Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Regulatory community, 

Who is considered the sponsor of a clinical investigation?  My understanding is that it's usually the manufacturer of a device who finances the study.  The manufacturer is ultimately responsible for the conduct of the study and it cannot be outsourced to a third-party (e.g. CRO).  However,  the business department in my company thinks otherwise.  But if we receive clinical investigation authorization from the regulatory agency with our name on it, does this mean we are by default the sponsor?   Can the sponsor ever be a party other than the manufacturer?  Perhaps, the term "sponsor" is more nuanced than I think.

Thanks. I would like to hear your insights.

The term "sponsor" is defined in 21 CFR Part 812.3(n).

------------------------------
Michael Wienholt
Owner & Principal Consultant
Raleigh NC
United States
------------------------------

Original Message:
Sent: 15-Jul-2019 11:59
From: Anonymous Member
Subject: Clinical investigation Sponsor question

This message was posted by a user wishing to remain anonymous

Hello Regulatory community,

Who is considered the sponsor of a clinical investigation?  My understanding is that it's usually the manufacturer of a device who finances the study.  The manufacturer is ultimately responsible for the conduct of the study and it cannot be outsourced to a third-party (e.g. CRO).  However,  the business department in my company thinks otherwise.  But if we receive clinical investigation authorization from the regulatory agency with our name on it, does this mean we are by default the sponsor?   Can the sponsor ever be a party other than the manufacturer?  Perhaps, the term "sponsor" is more nuanced than I think.

Thanks. I would like to hear your insights.

​The FDA makes the following distinction between a "sponsor" and a "sponsor-investigator"

• "Sponsor" means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor- investigator, and the employees are investigators. (Sec. 312.3 and 812.3)
• "Sponsor-Investigator" means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational device/drug is used. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.(Sec. 312.3 and 812.3)

Based on those definitions, a manufacturer may be considered the "sponsor" of a clinical investigation if takes responsibility and initiate a clinical investigation ( by signing clinical trials agreement with CROs and research institutes and selecting Principal investigators). The manufacturer- as a sponsor- submits a "commercial IND" or "commercial IDE"  if applicable to the FDA.  In this case, the manufacturer has to comply with all "sponsor" obligations, and the "investigators" must comply with all investigator obligations.

Sometimes, an individual, generally a physician, may be considered a sponsor-investigator. For instance, consider an investigator that has an idea than a drug a device or procedure (either approved/ cleared or not ) may be used to mitigate/ cure/ diagnose a condition. The investigator -as an individual sponsor in this case-must submit and "investigator-initiated IND or IDE" to the FDA. If the manufacturer has a current IND / IDE, the investigator contacts the manufacturer to ask for permission to refer the information contained in their existing IND/IDE. In other cases, where there is an invention, the investigator contracts with a GMP/ QSR compliant manufacturer to manufacture the product, if that is the case, the investigator is responsible for the whole content of the IND/ IDE application including the CMC part. If the investigator decides to be the PI of the study , she /he will be responsible for the clinical investigations and will have to comply -in addition to the sponsor obligations- with all investigator obligations.

Hope this helps,

----

Diana Parra, MSc

QA & Reg. Compliance Specialist

MSc Regulatory Affairs

------------------------------
Diana Parra
Pittsburgh PA
United States
------------------------------

Original Message:
Sent: 15-Jul-2019 11:59
From: Anonymous Member
Subject: Clinical investigation Sponsor question

This message was posted by a user wishing to remain anonymous

Hello Regulatory community,

Who is considered the sponsor of a clinical investigation?  My understanding is that it's usually the manufacturer of a device who finances the study.  The manufacturer is ultimately responsible for the conduct of the study and it cannot be outsourced to a third-party (e.g. CRO).  However,  the business department in my company thinks otherwise.  But if we receive clinical investigation authorization from the regulatory agency with our name on it, does this mean we are by default the sponsor?   Can the sponsor ever be a party other than the manufacturer?  Perhaps, the term "sponsor" is more nuanced than I think.

Thanks. I would like to hear your insights.

The sponsor does not have to be a company, it can be an individual (for IIR) or an organization (University).  Here is FDA's definition of a sponsor.

from 21 CFR 312.3

If your company is listed in the IND form where it says Sponsor, then you are the Sponsor.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 15-Jul-2019 11:59
From: Anonymous Member
Subject: Clinical investigation Sponsor question

This message was posted by a user wishing to remain anonymous

Hello Regulatory community,

Who is considered the sponsor of a clinical investigation?  My understanding is that it's usually the manufacturer of a device who finances the study.  The manufacturer is ultimately responsible for the conduct of the study and it cannot be outsourced to a third-party (e.g. CRO).  However,  the business department in my company thinks otherwise.  But if we receive clinical investigation authorization from the regulatory agency with our name on it, does this mean we are by default the sponsor?   Can the sponsor ever be a party other than the manufacturer?  Perhaps, the term "sponsor" is more nuanced than I think.

Thanks. I would like to hear your insights.

Michael, the question was in regards to a device.

------------------------------
Michael Wienholt
Owner & Principal Consultant
Raleigh NC
United States
------------------------------

Original Message:
Sent: 16-Jul-2019 09:48
From: Michael Hamrell
Subject: Clinical investigation Sponsor question

The sponsor does not have to be a company, it can be an individual (for IIR) or an organization (University).  Here is FDA's definition of a sponsor.

from 21 CFR 312.3

Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

If your company is listed in the IND form where it says Sponsor, then you are the Sponsor.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 15-Jul-2019 11:59
From: Anonymous Member
Subject: Clinical investigation Sponsor question

This message was posted by a user wishing to remain anonymous

Hello Regulatory community,

Who is considered the sponsor of a clinical investigation?  My understanding is that it's usually the manufacturer of a device who finances the study.  The manufacturer is ultimately responsible for the conduct of the study and it cannot be outsourced to a third-party (e.g. CRO).  However,  the business department in my company thinks otherwise.  But if we receive clinical investigation authorization from the regulatory agency with our name on it, does this mean we are by default the sponsor?   Can the sponsor ever be a party other than the manufacturer?  Perhaps, the term "sponsor" is more nuanced than I think.

Thanks. I would like to hear your insights.

Sorry.  The same definition is also found in the device regulations.

21 CFR 812.3

If the company is named as the Sponsor in the IDE submission, then you are the 'Sponsor'.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 16-Jul-2019 10:03
From: Michael Wienholt
Subject: Clinical investigation Sponsor question

Michael, the question was in regards to a device.

------------------------------
Michael Wienholt
Owner & Principal Consultant
Raleigh NC
United States

Original Message:
Sent: 16-Jul-2019 09:48
From: Michael Hamrell
Subject: Clinical investigation Sponsor question

The sponsor does not have to be a company, it can be an individual (for IIR) or an organization (University).  Here is FDA's definition of a sponsor.

from 21 CFR 312.3

Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

If your company is listed in the IND form where it says Sponsor, then you are the Sponsor.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 15-Jul-2019 11:59
From: Anonymous Member
Subject: Clinical investigation Sponsor question

This message was posted by a user wishing to remain anonymous

Hello Regulatory community,

Who is considered the sponsor of a clinical investigation?  My understanding is that it's usually the manufacturer of a device who finances the study.  The manufacturer is ultimately responsible for the conduct of the study and it cannot be outsourced to a third-party (e.g. CRO).  However,  the business department in my company thinks otherwise.  But if we receive clinical investigation authorization from the regulatory agency with our name on it, does this mean we are by default the sponsor?   Can the sponsor ever be a party other than the manufacturer?  Perhaps, the term "sponsor" is more nuanced than I think.

Thanks. I would like to hear your insights.

Would be worthwhile to consider also the definition of Sponsor as provided by the ISO14155 Clinical Investigation Of Medical Devices For Human Subjects - Good Clinical Practice recognized in both EU or US:

3.40 sponsor

individual or organization taking responsibility and liability for the initiation or implementation of a clinical investigation

NOTE When an investigator initiates, implements and takes full responsibility for the clinical investigation, the investigator also assumes the role of the sponsor and is identified as the sponsor-investigator.

It is not by default that the Manufacturer of a device will be the Sponsor of the study - it al depends on the roles and responsibilities agreed between parties. The CRO will only take the responsibilities delegated to it officially (i.e. monitoring)

------------------------------
Ioana Ulea
Regulatory Affairs Professional
------------------------------

Original Message:
Sent: 15-Jul-2019 11:59
From: Anonymous Member
Subject: Clinical investigation Sponsor question

This message was posted by a user wishing to remain anonymous

Hello Regulatory community,

Who is considered the sponsor of a clinical investigation?  My understanding is that it's usually the manufacturer of a device who finances the study.  The manufacturer is ultimately responsible for the conduct of the study and it cannot be outsourced to a third-party (e.g. CRO).  However,  the business department in my company thinks otherwise.  But if we receive clinical investigation authorization from the regulatory agency with our name on it, does this mean we are by default the sponsor?   Can the sponsor ever be a party other than the manufacturer?  Perhaps, the term "sponsor" is more nuanced than I think.

Thanks. I would like to hear your insights.​​