TY  - CHAP
M1  - Book, Section
TI  - Chapter 39. Protocol Components and Production
A1  - Matura, Alice
A1  - Madrigal, Aurora
A2  - Kuerer, Henry M.
PY  - 2010
T2  - Kuerer's Breast Surgical Oncology
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  
SN  - 
PB  - The McGraw-Hill Companies
CY  - New York, NY
Y2  - 2024/04/19
UR  - accesssurgery.mhmedical.com/content.aspx?aid=6412135
ER  -