Regulatory Sciences Office

Support

The Regulatory Sciences Office (RSO) provides expert assistance navigating regulatory requirements for clinical and translational research, including support for:

  • FDA Regulatory Compliance
  • ClinicalTrials.gov Submissions
  • Regulatory Training

Support for FDA Regulatory Compliance

The Regulatory Sciences Office offers services to support clinical and translational research investigators with the navigation of and compliance with specific FDA-regulated processes, including research involving experimental drugs and devices.

  • Investigational New Drugs (IND)
  • Investigational Device Exemptions (IDE)

RSO provides a variety of services to support development of IND application submission and provides guidance and assistance throughout the life cycle of IND-regulated studies.

  • Determination of product classification (i.e., drug, device, combination product, biologic)
  • Applicability of an IND or IDE
  • Assistance with submission of an IND or IDE application
  • Preparation, coordination, facilitation, and attendance at FDA meetings
  • Preparation for and regulatory support during FDA inspections of investigator sponsored clinical trials
  • Update regarding new guidance documents, inspection trends, inspection actions and new regulatory actions taken by FDA relating to clinical trials

ClinicalTrials.gov Submissions

Certain studies are required to be listed on ClinicalTrials.gov. Newer regulations (2007) require all studies that plan to publish outcome information to be registered with ClinicalTrials.gov. RSO can help you determine when your study must be registered, provide registration assistance and notification of requests for updates, and enter results from your data analysis and final report.

Regulatory Training

The Department of Clinical Sciences offers regulatory training. We offer courses in the Responsible Conduct of Clinical Research and Clinical Pharmacology and Drug Development.

Registering in PubMed Central

The NIH Public Access Policy ensures that the public has access to the published results of NIH-funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.  To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.

Because the Center for Translational Medicine is funded by the NIH, investigators who use any of its resources must register in PubMed Central.