<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&amp;ev=PageView&amp;noscript=1">
blog-hero.jpg
Compliance In Focus
Posted by Danielle Sas on Thu, Jul 31, 2014

Do you know the Sponsor - Investigator Role in Clinical Trials?

When the words “Clinical Research Trial” are heard, many questions may come to one’s mind.Do you know the Sponsor  Investigator Role in Clinical Trials What is being tested?  What is involved? Where will it be taking place? Who came up with the trial? Who is paying for it? What doctors are participating? Many of these answers for an Investigational Device (IDE) clinical research trial can be found on ClinicalTrals.gov.

As far as the questions “Who came up with the trial”, “What doctors are participating” and “Who is paying for it”, there are a couple of answers. A Sponsor is a person who initiates an investigation, but who does not actually conduct the trial. Some examples of Sponsors of clinical trials are as follows:

  • Government Agencies- National Institutes of Health (NIH) or the Department of Veteran's Affairs (VA)
  • Industry- Pharmaceutical, Biotechnology or Medical Devices companies

In addition, when an individual both initiates and actually conducts the trial, this individual is a
Sponsor-Investigator. This type of trial is also known as an Investigator Initiated IDE. Some examples of Sponsor-Investigators that conduct clinical trials are as follows: 

  • Individuals- Physicians, Professors, or Researchers

In general, for any IDE clinical research trial, the Sponsor of the study is responsible for securing compliance with the signed agreement, the protocol or investigational plan, the Food and Drug Administration (FDA) and the Institutional Review Board (IRB) according to 21 CRF 812.46. The Investigator at a site where a trial is being conducted is responsible for being compliant with the signed agreement, the protocol, and the FDA regulations according to 21 CRF 812.100.

Things can become slightly tricky during the conduction of a Sponsor-Investigator clinical trial where the physician sponsors and conducts his or her own clinical research trial at the facility where he or she is employed. The physician must then take on the responsibilities of the both the Sponsor and the Investigator.

 Some of the responsibilities of the Sponsor include:

  • Initially submit an IDE application to the FDA. 21 CRF 812.25
  • Select Investigators qualified by training and experience. 21 CRF 812.43
  • Select Monitors qualified by training and experience. 21 CRF 812.43
  • Submit changes to the investigational plan to the FDA throughout the study. 21 CRF 812.35
  • Ensure the Investigators are compliant with the agreement, protocol, FDA and IRB. 21 CRF 812.46
  • Report Unanticipated adverse device effects (UADE) to the FDA. 21 CRF 812.150
  • Maintain accurate, complete and current records. 21CRF 812.140
  • Submit reports regularly within the required timeframes to the FDA. 21 CRF 812.150

Some of the responsibilities of the Investigator at a site include:

  • Await FDA and IRB approval before allowing subjects to participate. 21 CRF 812.110
  • Be compliant with the agreement, protocol, FDA and IRB. 21 CRF 812.110
  • Maintain, control and supervise the use of the investigational devices. 21 CRF.100, 21 CRF 812.110
  • Ensure informed consent is obtained properly for all participants. 21 CRF.100
  • Provide disclosure of financial interest to the Sponsor. 21 CRF 812.110
  • Report unanticipated adverse device effects (UADEs) to the Sponsor. 21 CRF 812.150
  • Maintain accurate, complete and current records. 21CRF 812.140
  • Submit reports regularly within the required timeframes to the Sponsor and IRB. 21 CRF 812.150

During a trial where there is a separate Sponsor and Investigator involved, the role of each is spelled out in the FDA regulations. As noted in a recent whitepaper issued by IMARC, many of the responsibilities for the Sponsor and the Investigator overlap with each other, but other responsibilities are role specific.   As a physician that Sponsors a trial and is also the Investigator, he or she must know the responsibilities of both roles and be able to comply with all the FDA regulations regarding an IDE.  There are many intricacies with making sure all documentation is probably submitted to both the FDA and IRB. Selecting experienced Research Coordinators and Monitors can assist the physician in stepping back to look at the “bigger picture”, ensuring that he or she is meeting the requirements of both the Sponsor and the Investigator. 

IMARC monitors have the experience and can provide the training on the conduction of a Sponsor-Investigator clinical research trial. For more information please check out our website or give us a call!

Photo Credit:Yuya Tamai 

PSIDE Guide

 

 

Topics: Sponsor- Investigator Role, IMARC Research, Clinical Monitoring

imarc

Posts by Topic:

All