Regulatory Affairs provides the following services to clinical investigators in TUSM, LKSOM and other Temple Health Science campus schools.
- Liaison between investigators, study sponsors, and IRBs
- Provides guidance on FDA regulations including IND and IDE submissions
- Development of DSMBs and Data Safety Monitoring Plans
- Assist with the development of Corrective Action Plans (CAPAs) following FDA or sponsor audits
- Group or individual training and education on the regulatory requirements for clinical research
- Provide support to investigators for Clinicaltrials.gov registration and results reporting
- On-site assessments to identify and correct gaps in regulatory compliance
- Provide on-site consultations and training for investigators and research staff on best practices to optimize regulatory compliance
- Guidance on regulatory requirements for investigator-initiated research
- Perform the document review to ensure consistency between the Clinical Trial Agreement (CTA), budget, and Informed Consent Form (ICF)
Contact the Director of Clinical Research Regulatory Affairs, Lisa Landsberg, MEd, CRCP, CHRC at firstname.lastname@example.org or 215-707-7303. Regulatory Affairs is located in Kresge Science Hall East, room 209.
Research involving the off-label use of FDA-regulated products
Investigators whose research will involve the off-label use of FDA-regulated product may require an Investigational New Drug (IND) or Investigational Device Exemption (IDE) prior to beginning their research. Obtaining an IND or IDE involves the submission of an IND/IDE application to the FDA and notification of either exemption or approval by the FDA before the clinical investigation may proceed.
IND: An IND is required in order to use an unapproved FDA-regulated product (such as a drug, botanical or biological) in a clinical investigation. An IND may also be needed to use an FDA approved drug off-label in a clinical investigation unless the criteria for IND exemption are met.
IDE: An IDE allows an investigator to study a significant risk device off-label in a clinical investigation.
Sponsor-Investigators (investigators holding an IND or IDE) must comply with additional FDA reporting requirements under 21CFR312 (IND) and 21CFR812 (IDE).
Contact Lisa Landsberg to discuss your study’s needs.
Clinical trial registration and results reporting on Clinicaltrials.Gov
Clinicaltrials.gov was established in 1997 through the FDA Modernization Act (FDAMA) to provide the public with information about current and completed clinical trials in the US and internationally. Clinical trials that meet the definition of an “applicable clinical trial” under FDAMA, as well as clinical trials that meet other criteria, may be required to register on the web site. Guidelines have been developed for investigators to help them understand the requirements for registering studies and reporting results.
For more information and to obtain a user ID, contact Lisa Landsberg, who serves as Temple’s Clinicaltrials.gov Site Administrator.
Clinical Trial Document Review
The document review is performed to ensure that the information in the Informed Consent Form (ICF) is consistent with the Clinical Trial Agreement (CTA) and study budget, as required by federal regulations. Specifically, the document review focuses on the sections of the ICF that pertain to treatment for subject injury and subject stipends (payment for participation and travel reimbursement). By assuring that the ICF accurately represents the terms of the contract and budget, the subject can make an informed decision about participating in the study.