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Human Use Forms

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Some guidance documents and forms are hosted in Sharepoint and require institutional access. Please select the appropriate link for University of Pittsburgh (Pitt) or UPMC users.
 

Guidance

  • General Information -- Pitt | UPMC
  • Requirements for Review -- Pitt | UPMC
  • Flow Chart HUSC Policies -- Pitt | UPMC
  • Informed Consent Statements of Radiation Risk:
    • Whole body (i.e., systemic) radiation exposures (e.g., radioactive drugs): Effective Dose (ED) or Effective Dose Equivalent (EDE) < 1000 mrem -- Pitt | UPMC
    • Whole body (i.e., systemic) radiation exposures (e.g., radioactive drugs): Effective Dose (ED) or Effective Dose Equivalent (EDE) of 1000 mrem - 5000 mrem -- Pitt | UPMC
    • Whole body (i.e., systemic) radiation exposures (e.g., radioactive drugs): Effective Dose (ED) or Effective Dose Equivalent (EDE) of > 5000 mrem (5 rem) -- Pitt | UPMC
    • Single organ radiation exposures (e.g., x-ray procedures) -- Pitt | UPMC

Forms

HUSC FORM 1001:

HUSC FORM 1001 (Pitt | UPMC) should be submitted for all protocols (research and investigational; new and modifications) that utilize external ionizing radiation sources (X-ray/CT/DXA, etc.) and/or radioactive materials.  Without completing this form, your approval may be delayed. 

If you would like to request training on how to complete this form, please contact the RSO.

HUSC FORM 1002:

HUSC FORM 1002 (Pitt | UPMC) is intended to provide a template for the information required by the RDRC to review and approve the use of  a radioactive material in proposed human research applications to be reviewed and approved under 21 CFR 361.1.  This form is waived when the requested radioactive drug is manufactured in accordance with an approved Drug Master File at the University of Pittsburgh PET Facility.  For information regarding the Drug Master File, you may contact James Ruszkiewicz at the PET Facility.

Adverse Reporting:

All Adverse Events (Pitt | UPMC) (regardless of severity) associated with research subject participation in a RDRC approved study must be reported to the RDRC within 24 hours of notification to the PI/study group.

HUSC FORM 1003:

HUSC FORM 1003 is required for any new use of ionizing radiation in a clinical setting. This includes, but is not limited to, replacements of existing equipment, purchase of new equipment, additions of new radiopharmaceuticals, etc.  The form allows for programmatic evaluation and documentation of Radiation Safety Committee approval, which is required by regulation.

If you wish to have a hardcopy of HUSC-RSC Form 1003, a PDF is available here (Pitt | UPMC).

Suggested Reference Materials