In the second year of the MSRA program, students complete two three-month rotation projects at City of hope. The rotation projects will consist of one or a combination of the following:

  • Writing and submission of clinical trial protocol and consent to COH regulatory bodies
  • Preparation of a pre-IND package or parts of an IND, including the Investigator’s Brochure (IB)
  • Review of material/data to be included in the regulatory material and assessment of data requirements and completeness
  • Input in drug development (i.e., participation in team meetings where pre-clinical development is being discussed and evaluated)

Students choose projects from the following rotation departments at City of Hope:

  • Projects may include:

    • Applying regulatory knowledge within the process development process

  • Projects may include:

    • Building a phase 1 clinical protocol from concept

  • Projects may include:

    • Development of a new drug or new drug in practice and/or being optimized once in a clinic
    • Drafting IND and clinical protocol for newly developed drug, or drafting a major CMC amendment to the IND and clinical protocol for the optimized product
    • IND compilation, submission, and FDA review of a new application
    •  

  • Projects may include:

    • Review of annual reports
    • Preparation and review of amendments
    • Monitoring of new FDA, ICH, and other guidance documents relevant to COH projects
    •  

  • Projects may include:

    • Writing clinical trial protocol and consent
    • Submission of protocol and consent to COH regulatory bodies
    • Preparation of a pre-IND package or parts of an IND, including the Investigator’s Brochure (IB)
    • Review of material/data to be included in the regulatory material and assessment of data requirements and completeness
    • Input in drug development, which includes participation in team meetings where preclinical development is being discussed and evaluated
    •