ISMPP Publications Pri mer January 2016 A comprehensive single source overview of medical publications. TM Table of Contents Foreword ...................................................................................................................................... 5 Document Overview ................................................................................................................... 7 Key Terms ..................................................................................................................................... 9 Section 1: Publications 101 ..................................................................................................... 13 1.1 Peer Review............................................................................................................................................................. 13 1.2 Why Write And Submit A Manuscript? .................................................................................................... 14 1.3 Basic Publication Structure ........................................................................................................................... 16 1.4 How to Write Medical Publications ........................................................................................................... 18 1.5 Professional Assistance.................................................................................................................................... 21 1.6 Different Types of Publications ................................................................................................................... 22 Different types of manuscripts................................................................................................................................ 23 Other formats for journal publications ............................................................................................................... 26 Other types of medical publications ..................................................................................................................... 26 1.7 Different Types of Journals ............................................................................................................................ 28 1.8 Reporting Guidelines ......................................................................................................................................... 30 1.9 Submission Requirements.............................................................................................................................. 30 1.10 Reviewer’s Comments and Resubmission............................................................................................. 32 References for Section 1 .................................................................................................................................................. 32 Section 2: Compliance .............................................................................................................. 34 2.1 Comply With What? ............................................................................................................................................ 34 2.2 Why Comply? .......................................................................................................................................................... 34 © 2016 ISMPP 1 ISMPP Publications Pri mer January 2016 2.3 Compliance Guidelines ..................................................................................................................................... 35 International Committee of Medical Journal Editors .................................................................................... 35 Pharmaceutical Research and Manufacturers of America .......................................................................... 36 The European Federation of Pharmaceutical Industries and Associations ........................................ 36 International Society for Medical Publication Professionals ..................................................................... 36 2.4 Special Compliance Issues .............................................................................................................................. 37 2.5 Corporate Integrity Agreements................................................................................................................. 38 2.6 Sunshine Act............................................................................................................................................................ 38 2.7 Anti-Bribery and Corruption Laws ............................................................................................................ 39 2.8 Compliance Examples........................................................................................................................................ 41 2.9 International Compliance Guidance ......................................................................................................... 41 References for Section 2 .................................................................................................................................................. 43 Section 3: Ethics ......................................................................................................................... 45 3.1 Background ............................................................................................................................................................. 45 3.2 Publication Planning.......................................................................................................................................... 46 Publication steering committee.............................................................................................................................. 47 Trial disclosure and publication timing .............................................................................................................. 47 3.3 Publication Development................................................................................................................................ 50 Authorship responsibilities ...................................................................................................................................... 50 Use of a medical writer ............................................................................................................................................... 51 Referencing ...................................................................................................................................................................... 52 Acknowledgments ........................................................................................................................................................ 53 Disclosure ......................................................................................................................................................................... 53 Plagiarism......................................................................................................................................................................... 55 Permissions ..................................................................................................................................................................... 55 Retraction ......................................................................................................................................................................... 56 3.4 Other Legal Requirements For Sponsors And Authors.................................................................. 57 Sunshine Act .................................................................................................................................................................... 57 Anti-Bribery and Corruption laws ......................................................................................................................... 58 Corporate Integrity Agreements ............................................................................................................................ 59 References for Section 3 .................................................................................................................................................. 60 Section 4: Authorship ............................................................................................................... 61 4.1 Which Rules Apply? ............................................................................................................................................ 61 ICMJE authorship criteria .......................................................................................................................................... 61 Different interpretations of ICMJE criteria ........................................................................................................ 62 Acknowledgments ........................................................................................................................................................ 62 Guarantorship................................................................................................................................................................. 63 Transparency .................................................................................................................................................................. 64 Certified Medical Publication Professional