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ACRIN – V1 FORM COMPLETION INSTRUCTIONS PREGNANCY EVALUATION FORM V1 Completion Instructions A V1 Form is required for each participant on study to evaluate childbearing potential. Note: These instructions do not include all questions found on the form Please refer to the general form completion guidelines for further instructions. Contact data management for all form related questions/clarifications. All available dates should be reported as MM-DD-YYYY unless otherwise specified. Code all questions unless otherwise specified; do not leave mandatory questions blank. Please note that online logic requires dates to be no later than current date. 1. Is the participant of childbearing potential? 1 (No) Select reason participant not of childbearing potential in Q1a, then proceed to the end of the form. 2 (Yes) Skip Q1a. Question 2 is required. 2. Was pregnancy test performed? 1 (No) Select reason pregnancy test was NOT performed Q2a, then proceed to the end of the form. 2 (Yes) Skip Q2a. Question 3 is required. 3. Date of pregnancy test: Response required if Q2 reported as Yes. Also report result of pregnancy test in Q3a as: 3a. Result of pregnancy test: 1 (negative) 2 (positive) V1 completion Instructions V1.0 9/16/10 Page 1 of 1