RT Book, Section A1 Matura, Alice A1 Madrigal, Aurora A2 Kuerer, Henry M. SR Print(0) ID 6412135 T1 Chapter 39. Protocol Components and Production T2 Kuerer's Breast Surgical Oncology YR 2010 FD 2010 PB The McGraw-Hill Companies PP New York, NY SN 978-0-07-160178-8 LK accesssurgery.mhmedical.com/content.aspx?aid=6412135 RD 2024/03/29 AB Protocol development is a meticulous process that requires a team of professionals who are proficient in the performance of the tasks involved. Proper implementation and coordination of the protocol is managed by the research team, which is headed by the principal investigator, who develops the protocol and oversees the overall management of the study. The research nurse or research coordinator is responsible for implementation and coordination of the study according to the protocol requirements. Another important member of the team is a program coordinator, who is knowledgeable about regulatory requirements and ensures that proper documents and updates are submitted to the institutional review board (IRB) in a timely fashion. All members must have a good understanding of the Code of Federal Regulations and International Conference on Harmonisation Guideline for Good Clinical Practice.1