Event Description When did the event occur? Date: Day of the week: Time: Detailed Event Description Including Timeline: Diagnosis: Medications: Autopsy Results: Past Medical/Psychiatric History: Root Cause Analysis - Questions # Analysis Prompts Analysis Root Causal Questions Findings Cause Factors/Root Types Cause Details (Table (Table A-1) A-1) 1 What was the List the relevant process steps as defined by the policy, intended process procedure, protocol, or guidelines in effect at the time flow? of the event. You may need to include multiple processes. Examples of defined process steps may include, but are not limited to: Site verification protocol
Event Description When did the event occur? Date: Day of the week: Time: Detailed Event Description Including Timeline: Diagnosis: Medications: Autopsy Results: Past Medical/Psychiatric History: Root Cause Analysis - Questions # Analysis Questions Prompts Analysis Findings Root Cause Types (Table A-1) Causal Factors/Root Cause Details (Table A-1) 1 What was the intended process flow? List the relevant process steps as defined by the policy, procedure, protocol, or guidelines in effect at the time of the event. You may need to include multiple processes. Examples of defined process steps may include, but are not limited to: Site verification protocol
RCA_framework_10.10.17.docx