VISN 5 MIRECC Research Guide Section Two: Setting Up the Research Study

Research

For MIRECC Staff
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Names to Know
Required Forms

Section Two: Setting Up the Research Study

I.   Documents

A.   Regulatory Documents

Regulatory documents include all IRB, VA R&D and sponsor approval letters and correspondence.

1. Each study must have a regulatory binder or file that contains at least the following:
   
   
   1. Original approved protocol and all revised approved protocols (with HIPAA supplement)
      
      
   2. Original approved consent form and all revised approved consent forms
      
      
   3. Original IRB approval letter
      
      
   4. All communications with the IRB, including annual and final reports
      
      
   5. Original VA R&D approval letter
      
      
   6. All communications with the VA R&D Committee
      
      
   7. All Serious Adverse Event (SAE) documentation
      
      
   8. Original Confidentiality Certificate (if applicable)
      
      
   9. Original FDA Forms (if applicable)
      
      
   10. All communications with sponsor (if applicable)
       
       
   11. VA Research Methods Accountability Form
       
       
   12. VA Clinical Trials Data Sheet
       
       
   13. Copy of Outpatient Clinic Profile
       
       
   14. Investigational Drug Information Record VA Form 10-9012 (if applicable)
       
       
   15. VA Biohazard Form, if data will be analyzed in a VA research laboratory on the 3rd floor
       
       
   16. Proof of completion of required human subject education by key personnel
       
       
   17. Quality Management program (see Section II: Quality Management)
       
       
   18. Standard Operating Procedure for obtaining informed consent (see Section II: Quality Management)
       
       

Helpful Regulatory Documents Hint

• Keep a document in the front of the regulatory binder or file that chronologically lists when amendments or other documents were submitted to the IRB, a description of the submissions, and when they were approved. Update the list when necessary.

B.   Consent Forms

1. Original consent forms should be kept in a locked cabinet, preferably in a room separate from the source documents, with limited staff access.

C.   Source Documents

1. Each study must have a separate source document binder or data file for each participant.
   
   
2. Identify participants only by an assigned subject number in the source document. No documents with identifying information (e.g. name, social security number, telephone number, address, etc) should be kept with the source document.
   
   
3. The source document binder or file should contain documentation that each participant met inclusion/exclusion criteria.
   
   
4. A file linking the participation number with the patient's name should be kept physically separate (preferably in another room), in a locked cabinet, with limited staff access. If this list is on a computer, the file should be password protected, with limited staff access, and the password should be changed every three months.
   
   
   

II.    Quality Management

A.   Quality Management Program

The VA Research Services Office has an approved Quality Management Program. The MIRECC also has a unit specific Quality Management Program, and each laboratory must have their own quality management program and procedures.

B.   Standard Operating Procedure (SOP) for Obtaining Consent

Each laboratory must have an SOP for obtaining human research subject consent.

On to Section Three: Setting Up the Research Study