Folder and File Name Descriptions for Electronic Regulatory Binders

Standards:

• For dates of documents, use the version date.
• For dates of sponsor/IRB approval documents, use the approval date, which is either the date of the meeting if reviewed at full board, or the date of the chair signature if expedited review.
• The first level of subfolders are GREEN, followed by the PURPLE (if needed).
• Folders will be listed separately by protocol under each PI.
• All saved documents should be final documents, not draft or working documents

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)

• CR 2011

• Approved documents
• IRB outcome letter: CC number_CR_IRB outcome letter_ decision date [MMDDYY] (this is the date of IRB actual decision) (e.g. 10C0025  CR IRB outcome letter 08-16-16)
• Consent: CC number_amendment letter_CR_ Consent_approval date [MMDDYY] (e.g.10C0025 A CR consent 08-16-16)
• If other consents, use consent name (e.g. Spanish, minor, volunteer, donor, etc): CC number_amendment letter_CR_ minor consent_date [MMDDYY] (e.g. 10C0025 A CR minor consent 08-16-16)
• IRB approval: CC number _CR_IRB approval package_date [MMDDYY] (e.g.10C0025 CR IRB approval package 08-16-16)

CVs

Drug Accountability Records 

• All drug accountability forms will be retained in the CC Pharmacy

• Samples of labels attached to investigational product containers, if applicable
• Shipping records for investigational product and trial-related materials, if applicable
• Drug accountability Record (at study closure)

DSMB/SMC

•   SMC 2011 

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

• • CC number_SMC report date [MMDDYY]

  • CC number_SMC approval date [MMDDYY]

  • CC number_SMC response to stipulations date [MMDDYY]

  • SMC date [MMDDYY]   

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.

• IND report name (use name on file as sent from manufacturer or sponsor) 

Investigator Agreement 

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

Investigator Brochure

• Drug Name IBvX.x_date [MMDDYY] (date=date of version) (i.e. MDX010 IBv6.2 12-10-09)
• IRB receipt IBvX.x_date 

IRB-Approved Documents 

• Initial Approval

• IRB Approval: CC number_ IRB approval memo_date [MMDDYY]

• Protocol: CC number_initial protocol_version date [MMDDYY]

• Consent: CC number_initial consent_IRB approval date [MMDDYY]

• If other consents, use consent name instead of “initial” (e.g. Spanish, minor, volunteer, donor, etc)

• PSU (protocol status update form): CC number_ CTEP#_ initial PSU_date [MMDDYY]

• Final Approval: CC number_final approval package_date [MMDDYY]

• Sponsor approval: Sponsor approval_date [MMDDYY]

• Amendment A

• IRB Approval: CC number A_IRB approval memo_date [MMDDYY]

• CC number A_protocol version_date [MMDDYY]
• CC number A_IRB approval_date [MMDDYY]
• If other consents, use consent name (e.g. Spanish, minor, volunteer, donor, etc—CC number_WM minor consent A_date [MMDDYY]
• CC number_final approval package A_date [MMDDYY]
• Sponsor_approval A_date [MMDDYY]

• Amendment B

• IRB Approval: CC number B_IRB approval B memo_date [MMDDYY]

• CC number B_protocol version_date [MMDDYY]
• CC number B_IRB approval_date [MMDDYY]
• If other consents, use consent name (e.g. Spanish, minor, volunteer, donor, etc—CC number WM minor consent B date [MMDDYY]
• CC number_final approval package B_date [MMDDYY]
• Sponsor approval B date [MMDDYY] 

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 

• CC number_ subject diary_ version date [MMDDYY]
• Short form consent approval [language used_short form_date of approval] e.g. [English short form 02-13-14] 

Monitoring 

• Monitoring Visit Log (provide template)
• Monitoring CVs
• Monitoring Visits 

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

• Date of visit [MM-DD-YY]
• Visit notification_date [MMDDYY]
• Monitor report_date [MMDDYY]
• Site response_date [MMDDYY] 

Multi-Center Documents   

• New folder named for each site  

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

• IRB Approvals

  • Correspondence

  • Initial

    • CC-number (Short name of site) IRB initial approval_date [MMDDYY]

  • Amendments

    • CC number (Short name of site)  amend A approval_date [MMDDYY] 

  • CR Approvals

    • CC number (Short name of site)  CR approval_date [MMDDYY] 

  • Problems

  • Personnel

    • 1572 or Investigator agreement (if not FDA regulated), CV, licenses, Financial Disclosures

  • Lab Normals, CLIA

  • Monitoring

  • Screening and Enrollment Log

  • Site Signature Log/Delegation of Duties

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.  

OSP  

• Initial Submissions

  • CC number_OSP number_application date [MMDDYY] (i.e. GENEX OSP application 01-15-10)

  • CC number_initial protocol version_date [MMDDYY]

  • CC number_IRB approval_date [MMDDYY]

  • OSP approval email_date [MMDDYY] 

• Amendments

  • CC number_OSP number_Amendment letter_approval_date [MMDDYY] (i.e. 10C0052 OSP number A approval 01-15-10)
  • CC number A_protocol version_date [MMDDYY]
  • CC number A_IRB approval_date [MMDDYY]
  • OSP approval email_date [MMDDYY]

• Adverse Events

  • CC number_OSP number_SAE form cover memo_date [MMDDYY] (i.e. 10C0052 OSP number AE form cover memo 1-15-10)

• Annual Reports

  • CC number_OSP number_annual report_date [MMDDYY] (i.e. 10C0052 OSP number annual report 1-15-10)

• Termination

  • CC number_OSP number termination_date [MMDDYY] (i.e. 10C0052 OSP number termination 1-15-10) 

 IBC  

• Initial Submission

  • CC number_IBC number_application_date [MMDDYY] (i.e. GENEX IBC application 01-15-10)

  • CC number_initial protocol version_date [MMDDYY]
  • CC number_IRB approval_date [MMDDYY]
• Amendments
• CC number_IBC number_Amendment letter_approval_date [MMDDYY] (i.e. 10C0052 IBC# A cover memo 01-15-10)
• CC number A_protocol version_date [MMDDYY]
• CC number A_IRB approval_date [MMDDYY]

• Adverse Events

• CC number_IBC number_SAE form_cover memo_date [MMDDYY] (i.e. 10C0052 IBC number AE form cover memo 1-15-10)
•  Annual Reports 
• • • CC number_IBC number__annual report_date [MMDDYY] (i.e. 10C0052 IBC number annual report 1-15-10)

  • Termination

    • CC number_IBC number_termination_date [MMDDYY] (i.e. 10C0052 IBC number termination 1-15-10)  

Patient Recruitment Materials 

Problems

• Serious Adverse Events to Manufacturer or Sponsor 
• CC number_date of event [YYYYMMDD]_name of event (i.e. 13C0013 20111022 pancreatitis)
• •  Problems to IRB
    
    • iris reference number_event name_date of event [MMDDYY]

Publications 

Radiation Safety Committee  

• Initial Application
• CC number_RSC 88-23_application_date [MMDDYY]
• CC number_RSC initial Protocol_date [MMDDYY] (i.e. MDX010Initial protocol 01-15-10)
• CC number_RSC initial Consent_date [MMDDYY] (i.e. MDX010Initial consent 01-15-10
• CC number_RSC initial approval_date
•   Amendment
• CC number_RSC 88-23 application date [MMDDYY]
• CC number_amendment letter_protocol clean_date [MMDDYY] (i.e. 10C0025 B protocol clean 01-15-10)
• CC number_amendment letter_consent clean_date [MMDDYY] (i.e. 10C0025 B consent clean 01-15-10)
• CC number_RSC amendment_approval_date [MMDDYY]
• Triennial Review
• CC number_Triennial review date [MMDDYY]
• CC number_Amendment Letter_Protocol clean_date [MMDDYY] (i.e. 10C0025A protocol clean 01-15-10)
• CC number_Amendment Letter_Consent clean_date [MMDDYY] (i.e. 10C0025A consent clean 01-15-10) 

Sponsor Communication  

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

Study Closure 

• IRB approval memo
• Final Approval package

Study Logs  

• Screening/enrollment log (provide template)
• Subject identification code list
• Delegation of duties/site signature log (provide template)
• Record of retained fluids and samples

Training

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]