Fee for Service / OCR Regulatory

Fee For Service Research Cores

The following are fee for service cores that can assist researchers with specific aspects of clinical research work. Typically these may be most useful for sponsor investigators and/or those conducting investigator initiated research work.  

OCR Regulatory  

OCR Regulatory provides subject matter expertise to faculty conducting (i) investigator initiated clinical trials, (ii) non-clinical IND enabling studies, and (iii) manufacturing for use in clinical trials, which make up the key components of a regulatory submission. In addition, the team manages Penn held INDs and IDE’s, trains, and qualifies faculty sponsors, performs IND and IDE exemption determinations, and provides intensive support to faculty translating research from Penn labs into the clinical development. 

  • Provide guidance and templates for the IND/IDE application process; 

  • Assist Penn researchers in fulfilling their regulatory responsibilities as an IND/IDE Sponsor and in preparing for sponsorship; 

  • Ensure appropriate sponsor and institutional oversight of IND/IDE trials in which a Penn faculty member is the regulatory sponsor. 

For an estimate on regulatory services please contact psom-ind-ide@pobox.upenn.edu or call 215-662-4484

Regulatory Support for Investigator Initiated Clinical Trials (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 OCR Regulatory 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.) 

Services

  • 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.
  • To request an IND, IDE, or CTA exemption, please provide the protocol, ICF (if available), and information about the product(s) used (package insert, investigator brochure, device manual, approval documentation, etc) to the OCR Regulatory team at psom-ind-ide@pobox.upenn.edu.

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. 

Samples of Sponsor Related Tools include the following. These are listed in the Forms, Tools, Templates library of this website. Search using words in the names below.

  • 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 

All IND, IDE and CTA Sponsors require 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 OCR Regulatory staff is available to support and provide guidance to faculty who need assistance with regulatory sponsor responsibilities. 

For sponsor training information, see this page.

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 

  • Labeling 

For detailed regulatory requirements, click here 

Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevents of adverse effects or any other medical product-related problem. Sponsors of clinical trials are responsible for pharmacovigilance activities on those trials.  

  • A web-based module on Sponsor Pharmacovigilance Management will be available soon to view on Workday Learning
  • Additionally, OCR Regulatory is available to conduct more trial-specific trainings for those conducting PV activities (PV Leads and Medical Directors / Medical Monitors). Please contact OCR Regulatory at psom-ind-ide@pobox.upenn.edu or 215-662-4484.

Sponsor Qualification, Registration, and Training 

To review the Required Qualifications, Registration, and Training to be a Sponsor or Sponsor-Investigator at the PSOM, please see IND/IDE/CTA Sponsor Training . For more information, contact the Sponsor Support Unit at psom-ind-ide@pobox.upenn.edu or 215-662-4484