As you create your site’s Standard Operating Procedures (SOPs), it will be helpful to develop
an SOP on regulatory binder/file management that is specific to this question. An SOP on
regulatory binder/file maintenance should address the following:
o Creation/required documents
o Location of various components when study is on-going
o Updating frequency and responsibility
o Management/storage of outdated documents
o Archiving when study is over (including where and for how long records will be stored)
