Folder and File Name Descriptions for Electronic Regulatory Binders

Regulatory File

  It is recommended to put folders in alphabetical order.

Continuing Reviews

   Each year of the CR should have its own subfolder: CR 2010, CR 2011, and so forth

(if twice yearly, include month)

Drug Accountability Records 

Create a new folder for each year's submission to the SMC or DSMB

IND Safety Reports (use if receiving reports from a Sponsor or manufacturer)

Save all IND safety reports as a pdf.  First save the email as a pdf, and merge it with the pdf of the safety report so that it is one document.

Investigator Agreement 

1572 (if FDA regulated) or Investigator agreement (if not FDA regulated).

Investigator Brochure
IRB-Approved Documents 
IRB Membership and FWA
 Lab Normals and Certifications 

Save Lab normals and certifications here from NIH and outside labs used by patients.  

Miscellaneous IRB Submissions 

Create a new folder for each monitoring visit. In the subfolders, you would save the relevant final documents as listed below.  

Multi-Center Documents   

Within each folder, you would set up subfolder similar to what is set up for the protocol at this site. 

Notes to File 

The purpose of this file is to document unusual events that occur during the couse of a clinical trial. 

If applicable, include a Note to File referencing where the CV, licenses and IRB membership roster, can be located.  

Patient Recruitment Materials 


Radiation Safety Committee  
Sponsor Communication  

Only include correspondence that is not directly related to an IRB action (if related, please file with that action). 

Study Closure 

Study Logs  

Maintain all HSP, GCP and PI training certificates here.  Also save records of any nursing in-service or other protocol-specific training. 

[Last name of person trained date of training]