- Document Storage
- Investigational New Drug or Investigational Device Exemption Application Support
- Institutional Review Board Submission
- Additional Regulatory Submissions
- Protocol Development
- Study Feasibility
- Study Placement
- Study Personnel
The CTO offers consultation services regarding study feasibility, protocol development, study start-up, IRB submissions, audits, etc. free of charge.
The CTO assists study teams as they prepare documents for onsite or offsite storage after a study is completed. The actual cost of offsite storage is billed to the project or department.
Investigational New Drug or Investigational Device Exemption Application Support
The CTO guides and supports:
- Investigators who are filing Federal Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications
- Investigators who are serving as a sponsor or investigator for either single- or multi-site projects
- Sponsors or investigators who are completing FDA-mandated submission materials and meeting subsequent reporting and documentation requirements
The office also works with the Stokes leadership personnel on issues of risk and feasibility.
Institutional Review Board Submission
The CTO staff assists investigators who are preparing the following study documents for submission to the Institutional Review Board:
- Initial submission
- Informed consent documents
- Continuing reviews
- Study completion requests
- External/internal serious adverse events
- Safety reports
- Protocol modifications and amendments
- Protocol deviations
- Recruitment materials and advertising
- Consent form translations
Additional Regulatory Submissions
The CTO supports submissions to the following Children's Hospital and University of Pennsylvania organizations:
- Clinical and Translational Research Center
- Radiology Review Committee
- University of Pennsylvania Institutional Review Board
- University of Pennsylvania Radiation Safety Committee
- Children's Hospital departmental committees
- Cardiac Research Review Committee
- Pediatric Protocol Review and Monitoring Committee (Oncology)
- Neonatology Review Committee
- Anesthesiology Review Committee
- Medical Device Committee
The CTO assists investigators with developing protocols that include all aspects necessary for Children's Hospital's standard protocol templates. The protocol templates follow the typical NIH and industry multi-center protocol study formats and are Good Clinical Practices compliant.
The CTO develops recruitment materials and recruitment plans.
The CTO collaborates with investigators and sponsors to determine study feasibility. The staff reviews study protocols with investigators to identify clinical, logistical, and financial issues that may occur during the study. Study coordinators work with investigators and industry sponsors in pre-study site visits to evaluate if operational and enrollment goals are achievable.
The CTO assists industry or other academic centers by identifying potential site investigators at Children's Hospital. An investigator who would like to conduct a clinical trial or has been contacted by industry or another academic center to conduct a clinical trial may contact the CTO for its assistance.
The CTO has a staff of experienced study coordinators, clinical project managers, clinical trial monitors, and clinical research associates. The CTO study personnel can provide a number of services to facilitate the conduct of your study.