Regulatory Support (IND/IDE)
Regulatory Support within the OCR offers support to Penn faculty who:
* Are planning to be or are currently IND/IDE/foreign trial Sponsors,
* Need assistance in determining if a study meets the criteria for IND, IDE, or foreign clinical trial application (CTA) exemption
Activities and Services
Regulatory Support activities include regulatory intelligence and strategy, regulatory operations, liaising with health authorities and others, and regulatory compliance. In addition, the SSU provides education to the general research community, and ensures appropriate oversight of IND/IDE/foreign trials in which a PSOM faculty member or the University is the sponsor.
Examples of Regulatory Services include:
1. IND/IDE/CTA Exemption Determinations for PSOM faculty*
*While we cannot provide exemption determinations for non-PSOM faculty, we can provide guidance to those outside PSOM
2. Assisting with IND/IDE/CTA submissions and meetings with Health Authorities
3. Assisting Sponsors fulfill their regulatory responsibilities
4. Providing Regulatory Sponsor training and education
5. Core document development (e.g., protocol, investigator brochure, DSMB charter, etc.)
In some cases, a human research study using a drug or device product may qualify for an Exemption and not require an IND, IDE, or CTA Application to be filed with the relevant Health Authority. Exempt studies do require IRB oversight regardless of IND/IDE/CTA exemption.
Drug products may include prescription or OTC drugs, biologics, cold isotopes, cosmetics, dietary supplements, and food. To request an IND exemption, please download and complete the Investigational New Drug (IND) and Investigational Device Exemption (IDE) Request Form.
Device products may include but are not limited to machines, implants, in vitro diagnostics/ laboratory developed tests, and device accessories. To request an IDE exemption, please download and complete the Investigational New Drug (IND) and Investigational Device Exemption (IDE) Request Form.
If you plan to conduct a study with a drug or device product in a foreign country, please contact the Sponsor Support Unit at firstname.lastname@example.org or 215-662-4484.
Exemptions by ACC and RRSC
In addition to OCR, an exemption may also be requested from:
The Clinical Trials Scientific Review and Monitoring Committee (CTSRMC) for all cancer trials
The Radioactive Drug Research Committee (RDRC) for any radio isotopes
The Food and Drug Administration (FDA) for all drugs/device products
Assistance with Regulatory Submissions and Meetings with Health Authorities
Regulatory staff is available to help PSOM Faculty prepare for meetings (e.g., pre-submission IND or IDE, Informational, Determination, etc.) with Health Authorities (e.g., FDA, etc.) as well as regulatory submissions.
The OCR provides many useful tools to provide assistance to Penn researchers. These are available here: www.med.upenn.edu/ocr/secure/forms-tools-templates.html
Samples of Sponsor Related Tools include:
- IND Application Template, cover letter, and instructions
- IND Annual Report Template
- IDE Application Template, cover letter, and instructions
- DSMB Charter Template
- Clinical Study Report (CSR) Template
- Vendor Qualification Guide
IND/IDE/CTA Maintenance and Activities
All IND, IDE and CTA Sponsors have study oversight. Sponsors are responsible for ongoing submissions to Health Authorities that include protocol amendments, investigational product manufacturing changes, safety reports, and annual reports. Other responsibilities include periodic progress reports to investigators and other regulatory entities (as applicable). The SSU staff is available to support and provide guidance to faculty who need assistance with regulatory sponsor responsibilities.
Abbreviated IDE Sponsors
Sponsors of abbreviated IDE protocols “are considered to have approved applications for IDE's” per 21 CFR 812.2(b).
Abbreviated IDE Sponsors have regulatory requirements under the following 6 categories:
- Record Keeping
- Prohibition of promotion and other practices
For detailed regulatory requirements, click here
Sponsor Qualification, Registration, and Training
To review the Required Qualifications, Registration, and Training to be a Sponsor or Sponsor-Investigator at the PSOM, please click here. For more information, contact the Sponsor Support Unit at email@example.com or 215-662-4484.
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