vii Regulatory Writing: An Overview
Contents
Chapter 1 An Overview of Medical and Regulatory Writing.......................................................................1
By Danny A. Benau, MSOD, PhD
Chapter 2 Good Documentation Practices. ................................................................................................15
By Jenny Grodberg, PhD, RAC, Jocelyn Jennings, MS, RAC, and Joanne Rupprecht, Esq, RAC
Chapter 3 General Considerations for Quality Regulatory Writing...........................................................23
By E. Mitchell Seymour, PhD, RAC and Gert Bos, MSc, PhD, FRAPS
Chapter 4 Guidance Documents: Beyond the Code of Federal Regulations. .............................................29
By Lisa DeTora, PhD, Jenny Boyar, PhD, Robin Martin, MBA, and Jenny Grodberg, PhD, RAC
Chapter 5 Medical Device Submission Considerations Beyond the US, Canada, and EU.........................41
By Jenny Boyar, PhD and Robin Martin, MBA
Chapter 6 Developing Standard Operating Procedures and Planning and Strategy Documents. ..............45
By Mariam Aslam
Chapter 7 Review and Approval Process.....................................................................................................57
By Jocelyn Jennings, MS, RAC
Chapter 8 Clinical Trial Protocols...............................................................................................................71
By Sharanya Ramasubramanian, MS and Jenny Chen, MD, PhD, RAC
Chapter 9 Informed Consent Form Preparation. ........................................................................................79
By Jenny Grodberg, PhD, RAC
Chapter 10 Data Analysis Plans. ..................................................................................................................89
By Lisa DeTora, PhD
Chapter 11 Clinical Study Reports. ..............................................................................................................99
By Brooke Diorio, John M. Ellison, MS, Helle-Mai Gawrylewski, Anna Mendlin, PhD,
Bertil Wagner, and Kathy Wekselman, PhD, RN
Chapter 12 Integrated CMC Documentation. ...........................................................................................111
By Mariam Aslam
Chapter 13 Integrated Nonclinical Documentation...................................................................................115
By Lisa DeTora, PhD
Contents
Chapter 1 An Overview of Medical and Regulatory Writing.......................................................................1
By Danny A. Benau, MSOD, PhD
Chapter 2 Good Documentation Practices. ................................................................................................15
By Jenny Grodberg, PhD, RAC, Jocelyn Jennings, MS, RAC, and Joanne Rupprecht, Esq, RAC
Chapter 3 General Considerations for Quality Regulatory Writing...........................................................23
By E. Mitchell Seymour, PhD, RAC and Gert Bos, MSc, PhD, FRAPS
Chapter 4 Guidance Documents: Beyond the Code of Federal Regulations. .............................................29
By Lisa DeTora, PhD, Jenny Boyar, PhD, Robin Martin, MBA, and Jenny Grodberg, PhD, RAC
Chapter 5 Medical Device Submission Considerations Beyond the US, Canada, and EU.........................41
By Jenny Boyar, PhD and Robin Martin, MBA
Chapter 6 Developing Standard Operating Procedures and Planning and Strategy Documents. ..............45
By Mariam Aslam
Chapter 7 Review and Approval Process.....................................................................................................57
By Jocelyn Jennings, MS, RAC
Chapter 8 Clinical Trial Protocols...............................................................................................................71
By Sharanya Ramasubramanian, MS and Jenny Chen, MD, PhD, RAC
Chapter 9 Informed Consent Form Preparation. ........................................................................................79
By Jenny Grodberg, PhD, RAC
Chapter 10 Data Analysis Plans. ..................................................................................................................89
By Lisa DeTora, PhD
Chapter 11 Clinical Study Reports. ..............................................................................................................99
By Brooke Diorio, John M. Ellison, MS, Helle-Mai Gawrylewski, Anna Mendlin, PhD,
Bertil Wagner, and Kathy Wekselman, PhD, RN
Chapter 12 Integrated CMC Documentation. ...........................................................................................111
By Mariam Aslam
Chapter 13 Integrated Nonclinical Documentation...................................................................................115
By Lisa DeTora, PhD