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Reporting Sponsor-Investigator IND or IDE

  • Responsible Office: Division of Clinical Research, Research and Innovation
  • Current Approved Version: 08/19/2020
  • Policy Type: Administrative

Policy Statement and Purpose

The purpose of this policy is to outline reporting requirements for VCU sponsors and sponsor-investigators of an Investigational New Drug Application (IND) or an Investigational Device Exemption (IDE). In order for VCU to provide proper oversight and educational resources, the Office of the Vice President for Research and Innovation (OVPRI) must be informed of all IND and IDE activity prior to commencing research. 

Proper adherence to Food and Drug Administration (FDA) regulations is critical to managing risk; noncompliance may result in liability for the individual sponsor or sponsor-investigator and the university. When a faculty member serves as the sponsor of an IND or IDE, the FDA communicates directly with the faculty member, not the university. As such, the reporting requirements for sponsors and sponsor-investigators contained in this policy are critical to ensuring that VCU is aware of all faculty held INDs and IDEs and to assist with compliance with FDA regulations.

This policy does not apply when a pharmaceutical company, governmental agency, academic institution, private organization, or other organization holds the IND or IDE. 

Noncompliance with this policy may result in disciplinary action up to and including termination of employment. VCU supports an environment free from retaliation. Retaliation against any employee who brings forth a good faith concern, asks a clarifying question, or participates in an investigation is prohibited.

Who Should Know This Policy

VCU research employees (including faculty) engaged in investigator-initiated clinical and translational research are responsible for knowing this policy and familiarizing themselves with its contents and provisions.

Definitions

Investigational Device Exemption (IDE)

Prescribed documents/application submitted to the FDA and approved to allow for the conduct of a clinical study using a significant risk device that is new or not approved for that use.

Investigational New Drug Application (IND)

Prescribed documents/application submitted to the FDA and approved to allow for the conduct of a clinical study using a drug that is new or not approved for that dosage, form, or indication.

Investigator

An individual who actually conducts a clinical investigation. See IRB Written Policies and Procedures (WPP) IX-1 – Principal Investigator Eligibility and Statement of Responsibilities for additional information about who can be an investigator.

Nonsignificant Risk Device (NSR IDE)

A medical device that does not meet the definition of a Significant Risk Device.

Significant Risk Device (SR IDE)

From 21 CFR 812.3:

Significant risk device means an investigational device that:

(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;

(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;

(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or

(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Sponsor

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. At VCU a faculty member (not the institution) may be a sponsor.

Sponsor-Investigator (SI)

An individual VCU faculty member (not a company) who both initiates and conducts an investigation and complies with all the obligations of both a sponsor and an investigator.

Contacts

The Office of the Vice President for Research and Innovation officially interprets this policy. The Office of the Vice President for Research and Innovation is responsible for obtaining approval for any revisions as required by the policy Creating and Maintaining Policies and Procedures through the appropriate governance structures. Please direct policy questions to the Division of Clinical Research within the Office of the Vice President for Research and Innovation or to the executive director for clinical research and compliance.

Policy Specifics and Procedures

I. General Requirements

All university employees who serve as a sponsor or plan to file an Investigational New Drug Application (IND) or Significant Risk Investigational Device Exemption (IDE) with the Food and Drug Administration (FDA) must submit all documents relevant to the IND or IDE to the Division of Clinical Research within the OVPRI prior to commencing research. The OVPRI Division of Clinical Research  tracks documentation submitted to and from the FDA via institutional procedures and offers resources for supporting compliance. 

Non-Significant Risk (NSR) IDEs are not submitted to the FDA but do require VCU IRB approval. 

Please note that VCU employees must receive authorization by the vice president for research and innovation as well as approval through the Outside Professional Activity system prior to agreeing to serve as an authorized representative for a pharmaceutical company, governmental agency, academic institution, private organization, or other organization. 

II. Procedures

The following required and recommended procedures support this policy: 

A. Recommended Initial Consultation: 

1. Consultation regarding compliance with this policy is strongly recommended by emailing a request to INDIDE@vcuhealth.org (the central email for the OVPRI Division of Clinical Research, FDA Regulatory Resource Program).

2. Research teams may be referred for consultation by the IRB in the event the IRB determines a proposed study requires an IND or IDE. 

B. Required Training and Education: 

1. All individuals applying to serve as sponsors or sponsor-investigators for VCU clinical research studies under an FDA application must successfully complete VCU-designated training or demonstrate successful completion of alternative training.

2. VCU sponsor-investigator training is developed and managed by the FDA program manager within the OVPRI Division of Clinical Research.

3. On-demand training is offered through Talent@VCU via the “Investigational New Drug Application (IND) Sponsor and Investigator Training Modules” or “Investigational Device Exemptions (IDEs) Sponsor and Investigator Training Modules”

4. Customizable training programs are available by request by emailing indide@vcuhealth.org.

C. Required VCU Documentation: 

The proposed principal investigator is responsible for ensuring that all required VCU forms are completed and submitted as applicable. These include but are not limited to the “Certification of IND/IDE Suitability” and “Plans to Conduct a Clinical Investigation at Multi-Center, External Study Site.”  

D. Required VCU Registration and Reporting:

1. The principal investigator is responsible for submitting all documentation intended for submission to the FDA must first be submitted to the VCU FDA Submission Portal (https://go.vcu.edu/submit/indide) for pre-review.

2. The FDA program manager is responsible for pre-review of all documentation submitted via the VCU FDA Portal and consulting with the sponsor or sponsor-investigator as appropriate or by request.

3. The principal investigator is responsible for ensuring that all subsequent correspondence/submissions to/from the FDA are uploaded to the VCU FDA Submission Portal (https://go.vcu.edu/submit/indide) for institutional recordkeeping in accordance with the following timelines:

i. Within five business days of sending to or receiving from the FDA.

ii. Exception: Any notices of clinical holds shall be submitted within 24 hours of receipt. Serious unanticipated adverse effects shall be submitted concurrent with FDA submission. 

E. Institutional Document Management: 

1. The FDA program manager shall maintain digital copies of the submitted applications, communications, safety reports, amendments, and annual reports on behalf of VCU in the VCU FDA Portal. 

2. The sponsor-investigator maintains the original documentation. 

F. Monitoring:

1. The sponsor-investigator is responsible for ensuring proper monitoring of the investigation(s) per 21 CFR 312.50.

2. VCU FDA Regulatory Resource Program personnel are responsible for providing guidance, best practices, available resources, and consulting with VCU sponsor-investigators in order to ensure compliance with this policy and guide the principal investigator in the FDA submission and review process, together with responsible school or center regulatory personnel

Forms

VCU and FDA forms and templates are located at go.vcu.edu/INDIDE (http://www.research.vcu.edu/IND_IDE/) and referenced in the FDA IND/IDE VCU Submission survey at go.vcu.edu/submit/indide (redcap.vcu.edu/rc/surveys/?s=Xbd3YgHxFe).

1. Certification of IND/IDE Suitability (www.research.vcu.edu/IND_IDE/certification_IND_IDE_suitability.pdf)

2. Plans to Conduct a Clinical Investigation at Multi-Center, External Study Site (This form is required for all VCU faculty held INDs and IDEs that are to be conducted at external VCU sites under this IND or IDE.)

3. Financial Interests Forms for All Clinical Investigators on a VCU Faculty Held IND or IDE (To assist with completing FDA forms 3454 and 3455, these forms are to be collected by the sponsor for all clinical investigators and held by the sponsor for submission to the FDA as needed at the time of a New Drug Application, Premarket Approval or 510K. Note that this does not replace reporting in the AIRS system.)

Related Documents

1. VCU IND/IDE Procedure Handbook

2. 21 CFR 312 – Investigational New Drug Applications (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?cfrpart=312)

3. 21 CFR 812 - Investigational Device Exemptions (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812)

4. 21 CFR 50 - Protection of Human Subjects (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50)

5. 21 CFR 56 - Institutional Review Boards (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56)

6. 21 CFR 54 - Financial Disclosure by Clinical Investigators (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54)

7. 21 CFR 58 – Good Laboratory Practice for Nonclinical Laboratory Studies (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58)

8. 21 CFR 820 - Quality System Regulation (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820)

9. IRB WPP IX-1 – Principal Investigator Eligibility and Statement of Responsibilities

Revision History

This policy supersedes the following archived policies:

Approval/Revision DateTitle
12/03/2015 Reporting Sponsor-Investigator Investigational New Drug Applications (IND) or Investigational Device Exemptions (IDE)
05/16/2018 Reporting Sponsor-Investigator Investigational New Drug Applications (IND) or Investigational Device Exemptions (IDE) [revised definitions of Investigational Device Exemption (IDE) and Investigational New Drug Application (IND)]

FAQ

There are no FAQ associated with this policy and procedure.