Regulatory Support | Office of Clinical Research | Perelman School of Medicine at the University of Pennsylvania

Internal Resources

Regulatory Services
Regulatory Support

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.)

IND/IDE/CTA Exemptions

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.

IND 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.

IDE Exemption
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.

CTA Exemption
If you plan to conduct a study with a drug or device product in a foreign country, please contact the Sponsor Support Unit at ind-ide@upenn.edu 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/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:

Oversight
Monitoring/Safety
Record Keeping
Prohibition of promotion and other practices
Reporting
Labelling

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 psom-ind-ide@pobox.upenn.edu or 215-662-4484.