Investigator Guidance

Investigator Toolkit

Regulatory Binder/File - The purpose of the Regulatory Binder is to store and organize required and useful study documents and correspondence. The essential documents to each study is maintained in the Regulatory Binder to binder shelfensure efficient management and allow evaluation of the conduct of the study and quality of the data.  


Subject Study Binder - An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual. Below are some sample documents for use as needed.