponsor's representative. However, your participation in a clinical trial typically does not have an impact on your insurance premiums.

If you are selected, you will need to review several forms that correspond to the study, including confidentiality agreements, a study synopsis or protocol and an investigator's brochure. Later, your site will be visited by a clinical research associate (CRA) to assess your site's suitability for the trial and your ability to enroll patients in the trial.

An investigator ensures that a study is conducted according to the:

  • Protocol
  • Signed statement of investigator (Form FDA 1572)
  • Applicable regulations

An investigator is also responsible for:

  • Protecting the rights, safety and welfare of all study participants
  • Controlling and accounting for the drugs being studied/stored at the study site
  • Obtaining the informed consent of each study participant

An investigator administers the study drug only to participants under his or her personal supervision or under the supervision of a subinvestigator responsible to the investigator. The investigator must not supply the investigational drug to any person not authorized to receive it.

If the investigational drug is subject to the Controlled Substances Act, the investigator must take adequate precautions. This includes storage of the investigational drug in a securely locked, substantially constructed enclosure or cabinet with limited access to prevent theft or diversion of the substance into illegal channels of distribution.

  • Progress reports: The investigator furnishes all reports to the study sponsor or the sponsor's representative. The results are collected, evaluated and submitted to regulatory agencies.
  • Safety reports: An investigator promptly reports (to the sponsor) any adverse effect that may reasonably be regarded as caused by, or probably caused by, the study drug. If the adverse effect is alarming, the investigator must report the adverse effect immediately.
  • Final report: An investigator provides the sponsor with an adequate report shortly after completion of the investigator's participation in the study.
  • Financial disclosure reports: The investigator provides the sponsor or the sponsor's representative with sufficient and accurate financial information to allow the sponsor 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 is required to maintain adequate records of the disposition of the trial drug, including dates, quantity and use by participants. If the trial 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 required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the study for each individual trial participant. The case history for each individual shall document that informed consent was obtained prior to participation in the study.

In the United States, an investigator retains records for a period of two years following the date that a marketing application is approved for the drug and for the indication for which it was being investigated. If no application is filed, or if the application is not approved for the indication, the investigator must keep records until two years after the study is discontinued.

An investigator must, upon request from any properly authorized officer or employee of a regulatory agency, permit access to as well as 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 (to secure approval) or disapprove research. This review board serves an important role in the protection of the rights and welfare of study participants.

An investigator ensures that an IRB is responsible for the initial and continuing review and approval of the proposed clinical study. The investigator also assures that he or she will promptly report to the IRB all changes in the research activity and any unanticipated problems involving risk to study participants or others. The investigator also promises 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.


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Information included in the Glossary is from Clinicaltrials.gov, which uses content from AIDSinfo, CenterWatch, Inc., ECRI, Eli Lilly and Company, MediStudy.com, Inc. and National Cancer Institute.