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Investigators Frequently Asked Questions

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A clinical investigator’s role is pivotal in the development and advancement of new drugs. These frequently asked questions (FAQ) address issues regarding clinical trials and investigators.

 

Investigator FAQ

Who can become a clinical trial investigator?

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

Why should I consider becoming a clinical trial investigator?

Clinical investigators play an important role in the development of drugs, therapies and medical devices to combat disease, treat chronic and degenerative diseases, and improve the health of people throughout the world. Physicians in private practice are needed to join as investigators in these trials. By conducting clinical trials, you:

  • Remain at the cutting edge of your specific area of therapeutic interest
  • Gain recognition as a thought-leader within your professional community
  • Open opportunities for additional revenue for your practice
  • Offer your patients new treatments that may only be available through participation in clinical trials
  • Support the evolution of medicine
What do I need to know to become a clinical trial investigator?

You should be familiar with the basics of good clinical practice (GCP). These are the principles and processes that are followed for participant safety and privacy. You will also need a thorough understanding of the principles of conducting clinical trials and the ethical and regulatory requirements. You can learn about GCP and become a certified investigator through the Academy of Pharmaceutical Physicians and Investigators. Certification is not required to become a clinical trial investigator.

How do I know if clinical trial investigation is right for me?

The most important factor is that you have a thorough understanding of the commitment needed to participate in a clinical trial. Many investigators find participation a challenging, but very rewarding experience.

You may also want to ask these questions about specific trials:

  • Does this trial fit my patient population?
  • Is there an adequate patient population to meet enrollment goals?
  • Does my practice have the ability to properly store investigational agents?
  • What are the potential pitfalls of this protocol?
  • 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?
How do I incorporate clinical trial investigation into my practice?

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.

What liability do I have if I participate in a clinical trial?

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, 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. Generally, you have indemnification against actions stemming from a clinical trial as long as you strictly adhere to the protocol, the clinical trial agreement, and 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.

How do I get started as an investigator with PPD?

If you are interested in becoming a clinical trial investigator, you can get started by registering in our database. Just use our clinical trial investigator registration process. We are seeking both experienced and research-naïve investigators. You will be added to our investigator directory, making you eligible for clinical trial participation. You will be considered for any current or future clinical trials that match your specialty and trial indication interest.

What happens when I am selected to be a clinical trial investigator?

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 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.

What are the general responsibilities of a clinical trial investigator?

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

  • Signed investigator statement
  • Investigational plan
  • Applicable regulations

An investigator is also responsible for:

  • Protecting the rights, safety and welfare of study participants
  • Controlling the drugs under study

An investigator must obtain the informed consent of each study participant to whom the drug is administered.

What does an investigator need to know about control of a drug?

An investigator administers the drug only to participants under the investigator’s 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.

What about the handling of controlled substances?

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

What kinds of reports does an investigator provide?
  • Progress reports: The investigator furnishes all reports to the drug’s sponsor or the sponsor’s representative (for example, PPD); the results are collected, evaluated and submitted to regulatory agencies
  • 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
  • Final report: An investigator provides the sponsor or the sponsor’s representative 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 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.
What about recordkeeping and record retention?
  • Disposition of drug: 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.
  • Case histories: An investigator is 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.
  • Record retention: 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. Disposition of drug: 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 Case histories: An investigator is 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 Record retention: 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
What about inspection of records and reports?

An investigator must, upon request from any properly authorized officer or employee of a regulatory agency, at reasonable times, permit access to, and 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. What is an institutional review board?

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 participants.

How does an investigator work with an IRB?

An investigator assures 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 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.

What is a CRO?

A contract research organization (CRO) is a service organization that offers support to the pharmaceutical and biotechnology industries in the form of research services provided on a contractual basis. A CRO can provide such services as biopharmaceutical development, preclinical research, clinical research, and clinical trials management. Many, but not all, CROs specifically provide clinical study and clinical trial support for drugs and/or medical devices. CROs range from large, international, full-service organizations to small, niche specialty groups. CROs that specialize in clinical trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval, without the drug sponsor having to maintain a staff for these services.

What are EMA and FDA, and what are their roles in clinical trials?

Created by and for doctors, European Medical Association (EMA) is essentially a service organization.  To improve the quality of health care and medical working conditions in the European community, EMA primarily aims to:

  • Improve information
  • Improve transparency and comparison
  • Encourage collaboration and mobility

EMA’s objectives focus on the improvement of the medical profession in the European context.

  • To act in order to influence health policies according to practicing doctors’ priorities
  • To form a forum of doctors working in the European Union’s medical community
  • To provide its members with information and services that facilitate their professional activity
  • To contribute to the improvement of health care given to patients by helping its members keep abreast of the latest developments
  • To influence the development of health care in Europe by representing its members’ opinions

The U.S. Food and Drug Administration (FDA) is an agency of the U. S. Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products and cosmetics.

How do I budget for a study?

Various strategies could be used to budget for a prospective study ranging from a simple Excel spreadsheet to much more complicated methods. A suggestion would be to review each of the study visits and document what study procedures are required for that visit. This information is often available as part of the study protocol and is commonly called the “Visit Schedule.” Allocate a cost to each of the study visit procedures and add on any additional costs that may be incurred as a result of this study. This will give you a rough estimate of what the costs for the study will be. Most studies will have a payment schedule as part of the contract negotiation process and you can then compare your cost estimates to the payment schedule.

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