National Children’s Study Research Plan 

The National Children’s Study Research Plan may be downloaded in its entirety or by chapter.

Comments and communication about the Research Plan may be submitted by e-mail to: ncsinfo@mail.nih.gov

RESEARCH PLAN (PDF 7.21 MB)

RESEARCH PLAN BY CHAPTER

Preface (PDF 24 KB)
Précis (PDF 358 KB)

Part I: Background and Significance

• Chapter 1: Background (PDF 183 KB)
• Chapter 2: Conceptual Design and Framework (PDF 105 KB)
• Chapter 3: Preliminary Studies (PDF 77 KB)
• Chapter 4: Aims and Hypotheses (PDF 69 KB)

Part II: Study Design and Methods

• Chapter 5: Challenges and Approaches (PDF 55 KB)
• Chapter 6: Study Design (PDF 393 KB)
• Chapter 7: Selection of Outcome and Exposure Measures (PDF 155 KB)
• Chapter 8: Rationale for Outcome Measures (PDF 425 KB)
• Chapter 9: Rationale for Exposure Measures (PDF 515 KB)
• Chapter 10: Statistical Analysis Plan (PDF 326 KB)
• Chapter 11: Data Use and Confidentiality Protections (PDF 71 KB)
• Chapter 12: Human Subjects Protections (PDF 158 KB)

Part III: Study Management and Support

• Chapter 13: Information Management System (IMS) (PDF 51 KB)
• Chapter 14: Adverse Event Reporting and Data Monitoring (PDF 37 KB)
• Chapter 15: Quality Assurance and Quality Control (QA/QC) (PDF 154 KB)
• Chapter 16: Sub-Studies, Outside Additions to the Core Protocol, and Adjunct Studies (PDF 38 KB)
• Chapter 17: The Health Insurance Portability and Accountability Act (PDF 30 KB)
• Chapter 18: References (PDF 258 KB)
• Chapter 19: Revisions, Errata, and Addenda (PDF 44 KB)

APPENDICES

Appendix A: Study Hypotheses

• Appendix A-1: List of Study Hypotheses (PDF 45 KB)
• Appendix A-2: Hypothesis Summaries
• Pregnancy Outcomes (PDF 456 KB)
• Neurodevelopment and Behavior (PDF 591 KB)
• Child Health and Development (PDF 667 kb)
• Asthma (PDF 660 KB)
• Obesity and Growth (PDF 343 KB)
• Injury (PDF 370 KB)
• Reproductive Development (PDF 164 KB)

Appendix B: Study Locations (PDF 868 KB)

Appendix C: Household Enumeration and Pregnancy Screener Process Flow (PDF 45 KB)

Appendix D: Overview of NCS Data Collection and Corresponding Modalities (PDF 99 KB)

Appendix E: Protocol Review (PDF 109 KB)

Appendix F: Interview and Assessment Overview

• Appendix F-1: Detailed Overview of Questionnaire and Developmental Assessments (PDF 1.01 MB)
• Appendix F-2: Questionnaire Outlines (PDF 203 KB)

Appendix G: Detailed Overview of Biospecimens (PDF 379 KB)

Appendix H: Detailed Overview of Environmental Measures (PDF 248 KB)

Appendix I: Detailed Overview of Physical/Clinical Assessments (PDF 148 KB)

Appendix J: List of Methods Development Studies, Reviews/White Papers, Workshops, and Publications from Methods Development Studies and Working Groups (PDF 70 KB)

Appendix K: Statistical Analysis Plan for Birth Defects from Impaired Glucose Mechanisms (PDF 321 KB)