September 17, 2007

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 (7200k)

RESEARCH PLAN BY CHAPTER

Preface
Précis pdf (359k)

Part I: Background and Significance

• Chapter 1: Background pdf (183k)
• Chapter 2: Conceptual Design and Framework pdf (105k)
• Chapter 3: Preliminary Studies pdf (770k)
• Chapter 4: Aims and Hypotheses pdf (700k)

Part II: Study Design and Methods

• Chapter 5: Challenges and Approaches pdf (550k)
• Chapter 6: Study Design pdf (393k)
• Chapter 7: Selection of Outcome and Exposure Measures pdf (1110k)
• Chapter 8: Rationale for Outcome Measures pdf (424k)
• Chapter 9: Rationale for Exposure Measures pdf (514k)
• Chapter 10: Statistical Analysis Plan pdf (326k)
• Chapter 11: Data Use and Confidentiality Protections pdf (71k)
• Chapter 12: Human Subjects Protections pdf (158k)

Part III: Study Management and Support

• Chapter 13: Information Management System (IMS) pdf (51k)
• Chapter 14: Adverse Event Reporting and Data Monitoring pdf (374k)
• Chapter 15: Quality Assurance and Quality Control (QA/QC) pdf (153k)
• Chapter 16: Sub-Studies, Outside Additions to the Core Protocol, and Adjunct Studies pdf (38k)
• Chapter 17: The Health Insurance Portability and Accountability Act pdf (30k)
• Chapter 18: References pdf (255k)
• Chapter 19: Revisions, Errata, and Addenda pdf (440k)

APPENDICES

Appendix A: Study Hypotheses

• Appendix A-1: List of Study Hypotheses pdf (774k)

• Appendix A-2: Hypothesis Summaries

• • Pregnancy Outcomes pdf (637k)
  • Neurodevelopment and Behavior pdf (780k)
  • Child Health and Development pdf (962k)
  • Asthma pdf (993k)
  • Obesity and Growth pdf (428k)
  • Injury pdf (518k)
  • Reproductive Development pdf (168k)

Appendix B: Study Locations pdf (221k)

Appendix C: Household Enumeration and Pregnancy Screener Process Flow pdf (33k)

Appendix D: Overview of NCS Data Collection and Corresponding Modalities pdf (103k)

Appendix E: Protocol Review pdf (250k)

Appendix F: Interview and Assessment Overview

• Appendix F-1: Detailed Overview of Questionnaire and Developmental Assessments pdf (310k)
• Appendix F-2: Questionnaire Outlines pdf (215k)

Appendix G: Detailed Overview of Biospecimens pdf (428k)

Appendix H: Detailed Overview of Environmental Measures pdf (1030k)

Appendix I: Detailed Overview of Physical/Clinical Assessments pdf (991k)

Appendix J: List of Methods Development Studies, Reviews/White Papers, Workshops, and Publications from Methods Development Studies and Working Groups pdf (74k)

Appendix K: Statistical Analysis Plan for Birth Defects from Impaired Glucose Mechanisms pdf (347k)