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Services


Consultation

The CRSO offers consultation services regarding study feasibility, protocol development, study start-up, IRB submissions, audits, etc. free of charge.


Document Storage

The CRSO 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 CRSO 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 CRSO 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 CRSO supports submissions to the following Children's Hospital and University of Pennsylvania organizations:


Protocol Development

The CRSO 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.


Recruitment

The CRSO develops recruitment materials and recruitment plans.


Study Feasibility

The CRSO 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.


Study Placement

The CRSO 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 CRSO for its assistance.


Study Personnel

The CRSO has a staff of experienced study coordinators, clinical project managers, clinical trial monitors, and clinical research associates. The CRSO study personnel can provide a number of services to facilitate the conduct of your study.