Risk Stratification for GCRC Protocols

GCRC Protocol #: ______Protocol Title: ______Principal Investigator: ______

A. Identify all applicable study procedures (check all that apply) LEVEL I RISK  Anthropomorphic evaluations  DEXA scans  Electrocardiograms (EKGs)  Exercise testing  Intravenous glucose tolerance tests  Intravenous catheter insertion  Magnetic resonance imaging (MRI) scans  Observational studies  Oral glucose tolerance tests  Pathology slide review  Special/prescribed diets  Venipuncture  Ultrasound/audible vibration  Other low (Level I) risk non-therapeutic tests or studies (list):

LEVEL II RISK  Child population  Approved pharmaceutical agents  Endoscopy/ Bronchoscopy  Arterial catheter insertion  Elderly population  Other vulnerable population  Insulin clamp  Pregnant population  Fat or Muscle biopsy  Psychologically or neurologically impaired population  Research-associated clinical procedures (list):  Other moderate (Level II) risk non-therapeutic tests or studies (list):

LEVEL III- PROTOCOLS REQUIRING DSMB  Gene transfer study  Manufacturing of product on campus  Investigational pharmaceutical agent(s)  Phase I/Phase II protocols with substantial subject risk  Investigational device(s)  Phase III comparative clinical investigation  Investigator-initiated INDS  Research-associated high risk clinical procedures (list):  Other high risk non-therapeutic tests or studies (list):

B. Rank level of risk (select one) LEVEL OF RISK  Level I/Level II Risk Appropriate category if all identified procedures were selected from the Level I risk and/or Level II risk sections above.  Level III Appropriate category if any of the identified procedures were selected from the Level III section.