--------------- -------------------------------------------------------------------
  **(For          
  facilities who  
  use an          
  affiliate IRB   
  and, therefore, 
  will be         
  reviewed by     
  NCQA using only 
  the INR         
  standards.)**   

                  

                  

                  

                  
  --------------- -------------------------------------------------------------------

![](media/image1.png){width="1.16875in" height="0.5986111111111111in"}

  ------------------ -------- ------------- -------- --------------- -------
  Institutional                                                      
  Responsibilities                                                   
  (INR): Elements                                                    
  and points by data                                                 
  sources                                                            

  Documented Process          Reports                Records/files   

  INR 1A             0.8      INR 1D        2.0      INR 4B          2.0

  INR 1B             0        INR 1E        2.0      INR 4C          2.0

  INR 1C             0.8      INR 2A        2.0                      

  INR 2B             0.8      INR 2C        2.0                      

  INR 3A             0.8      INR 5A        2.0                      

  INR 3B             0.8      INR 6B        2.0                      

  INR 4A             0.8                                             

  INR 4D             0                                               

  INR 6A             0.8                                             

  INR 6C             0.8                                             

  INR 6D             0.8                                             

                     7.2                    12.0                     4.0
  ------------------ -------- ------------- -------- --------------- -------

#### 

#### Definitions: 

Data sources- types of documentation or evidence that NCQA reviews in
assessing compliance with an element. There are four types of data
sources and note that these are specified in the individual elements.

Documented processes- Written statements describing procedures. *These
must be local and specific to the individual VAMC.* They may include
standard operating procedures (SOPs), policies and procedures, process
flow charts, contracts, bylaws, execution plans for quality assurance,
instruction manuals and template forms or other mechanisms that describe
an actual process used by the individual VAMC.

Reports- Aggregated sources showing evidence of action (performance of
the HRPP). These may include meeting minutes, management reports,
quality assurance reports, and survey results. Note: an audit from
outside the VAMC (e.g., by the FDA) does not constitute a report UNLESS
there is a detailed response to the audit by the VAMC.

Records or files- Actual protocol files (including associated minutes
and consent forms), records of training, log books, pharmacy dispensing
logs or other documentation that show direct action by the VAMC
(including for some elements, receipt of information).

Materials- Any prepared material or content that the organization
provides to its IRB members, investigators, employees, patients,
research subjects or the public, including written communication, radio
spots or video clips, web site postings, scripts, subject instructions,
brochures or advertisements.

Note:

-   You cannot substitute data sources. If the element calls for a
    documented process, the source must be a documented process, not a
    report.

-   INR 1A is a must pass element.

  -----------------------------------------------------------------------
  **DIRECTIONS: Please mark "Y" for Yes, "N" for No, or "N/A" for not
  applicable to evaluate your institution's human research protection
  program's written statements describing the following procedures.**

  -----------------------------------------------------------------------

<table>
<colgroup>
<col style="width: 39%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 14%" />
<col style="width: 0%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 5%" />
<col style="width: 31%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="8"><strong>Element INR 1A (page 1) * MUST PASS ELEMENT
*</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">The institution ensures its compliance with VA and
Federal regulations concerning the protection of human research subjects
by:</td>
<td rowspan="8"></td>
</tr>
<tr class="odd">
<td colspan="8"><ol type="1">
<li><p>Maintaining a written assurance</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="2" type="1">
<li><p>Identifying the official who is responsible for the
assurance</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="3" type="1">
<li><p>Documenting principles concerning the protection of human
research subjects</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="4" type="1">
<li><p>Documenting the organizational structure, process, roles and
responsibilities for making policy to protect human research
subjects</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="5" type="1">
<li><p>Having an arrangement for an IRB registered with OHRP.</p></li>
</ol></td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="4" rowspan="2"><p><strong>Scoring rules:</strong> 5 factors
= 100%; Factors 1 &amp; 2 + 2 others = 75%; Factors 1 &amp; 2 plus</p>
<p>1 other = 50%; else 0%</p></td>
<td colspan="4">Possible points</td>
<td>0.8</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="4">Points earned</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="8"><strong>Element INR 1B (page 3)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="odd">
<td colspan="11">A designated committee or individual (e.g., R&amp;D
Committee, ACOS for R&amp;D or R&amp;D Coordinator) ensures that the
human research protection program (HRPP) is
operational<strong>.</strong> The following specific responsibilities
must be documented and assigned:</td>
<td rowspan="7"></td>
</tr>
<tr class="even">
<td colspan="8"><ol type="1">
<li><p>Implementation of the institution's HRPP policy</p></li>
</ol></td>
<td><strong> </strong></td>
<td><strong> </strong></td>
<td><strong> </strong></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="2" type="1">
<li><p>Review and evaluation of the reports and results of compliance
assessment and quality improvement activities (QA/QI) related to
research</p></li>
</ol></td>
<td><strong> </strong></td>
<td><strong> </strong></td>
<td><strong> </strong></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="3" type="1">
<li><p>Implementation of needed improvements and follow-up on actions,
as appropriate</p></li>
</ol></td>
<td><strong> </strong></td>
<td><strong> </strong></td>
<td><strong> </strong></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="4" type="1">
<li><p>Monitoring changes in VA and other Federal regulations and
policies that relate to human research protections.</p></li>
</ol></td>
<td><strong> </strong></td>
<td><strong> </strong></td>
<td><strong> </strong></td>
</tr>
<tr class="even">
<td colspan="4" rowspan="2"><p><strong>Scoring rules:</strong> 4 factors
= 100%;</p>
<p>3 factors = 75%; 2 factors = 50%; else 0%</p></td>
<td colspan="4">Possible points</td>
<td>0</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="4">Points earned</td>
<td>0</td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="7"><strong>Element INR 1C (page 4)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="odd">
<td colspan="11">The institution has a documented process for responding
to research-related complaints and allegations of noncompliance with
institutional policies related to the HRPP that:</td>
<td rowspan="8"></td>
</tr>
<tr class="even">
<td colspan="7"><ol type="1">
<li><p>Ensures a response to each complaint or allegation</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"><ol start="2" type="1">
<li><p>Requires investigation of complaints and allegations</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="3" type="1">
<li><p>Establishes remedial action for and consequences of findings of
noncompliance with HRPP and IRB policies</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"><ol start="4" type="1">
<li><p>Includes a process for reporting to institutional officials and
other appropriate parties and authorities</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="5" type="1">
<li><p>Has been in place for at least 12 months.</p></li>
</ol></td>
<td colspan="2"> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="6" rowspan="2"><p><strong>Scoring rules:</strong> 5 factors
= 100%;</p>
<p>4 factors = 75%; 3 factors = 50%; else 0%</p></td>
<td>Possible points</td>
<td colspan="2">0.8</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Points earned</td>
<td colspan="2"> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="7"><strong>Element INR 1D (page 5)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">The institution engages in a systematic budgeting
process for the HRPP. When developing or evaluating the HRPP budget, the
institution considers the following factors:</td>
<td rowspan="7"> </td>
</tr>
<tr class="odd">
<td colspan="7"><ol type="1">
<li><p>Personnel</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="2" type="1">
<li><p>Materials and supplies</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"><ol start="3" type="1">
<li><p>Space</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="4" type="1">
<li><p>Capital equipment</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"><ol start="5" type="1">
<li><p>Training and education.</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"><p><strong>Scoring rules</strong>: 4-5 factors =
100%;</p>
<p>3 factors = 75%; 2 factors = 50%; else 0%</p></td>
<td colspan="5">Possible points</td>
<td colspan="2">2.0</td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="7"><strong>Element INR 1E (page 6)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">The institution has accurate and complete records that
indicate the following for each active research protocol:</td>
<td rowspan="7"> </td>
</tr>
<tr class="odd">
<td colspan="7"><ol type="1">
<li><p>Date of original IRB approval</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="2" type="1">
<li><p>Date of original R&amp;D committee approval</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"><ol start="3" type="1">
<li><p>Date of most recent IRB approval</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="4" type="1">
<li><p>Date by which next IRB continuing review must occur.</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="5" rowspan="2"><p><strong>Scoring rules</strong>: 4 factors
= 100%;</p>
<p>3 factors = 75%; 2 factors = 50%; else 0%</p></td>
<td colspan="2">Possible points</td>
<td colspan="2">2.0</td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="2">Points earned</td>
<td colspan="2"> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="8"><strong>Element INR 2A (page 7)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">Prior to selection/designation of an external IRB, the
institution evaluates the IRB's capacity to perform the designated
activities.</td>
<td rowspan="3"> </td>
</tr>
<tr class="odd">
<td colspan="3" rowspan="2"><strong>Scoring rules</strong>: The
institution evaluated the IRB's capacity = 100%; else 0%</td>
<td colspan="5">Possible points</td>
<td>2.0</td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="5">Points earned</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="8"><strong>Element INR 2B (page 9)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">If the institution uses a VAMC multi-site IRB or the
IRB(s) of an affiliated university or another VA facility, there is a
formal IRB agreement that includes, at a minimum:</td>
<td rowspan="9"> </td>
</tr>
<tr class="odd">
<td colspan="8"><ol type="1">
<li><p>Specific requirements for the membership and operation of the IRB
to review VA research, in compliance with VA regulations</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="2" type="1">
<li><p>The respective responsibilities for human subject protection of
each institution and of the designated IRB</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="3" type="1">
<li><p>The scope of VA activities to be reviewed by the IRB</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="4" type="1">
<li><p>The method, frequency and nature of reporting to the R&amp;D
committee</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="5" type="1">
<li><p>The process by which the institution evaluates the IRB's
performance</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="6" type="1">
<li><p>The remedies available to the institution, including revocation
of the formal IRB agreement, if the designated IRB does not fulfill its
obligations.</p></li>
</ol></td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="4" rowspan="2"><p><strong>Scoring rules</strong>: 5-6
factors = 100%;</p>
<p>4 factors = 75%; 3 factors = 50%; else 0%</p></td>
<td colspan="4">Possible points</td>
<td>0.8</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="4">Points earned</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="8"><strong>Element INR 2C (page 11)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">The institution oversees its designated IRB(s) and
documents consideration of the following:</td>
<td rowspan="7"></td>
</tr>
<tr class="odd">
<td colspan="8"><ol type="1">
<li><p>For new IRB chairs (appointed within the look-back period), the
institution assess the qualifications and experience of the IRB
Chair</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="2" type="1">
<li><p>That the IRB and the membership of the IRB are appropriate, given
the research being reviewed</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="3" type="1">
<li><p>That the IRB includes representatives, either as members or ad
hoc consultants, interested in or who have experience with vulnerable
populations involved in research</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="4" type="1">
<li><p>Adequacy of the IRB's policies and procedures.</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="3" rowspan="2"><p><strong>Scoring rules</strong>:
Documentation of all factors = 100%; documentation of all but 1 factors
= 75%; documentation of all but 2 factors = 50%;</p>
<p>else 0%</p></td>
<td colspan="5">Possible points</td>
<td>2.0</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="5">Points earned</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="8"><strong>Element INR 3A (page 12)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong> Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">The institution has a documented process to identify
and manage conflict of interest of IRB members that:</td>
<td rowspan="8"><p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p></td>
</tr>
<tr class="odd">
<td colspan="8"><ol type="1">
<li><p>Defines conflict of interest</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="2" type="1">
<li><p>Establishes rules for IRB-member declaration of
conflicts</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="3" type="1">
<li><p>Establishes processes for evaluating any conflict of
interest</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="4" type="1">
<li><p>Outlines preferred or allowable remedies to manage the conflict
or eliminate the conflicting interest</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="5" type="1">
<li><p>Has been in place for at least 12 months.</p></li>
</ol></td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="4" rowspan="2"><p><strong>Scoring rules</strong>: 5 factors
= 100%;</p>
<p>4 factors = 75%; 3 factors = 50%; else 0%</p></td>
<td colspan="4">Possible points</td>
<td>0.8</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="4">Points earned</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="8"><strong>Element INR 3B (page 13)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong> Source/ Comments</strong></td>
</tr>
<tr class="odd">
<td colspan="11">The institution has a documented process for
identification and management of conflicts of interest for
investigators.</td>
<td rowspan="3"> </td>
</tr>
<tr class="even">
<td rowspan="2"><p><strong>Scoring rules</strong>: complete = 100%;</p>
<p>not complete = 0%</p></td>
<td colspan="7">Possible points</td>
<td>0.8</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7">Points earned</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="8"><strong>Element INR 4A (page 14)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="odd">
<td colspan="11">The institution has a documented process for handling
investigational drugs, as required by Federal regulations, that
addresses the following:</td>
<td rowspan="8"><p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p></td>
</tr>
<tr class="even">
<td colspan="8"><ol type="1">
<li><p>Receipt</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="2" type="1">
<li><p>Storage</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="3" type="1">
<li><p>Security</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="4" type="1">
<li><p>Dispensing</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="5" type="1">
<li><p>Disposition of unused stock.</p></li>
</ol></td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="6" rowspan="2"><p><strong>Scoring rules</strong>: 5 factors
= 100%;</p>
<p>4 factors = 75%; 3 factors = 50%; else 0%</p></td>
<td colspan="2">Possible points</td>
<td>0.8</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Points earned</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="8"><strong>Element INR 4B (page 16)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">The Pharmacy Service maintains an investigational drug
log, which includes all information required by Federal regulation and
policy: (See also the ACE! Pharmacy Tool for greater explanation of the
factors.)</td>
<td rowspan="15"><p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p></td>
</tr>
<tr class="odd">
<td colspan="8"><ol type="1">
<li><p>Name of drug</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="2" type="1">
<li><p>Manufacturer or other source</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="3" type="1">
<li><p>Date of receipt of the drug</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="4" type="1">
<li><p>Quantity received</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="5" type="1">
<li><p>Expiration date</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="6" type="1">
<li><p>Control number</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="7" type="1">
<li><p>Date protocol approved</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="8" type="1">
<li><p>Name of authorized practitioner signing the prescription</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="9" type="1">
<li><p>Name of the patient receiving the prescription</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="10" type="1">
<li><p>Serial number of the prescription</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="11" type="1">
<li><p>Quantity dispensed</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="12" type="1">
<li><p>Balance remaining after the transaction.</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="6" rowspan="2"><strong>Scoring rules</strong>: In 3 active
drug studies, the investigational log contains ALL 12 factors= 100%; In
2 active drug studies, the investigational log contains ALL 12 factors =
50%; else 0%; NA if the institution does not conduct investigational
drug research or none in past year.</td>
<td colspan="2">Possible points</td>
<td>2.0</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Points earned</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td colspan="8"><strong>Element INR 4C (page 18)</strong></td>
<td><strong>Y</strong></td>
<td><strong>N</strong></td>
<td><strong>N/A</strong></td>
<td><strong> Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="11">The Pharmacy Service ensures that investigational drugs
are not dispensed without the following on file in the pharmacy:</td>
<td rowspan="6"><p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p></td>
</tr>
<tr class="odd">
<td colspan="8"><ol type="1">
<li><p>Approved protocol</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="2" type="1">
<li><p>Signed informed consent form</p></li>
</ol></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="3" type="1">
<li><p>VA Form 10-9012 (Investigational Drug Information
Record)..</p></li>
</ol></td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td colspan="6" rowspan="2"><strong>Scoring rules</strong>: In 3 active
drug studies, files contain ALL 3 factors = 100%; In 3 active drug
studies, files are missing at least 1 factor = 0%; NA if the institution
does not conduct investigational drug research or none in past
year.</td>
<td colspan="2">Possible points</td>
<td>0</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2">Points earned</td>
<td>0</td>
<td> </td>
<td> </td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 37%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 12%" />
<col style="width: 2%" />
<col style="width: 2%" />
<col style="width: 2%" />
<col style="width: 4%" />
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 31%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="8"><strong>Element INR 4D (page 19)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td><strong>N</strong></td>
<td colspan="2"><strong>N/A</strong></td>
<td><strong> Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="13">The institution has a documented process for the use of
investigational devices that addresses the following:</td>
<td rowspan="6"><p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p></td>
</tr>
<tr class="odd">
<td colspan="8"><ol type="1">
<li><p>Storage</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="2" type="1">
<li><p>Security</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="3" type="1">
<li><p>Dispensing.</p></li>
</ol></td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
</tr>
<tr class="even">
<td colspan="6" rowspan="2"><p><strong>Scoring rules</strong>: 3 factors
= 100%;</p>
<p>2 factors = 50%; else 0%</p></td>
<td colspan="2">Possible points</td>
<td colspan="2">0</td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Points earned</td>
<td colspan="2">0</td>
<td> </td>
<td colspan="2"> </td>
</tr>
<tr class="even">
<td colspan="8"><strong>Element INR 5A (page 20)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td><strong>N</strong></td>
<td colspan="2"><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="odd">
<td colspan="13"><ol type="1">
<li><p>The institution annually evaluates investigator compliance with
HRPP and IRB requirements.</p></li>
</ol></td>
<td rowspan="3"></td>
</tr>
<tr class="even">
<td colspan="2" rowspan="2"><strong>Scoring rules</strong>: Institution
evaluates investigator compliance = 100%; else 0%</td>
<td colspan="6">Possible points</td>
<td colspan="2">2.0</td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="6">Points earned</td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
</tr>
<tr class="even">
<td colspan="8"><strong>Element INR 6A (page 22)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td><strong>N</strong></td>
<td colspan="2"><strong>N/A</strong></td>
<td><strong> Source/ Comments</strong></td>
</tr>
<tr class="odd">
<td colspan="13">The institution sets requirements for education and
training, including:</td>
<td rowspan="6"><p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p></td>
</tr>
<tr class="even">
<td colspan="8"><ol type="1">
<li><p>Type and scope of human subject protection education and training
that meets VA and Federal requirements</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="2" type="1">
<li><p>Identification of individuals for whom education and training is
required in compliance with VA and Federal requirements</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="3" type="1">
<li><p>Methods for confirming that individuals required to have
education and training by VA and Federal requirements have met
training.</p></li>
</ol></td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
</tr>
<tr class="odd">
<td colspan="4" rowspan="2"><p><strong>Scoring rules</strong>: 3 factors
= 100%;</p>
<p>2 factors = 50%; else 0%</p></td>
<td colspan="4">Possible points</td>
<td colspan="2">0.8</td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="4">Points earned</td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
</tr>
<tr class="odd">
<td colspan="8"><strong>Element INR 6B (page 24)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td><strong>N</strong></td>
<td colspan="2"><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="13"><ol type="1">
<li><p>All required individuals have been educated and/or trained in
Human Subject Protections in accordance with the institution's policies
and procedures.</p></li>
</ol></td>
<td rowspan="3"></td>
</tr>
<tr class="odd">
<td colspan="5" rowspan="2"><strong>Scoring rules</strong>: All
individuals trained = 100%; all investigators trained = 50%; else
0%</td>
<td colspan="3">Possible points</td>
<td colspan="2">2.0</td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="3">Points earned</td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
</tr>
<tr class="odd">
<td colspan="8"><strong>Element INR 6C (page 25)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td><strong>N</strong></td>
<td colspan="2"><strong>N/A</strong></td>
<td><strong> Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="13">The institution's guidance to investigators for the
process of informed consent:</td>
<td rowspan="13"><p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p></td>
</tr>
<tr class="odd">
<td colspan="8"><ol type="1">
<li><p>States that the IRB has the authority to observe the consent
process</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="2" type="1">
<li><p>States when the assessment of the subject's capacity to consent
to a research protocol is required</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="3" type="1">
<li><p>Identifies who, under VA policy, state and local law, may serve
as a legally authorized representative for subjects determined to be
incapable of making an autonomous decision</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="4" type="1">
<li><p>Identifies who is eligible to inform the prospective subject
about all aspects of the trial</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="5" type="1">
<li><p>Identifies who is eligible to conduct the informed consent
process</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="6" type="1">
<li><p>States that investigators must obtain consent prior to entering a
subject into a study and/or conducting any procedures required by the
protocol, unless consent is waived by the IRB</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="7" type="1">
<li><p>Includes processes for ensuring that information is given to the
subject, or their legally authorized representative, in a language that
is understandable to the subject or representative</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="8" type="1">
<li><p>Provides for the prospective subject or the legally authorized
representative to have sufficient opportunity to consider whether or not
to participate</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="8"><ol start="9" type="1">
<li><p>States that subjects must give consent without coercion or undue
influence</p></li>
</ol></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="8"><ol start="10" type="1">
<li><p>Has been in place for at least 12 months.</p></li>
</ol></td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
</tr>
<tr class="odd">
<td colspan="3" rowspan="2"><p><strong>Scoring rules</strong>: 10
factors = 100%;</p>
<p>8-9 factors = 75%; 6-7 factors = 50%;</p>
<p>else 0% </p></td>
<td colspan="5">Possible points</td>
<td colspan="2">0.8</td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="5">Points earned</td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
</tr>
<tr class="odd">
<td colspan="7"><strong>Element INR 6D (page 27)</strong></td>
<td colspan="2"><strong>Y</strong></td>
<td colspan="3"><h1 id="n">N</h1></td>
<td><strong>N/A</strong></td>
<td><strong>Source/ Comments</strong></td>
</tr>
<tr class="even">
<td colspan="13">The institution's guidance on informed consent
forms:</td>
<td rowspan="11"><p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p>
<p> </p></td>
</tr>
<tr class="odd">
<td colspan="7"><ol type="1">
<li><p>States that the informed consent form must be the VA Form
10-1086, approved by the IRB and signed by the subject or the subject's
legally authorized representative, except in cases where the
documentation of informed consent is waived by the IRB</p></li>
</ol></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="2" type="1">
<li><p>States that the consent form includes all basic elements of
information as set forth in VA and other Federal regulations</p></li>
</ol></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"><ol start="3" type="1">
<li><p>States that the consent form includes appropriate additional
elements of information as set forth in VA and other federal
regulations</p></li>
</ol></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="4" type="1">
<li><p>States that all information concerning payment to subjects,
including the amount and schedule of payments, be included in the
consent form</p></li>
</ol></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"><ol start="5" type="1">
<li><p>States that no informed consent, whether oral or written, may
include any exculpatory language through which the subject or the
legally authorized representative is made to waive or appear to waive
any of the subject's legal rights, or to release or appear to release
the investigator, the sponsor, the institution or its agents from
liability for negligence</p></li>
</ol></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="6" type="1">
<li><p>States that the content of consent forms must be consistent with
state laws regarding content</p></li>
</ol></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="7"><ol start="7" type="1">
<li><p>Requires that information be given to the subject, or the
subject's legally authorized representative, in a language that is
understandable to the subject or representative</p></li>
</ol></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7"><ol start="8" type="1">
<li><p>Has been in place for at least 12 months.</p></li>
</ol></td>
<td colspan="2"> </td>
<td colspan="3"> </td>
<td> </td>
</tr>
<tr class="odd">
<td rowspan="2"><p><strong>Scoring rules</strong>: 8 factors = 100%;</p>
<p>7 factors = 75%; 4-6 factors = 50%; else 0%</p></td>
<td colspan="6">Possible points</td>
<td colspan="2">0.8</td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="6">Points earned</td>
<td colspan="2"> </td>
<td colspan="3"> </td>
<td> </td>
</tr>
</tbody>
</table>

  ------------- ------------ -----------------------------------------------
  **INR                      
  Summary**                  

  **Element**   **Factor**   **Comments**

                             ** **

                             

                             

                             

                             

                             

                             

                             

                             

                             

                             

                             

                             

                             
  ------------- ------------ -----------------------------------------------