Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Request for clarification:
​
Academic Medical Center that serves as Sponsor of record for investigator-initiated trials under IND and IDE. In almost all cases, the Principal Investigator seems to meet the sponsor-investigator definition, as they are initiating, conducting, and responsible for their trials a la, "Sponsor" and "sponsor-investigator" are defined at 21 CFR 312.3(a): "Sponsor means a person who takes responsibility for and initiates a clinical investigation. ... [21 CFR 314 is the section pertaining to requirements for an application for FDA approval to market a new drug, i.e., an NDA.]

For clarification of terms and an explanation, would you please clarify:

1. AMC study where the sponsor of record is the institution for an IND, can there also be a sponsor-investigator (the PI)?  Or can there only be one term for "sponsor?"

2. Is the term sponsor-investigator inappropriate to use as a term for IITs under IND where the PI is acting as a sponsor-investigator in the spirit of the definition?

Thank you.

The Sponsor is the entity named in Box 1 of the Form FDA 1571 and is the entity responsible for maintaining the IND.  Investigators can initiate studies under an IND regardless of the Sponsor - but of course the Sponsor has to agree to file the study to the IND. A Sponsor-Investigator is an individual investigator who files and maintains the IND and is named as the Sponsor on the 1571.  As stated in the Instructions for completing the 1571:

Field 1: NAME OF SPONSOR
The sponsor is the person who takes responsibility for and initiates a clinical investigation. The sponsor may
be an individual, pharmaceutical company, governmental agency, academic institution, private organization
or other organization (21 CFR 312.3(b)). A Sponsor-Investigator is an individual who both initiates and
conducts a clinical investigation and under whose immediate direction the investigational drug is being
administered or dispensed (21 CFR 312.3(b)). For administrative reasons, only one individual should be
designated as sponsor.
If a pharmaceutical company will be supplying the drug, but will not itself be submitting the IND, the
company is not the sponsor.

I would interpret the distinction as follows: an "individual" can Sponsor an IND, but if that "individual" is the investigator who is actually conducting the trial, then s/he is the Sponsor-Investigator.

------------------------------
Glen Park
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 14-Jan-2019 12:05
From: Anonymous Member
Subject: Sponsor-Investigator vs. Principal Investigator

This message was posted by a user wishing to remain anonymous

Request for clarification:
​
Academic Medical Center that serves as Sponsor of record for investigator-initiated trials under IND and IDE. In almost all cases, the Principal Investigator seems to meet the sponsor-investigator definition, as they are initiating, conducting, and responsible for their trials a la, "Sponsor" and "sponsor-investigator" are defined at 21 CFR 312.3(a): "Sponsor means a person who takes responsibility for and initiates a clinical investigation. ... [21 CFR 314 is the section pertaining to requirements for an application for FDA approval to market a new drug, i.e., an NDA.]

For clarification of terms and an explanation, would you please clarify:

1. AMC study where the sponsor of record is the institution for an IND, can there also be a sponsor-investigator (the PI)?  Or can there only be one term for "sponsor?"

2. Is the term sponsor-investigator inappropriate to use as a term for IITs under IND where the PI is acting as a sponsor-investigator in the spirit of the definition?

Thank you.

This message was posted by a user wishing to remain anonymous

​So- if I am understanding this question correctly, you are asking if there can be a sponsor and a sponsor-investigator simultaneously if that individual is the PI while the application holder is an organization? On a 1571 by way of instructions it appears not. That leads me to think that you are asking about other forms of documentation like protocol documents, correspondence, etc.

Who is the IND filer/holder, initiator of the investigation= sponsor "takes responsibility and initiates". This can be an AMC (seen in centralized models) or a PI who staffs an AMC (decentralized model). However, you also mention conducting, which is contained in field 16. Additionally, the instructions for field 1 mention keeping the designation to one individual. I would also consider the responsibilities and requirements of a S-I vs central sponsor: submissions, routine reporting, safety reporting. Is there any action taken on behalf of your investigational application holder, centralized representation for the AMC that submits or intervenes on behalf of the institution, reports and communicates?

IME:
1) Yes, this is an either/or. I have never seen any guidance docs where there is discussion of responsibilities and nomenclature used that support the concept of S-I and sponsor-orgaization at the same time (this can be directly compared to an industry model although the funding source may be different at an AMC).
2) There is one sponsor. The investigator(s) is/are covered in 16/17, responsible for conduct, oversight, review of safety information, progress.
Original Message:
Sent: 14-Jan-2019 12:05
From: Anonymous Member
Subject: Sponsor-Investigator vs. Principal Investigator

This message was posted by a user wishing to remain anonymous

Request for clarification:
​
Academic Medical Center that serves as Sponsor of record for investigator-initiated trials under IND and IDE. In almost all cases, the Principal Investigator seems to meet the sponsor-investigator definition, as they are initiating, conducting, and responsible for their trials a la, "Sponsor" and "sponsor-investigator" are defined at 21 CFR 312.3(a): "Sponsor means a person who takes responsibility for and initiates a clinical investigation. ... [21 CFR 314 is the section pertaining to requirements for an application for FDA approval to market a new drug, i.e., an NDA.]

For clarification of terms and an explanation, would you please clarify:

1. AMC study where the sponsor of record is the institution for an IND, can there also be a sponsor-investigator (the PI)?  Or can there only be one term for "sponsor?"

2. Is the term sponsor-investigator inappropriate to use as a term for IITs under IND where the PI is acting as a sponsor-investigator in the spirit of the definition?

Thank you.

This message was posted by a user wishing to remain anonymous

Thank you​! I think I have reached the level of saturation with responses in my searches that I finally got it. I am a trust and verify to understand why/why not (need rationale to compute) and got it now. Thank you for your time and response.
Original Message:
Sent: 15-Jan-2019 10:41
From: Anonymous Member
Subject: Sponsor-Investigator vs. Principal Investigator

This message was posted by a user wishing to remain anonymous

​So- if I am understanding this question correctly, you are asking if there can be a sponsor and a sponsor-investigator simultaneously if that individual is the PI while the application holder is an organization? On a 1571 by way of instructions it appears not. That leads me to think that you are asking about other forms of documentation like protocol documents, correspondence, etc.

Who is the IND filer/holder, initiator of the investigation= sponsor "takes responsibility and initiates". This can be an AMC (seen in centralized models) or a PI who staffs an AMC (decentralized model). However, you also mention conducting, which is contained in field 16. Additionally, the instructions for field 1 mention keeping the designation to one individual. I would also consider the responsibilities and requirements of a S-I vs central sponsor: submissions, routine reporting, safety reporting. Is there any action taken on behalf of your investigational application holder, centralized representation for the AMC that submits or intervenes on behalf of the institution, reports and communicates?

IME:
1) Yes, this is an either/or. I have never seen any guidance docs where there is discussion of responsibilities and nomenclature used that support the concept of S-I and sponsor-orgaization at the same time (this can be directly compared to an industry model although the funding source may be different at an AMC).
2) There is one sponsor. The investigator(s) is/are covered in 16/17, responsible for conduct, oversight, review of safety information, progress.
Original Message:
Sent: 14-Jan-2019 12:05
From: Anonymous Member
Subject: Sponsor-Investigator vs. Principal Investigator

This message was posted by a user wishing to remain anonymous

Request for clarification:
​
Academic Medical Center that serves as Sponsor of record for investigator-initiated trials under IND and IDE. In almost all cases, the Principal Investigator seems to meet the sponsor-investigator definition, as they are initiating, conducting, and responsible for their trials a la, "Sponsor" and "sponsor-investigator" are defined at 21 CFR 312.3(a): "Sponsor means a person who takes responsibility for and initiates a clinical investigation. ... [21 CFR 314 is the section pertaining to requirements for an application for FDA approval to market a new drug, i.e., an NDA.]

For clarification of terms and an explanation, would you please clarify:

1. AMC study where the sponsor of record is the institution for an IND, can there also be a sponsor-investigator (the PI)?  Or can there only be one term for "sponsor?"

2. Is the term sponsor-investigator inappropriate to use as a term for IITs under IND where the PI is acting as a sponsor-investigator in the spirit of the definition?

Thank you.