chart review protocol template- n u i r b（图审查协议模板- n u i r b）.docVIP

CHART REVIEW PROTOCOL Principal Investigator: Address: IRB Project Title: Site(s) where study will be performed: Protocol Version Date: Introduction - Background and Rationale (include references) Hypothesis/Key Questions (the hypothesis being evaluated; the key questions being asked in the research) Objectives (Primary endpoints of study, listed and numbered individually) Selection of Patients Inclusion Criteria: Exclusion Criteria: Age Range: Note: With regard to research involving pregnant women, prisoners, or minors, the IRB must review the study in accordance with Subparts B, C or D of the federal regulations. If it can be presumed that the subjects are not pregnant, incarcerated, or under the age of 18 during the conduct of the chart review, the Subparts do not apply. If, however, during the course of the chart review, the investigator becomes aware that the subjects meet one or more of these conditions, the PI must either exclude such subjects from the dataset, or the IRB must promptly re-review the proposal in accordance with the requirements of Subparts B, C or D. Indicate if this is a retrospective and/or prospective chart review _____ Retrospective Chart Review (Retrospective means the data is already in existence when the project is submitted to the IRB for initial review. 6.2 _____ Prospective Chart Review (Prospective means the data is not in existence when the project is submitted to the IRB for initial review) 5.3 Provide the date range of the chart review (if this is a retrospective chart review, the end date must come before the IRB submission date): mm/dd/yyyy to mm/dd/yyyy Study Methods Source (location) of records to be reviewed: Describe how the charts to be reviewed will be identified: Describe who will identify charts to be reviewed: Confidentiality of data Describe how data (both paper and electronic) will be stored to safe-guard confidentiality (e.g. in a locked cabinet, password prote