Sponsor-Investigators: Force the Formality

Sponsor-Investigators are uniquely dedicated and invested in clinical research. In a previous blog post, IMARC described how Sponsor-Investigators have to wear two hats and follow two sets of regulations.

The Sponsor is responsible for the following (21 CFR 312.50 and 21 CFR 812.40):

• Selecting qualified investigators
• Providing investigators with the information they need to conduct an investigation properly
• Ensuring proper monitoring of the investigation
• Ensuring that IRB review and approval are obtained
• Ensuring the investigation is conducting in accordance with the general investigational plan
• Maintaining an effective IND/IDE
• Ensuring FDA, all participating investigators, and IRB are promptly informed of significant new adverse events

The Investigator is responsible for the following (21 CFR 312.60 and 21 CFR 812.100):

• Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations
• Protecting the rights, safety, and welfare of subjects
• Controlling drugs/devices under investigation
• Obtaining informed consent of each human subject, in accordance with 21 CFR 50.

But what happens when the Sponsor is the Investigator? How does the Sponsor provide themselves with the information needed to conduct an investigation properly? How does the Sponsor inform themselves of significant new adverse events? How does the Sponsor ensure they are following the investigational plan? While there are no formal guidance documents from FDA at this time on this topic specifically, IMARC has worked with many Sponsor-Investigator studies, and we have learned one of the greatest tips: Force the Formality.

Forcing the formality of the Sponsor-Investigator relationship can be accomplished through good documentation practices and consideration of all required responsibilities. This formality can manifest itself in many different ways in order to achieve the objectives of meeting the federal regulations, the investigator agreement, the investigational plan, and the requirements of the IRB (See video on FAIR Shake).

One example of forcing the formality is to create separately maintained documentation, such as regulatory binders, for the Sponsor and for the Investigator. The formality could also be completed through the creation of additional procedures for the Sponsor-Investigator and study team to follow. For instance, a procedure could be created to define the notification and documentation practice of issues that arise during the study. Specifically, this could involve the notification process for adverse events or documenting protocol amendment training for study personnel. In addition, a skilled monitor can be of great assistance to ensure all requirements are met for both the Sponsor and the Investigator.

Please share your thoughts on other strategies to Force the Formality of Sponsor-Investigators!

Photo Credit: Steve White