MIRECC / CoE
VISN 5 MIRECC - Research Guide Section Two: Setting Up the Research Study
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Conducting Research Guide
Section One: New Protocol Approval for MIRECC Studies
Section One: New Protocol Approval for Non-MIRECC Mental Health Studies
Required Forms
Required Training
Staff Directory
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:
a. Original approved protocol and all revised approved protocols (with HIPAA supplement)
b. Original approved consent form and all revised approved consent forms
c. Original IRB approval letter
d. All communications with the IRB, including annual and final reports
e. Original VA R&D approval letter
f. All communications with the VA R&D Committee
g. All Serious Adverse Event (SAE) documentation
h. Original Confidentiality Certificate (if applicable)
i. Original FDA Forms (if applicable)
j. All communications with sponsor (if applicable)
k. VA Research Methods Accountability Form
l. VA Clinical Trials Data Sheet
m. Copy of Outpatient Clinic Profile
n. Investigational Drug Information Record VA Form 10-9012 (if applicable)
o. VA Biohazard Form, if data will be analyzed in a VA research laboratory on the 3rd floor
p. Proof of completion of required human subject education by key personnel
q. Quality Management Program (see Section II: Quality Management)
r. Standard Operating Procedure for obtaining informed consent (see Section II: Quality Management)
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.
III. Audits
Audits of MIRECC protocols are performed by a member of the Research Core. Every MIRECC study will be audited at least once during the life of the study, according to the protocol set forth in the MIRECC Unit Specific Quality Management Program, (Section IV. D. - Audit Process). During the audit, VA participant files, chosen at random, as well as regulatory documents and required staff training documentation will be reviewed. The auditors and the principal investigators whose protocols are scheduled to be reviewed will be so informed a few weeks in advance in order to have the opportunity to agree upon a convenient date for the audit.
