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Sly, PhD  \nNCT04450264  \nDocument Date: 1/26/2024  \nIncreasing African Immigrants’ Breast Cancer Screening  \n*  \nProtocol Number : STUDY-19-00114  \nNational Clinical Trial (NCT) Identified Number: NCT04450264 Principal Investigator*: Jamilia R. Sly, PhD Sponsor: Icahn School of Medicine at Mount Sinai Grant Title: Increasing African Immigrants’Breast Cancer Screening Grant Number*: R21MD012863  \nFunded by: National Institute for Minority Health and Health Disparities  \nVersion Number: v. 1.3  \n17 March 2023  \nEffective Date: 1/26/2024  \nEnd Date:1/25/2025  \nCONFIDENTIALITY STATEMENT  \nThis document is confidential communication. Acceptance of this document constitutes agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior approval of the Principal Investigator or other participating study leadership and as consistent with the NIH terms of award.  \n Based on “NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans”  \nEffective Date: 1/26/2024  \nEnd Date:1/25/2025  \nIncreasing African Immigrants’ Breast Cancer Screening Version 1.3  \nProtocol STUDY-19-00114 17 March 2023  \nTable of Contents  \nSTATEMENT OF COMPLIANCE .......................................................................................................................................1  \nINVESTIGATOR’S SIGNATURE ........................................................................................................................................2  \n1 PROTOCOL SUMMARY ......................................................................................................................................3  \n1.1 Synopsis..................................................................................................................................................3  \n1.2 Schema ..................................................................................................................................................4  \n1.3 Schedule of Activities .............................................................................................................................5  \n2 INTRODUCTION.................................................................................................................................................6  \n2.1 Study Rationale ......................................................................................................................................6  \n2.2 Background ............................................................................................................................................7  \n2.3 Risk/Benefit Assessment ........................................................................................................................8  \n2.3.1 Known Potential Risks ........................................................................................................8  \n2.3.2 Known Potential Benefits ...................................................................................................8  \n2.3.3 Assessment of Potential Risks and Benefits .......................................................................8  \n3 OBJECTIVES AND ENDPOINTS ...........................................................................................................................9  \n4 STUDY DESIGN ................................................................................................................................................10  \n4.1 Overall Design ......................................................................................................................................10  \n4.2 Scientific Rationale for Study Design....................................................................................................11  \n4.3 Justification for Intervention...................................................................................","cbCaimQWF5iZ2xxe","https://ap.wps.com/l/cbCaimQWF5iZ2xxe","pdf",701236,44,"English","# STATEMENT OF COMPLIANCE\n## INVESTIGATOR’S SIGNATURE\n# 1 PROTOCOL SUMMARY\n## 1.1 Synopsis\n## 1.2 Schema\n## 1.3 Schedule of Activities\n# 2 INTRODUCTION\n## 2.1 Study Rationale\n## 2.2 Background\n## 2.3 Risk/Benefit Assessment\n# 3 OBJECTIVES AND ENDPOINTS\n# 4 STUDY DESIGN\n## 4.1 Overall Design\n## 4.2 Scientific Rationale for Study Design\n## 4.3 Justification for Intervention\n## 4.4 End-of-Study Definition\n# 5 STUDY POPULATION\n## 5.1 Inclusion Criteria\n## 5.2 Exclusion Criteria\n## 5.3 Lifestyle Considerations\n## 5.4 Screen Failures\n## 5.5 Strategies for Recruitment and Retention\n# 6 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)\n## 6.1 Study Intervention Administration\n## 6.2 Fidelity\n## 6.3 Measures to Minimize Bias: Randomization and Blinding","[{\"question\":\"What trial identifiers and version information are provided for the study?\",\"answer\":\"The protocol lists NCT04450264 and protocol number STUDY-19-00114, with version number v. 1.3. It also provides effective and end dates (1/26/2024 to 1/25/2025).\"},{\"question\":\"What does the confidentiality statement require recipients to do?\",\"answer\":\"It states the document is confidential and that accepting it constitutes agreement not to publish or disclose unpublished information without prior approval from the Principal Investigator or other study leadership, consistent with NIH terms of award.\"},{\"question\":\"Which major protocol sections are included in the Table of Contents?\",\"answer\":\"The document includes compliance and investigator signature, followed by protocol summary (synopsis, schema, schedule), introduction (rationale, background, risk/benefit assessment), objectives and endpoints, study design, study population criteria and recruitment/retention strategies, and study interventions with administration, fidelity, and bias-minimization measures.\"}]","Increasing African Immigrants’ Breast Cancer Screening - Protocol STUDY-19-00114 - Version 1.3 | PDF",1789218832]