<table style="width:100%;">
<colgroup>
<col style="width: 13%" />
<col style="width: 1%" />
<col style="width: 19%" />
<col style="width: 13%" />
<col style="width: 4%" />
<col style="width: 1%" />
<col style="width: 4%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 19%" />
<col style="width: 13%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="2"><h3 id="reviewer-name"
class="Style-Heading-3-+-11-pt-Not-Italic">Reviewer Name:</h3></td>
<td><h3 id="section"
class="Style-Heading-3-+-11-pt-Not-Italic"></h3></td>
<td colspan="2"><h3 id="date-of-review"
class="Style-Heading-3-+-11-pt-Not-Italic">Date of Review:</h3></td>
<td colspan="6"><h3 id="section-1"
class="Style-Heading-3-+-11-pt-Not-Italic"></h3></td>
</tr>
<tr class="even">
<td colspan="2"><h3 id="protocol-number"
class="Style-Heading-3-+-11-pt-Not-Italic">Protocol Number:</h3></td>
<td><h3 id="section-2"
class="Style-Heading-3-+-11-pt-Not-Italic"></h3></td>
<td colspan="2"><h3 id="reviewed-from-date"
class="Style-Heading-3-+-11-pt-Not-Italic">Reviewed From Date:</h3></td>
<td colspan="4"><h3 id="section-3"
class="Style-Heading-3-+-11-pt-Not-Italic"></h3></td>
<td><h3 id="reviewed-through-date"
class="Style-Heading-3-+-11-pt-Not-Italic">Reviewed Through
Date:</h3></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="11"><strong>Instructions:</strong> This sample Regulatory
File Review Tool, along with the DMID and ICH Regulatory File Guidelines
(site ICH section 8), is recommended for reviewing regulatory files for
each protocol. Review of the regulatory file should be completed at a
minimum <em>once</em> during the active study period <em>or
annually</em> if the study is long term. For each criteria reviewed in
Section I, check the appropriate boxes. Any issues (‘No’ indications or
comments) noted within Section I are summarized in Section II including
the resolution to the issue(s) / corrective action, date resolved, and
the name of the individual responsible for corrections. When the review
and any corrective actions are completed, this Regulatory File Review
Tool will be signed and dated by the QA Reviewer and filed within the
Quality Management binder. Note: Other protocol-specific indicators or
criteria may be added as determined by site staff.</td>
</tr>
<tr class="even">
<td colspan="11"><h3 id="section-i-documents-and-criteria"
class="Style-Heading-3-+-11-pt-Not-Italic">SECTION I – DOCUMENTS AND
CRITERIA</h3></td>
</tr>
<tr class="odd">
<td><h3 id="document"
class="Style-Heading-3-+-11-pt-Not-Italic">Document</h3></td>
<td colspan="3"><h3 id="criteria"
class="Style-Heading-3-+-11-pt-Not-Italic">Criteria</h3></td>
<td colspan="2"><h3 id="yes"
class="Style-Heading-3-+-11-pt-Not-Italic">YES</h3>
<h3 id="section-4"
class="Style-Heading-3-+-11-pt-Not-Italic">√</h3></td>
<td><h3 id="no" class="Style-Heading-3-+-11-pt-Not-Italic">NO</h3>
<h3 id="section-5"
class="Style-Heading-3-+-11-pt-Not-Italic">√</h3></td>
<td><h3 id="na" class="Style-Heading-3-+-11-pt-Not-Italic">N/A</h3>
<h3 id="section-6"
class="Style-Heading-3-+-11-pt-Not-Italic">√</h3></td>
<td colspan="3"><h3 id="comments"
class="Style-Heading-3-+-11-pt-Not-Italic">Comments</h3></td>
</tr>
<tr class="even">
<td><strong>Study Identification</strong></td>
<td colspan="3">Is the identification of the site, including name of PI,
study location(s), DMID, Protocol Number and title, etc. present and
correct?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td rowspan="4"><strong>IRB/IEC Approvals</strong></td>
<td colspan="3">Is the Initial IRB/IEC Approval for the Protocol and the
Informed Consent present?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="3">Are subsequent approvals present (i.e., Continuing /
Annual Review, amendments)</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td colspan="3">Are all applicable Advertisements, Recruitment Scripts,
Participant Information Materials approved by the IRB/IEC and on
file?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="3">Are periodic Reports present?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td rowspan="2"><strong>IRB/IEC Membership</strong></td>
<td colspan="3">Is the IRB Roster or Membership composition on file? Has
it been updated annually?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="3">If the IRB does not provide a roster, is there a letter
on file stating the names are not released?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td><strong>Foreign Regulatory Approvals</strong></td>
<td colspan="3">If this is a non-U.S. site, is there documentation of
foreign regulatory body approval or clearance on file?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td><strong>Local Regulatory Approvals</strong></td>
<td colspan="3">Are all local, state, and/or special authorizations
related to the protocol maintained and up-to-date?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td><strong>Federal Wide Assurances (FWA)</strong></td>
<td colspan="3">Is there a current Federal Wide Assurance document from
OHRP present? Is the expiration date present?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="3"></td>
</tr>
</tbody>
</table>

+--------+-----------------------+---+---+---+---+-------------------------+
| ### S  |                       |   |   |   |   |                         |
| ECTION |                       |   |   |   |   |                         |
|  I --  |                       |   |   |   |   |                         |
| DOCUME |                       |   |   |   |   |                         |
| NTS AN |                       |   |   |   |   |                         |
| D CRIT |                       |   |   |   |   |                         |
| ERIA ( |                       |   |   |   |   |                         |
| cont.) |                       |   |   |   |   |                         |
|  {#sec |                       |   |   |   |   |                         |
| tion-i |                       |   |   |   |   |                         |
| -docum |                       |   |   |   |   |                         |
| ents-a |                       |   |   |   |   |                         |
| nd-cri |                       |   |   |   |   |                         |
| teria- |                       |   |   |   |   |                         |
| cont.  |                       |   |   |   |   |                         |
| .Style |                       |   |   |   |   |                         |
| -Headi |                       |   |   |   |   |                         |
| ng-3-+ |                       |   |   |   |   |                         |
| -11-pt |                       |   |   |   |   |                         |
| -Not-I |                       |   |   |   |   |                         |
| talic} |                       |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
| ##     | ### Criteria {#crite  |   | # | # | # | ### Comments {#c        |
| # Docu | ria-1 .Style-Heading- |   | # | # | # | omments-1 .Style-Headin |
| ment { | 3-+-11-pt-Not-Italic} |   | # | # | # | g-3-+-11-pt-Not-Italic} |
| #docum |                       |   |   |   |   |                         |
| ent-1  |                       |   | Y | N | N |                         |
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| talic} |                       |   | y | o | n |                         |
|        |                       |   | e | - | a |                         |
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|        |                       |   | 1 | . |   |                         |
|        |                       |   |   | S | . |                         |
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|        |                       |   | t | l | y |                         |
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|        |                       |   | e | H | - |                         |
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|        |                       |   | e | d | a |                         |
|        |                       |   | a | i | d |                         |
|        |                       |   | d | n | i |                         |
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|        |                       |   | N | t | o |                         |
|        |                       |   | o | - | t |                         |
|        |                       |   | t | I | - |                         |
|        |                       |   | - | t | I |                         |
|        |                       |   | I | a | t |                         |
|        |                       |   | t | l | a |                         |
|        |                       |   | a | i | l |                         |
|        |                       |   | l | c | i |                         |
|        |                       |   | i | } | c |                         |
|        |                       |   | c |   | } |                         |
|        |                       |   | } | # |   |                         |
|        |                       |   |   | # | # |                         |
|        |                       |   | # | # | # |                         |
|        |                       |   | # |   | # |                         |
|        |                       |   | # | √ |   |                         |
|        |                       |   |   |   | √ |                         |
|        |                       |   | √ | { |   |                         |
|        |                       |   |   | # | { |                         |
|        |                       |   | { | s | # |                         |
|        |                       |   | # | e | s |                         |
|        |                       |   | s | c | e |                         |
|        |                       |   | e | t | c |                         |
|        |                       |   | c | i | t |                         |
|        |                       |   | t | o | i |                         |
|        |                       |   | i | n | o |                         |
|        |                       |   | o | - | n |                         |
|        |                       |   | n | 8 | - |                         |
|        |                       |   | - |   | 9 |                         |
|        |                       |   | 7 | . |   |                         |
|        |                       |   |   | S | . |                         |
|        |                       |   | . | t | S |                         |
|        |                       |   | S | y | t |                         |
|        |                       |   | t | l | y |                         |
|        |                       |   | y | e | l |                         |
|        |                       |   | l | - | e |                         |
|        |                       |   | e | H | - |                         |
|        |                       |   | - | e | H |                         |
|        |                       |   | H | a | e |                         |
|        |                       |   | e | d | a |                         |
|        |                       |   | a | i | d |                         |
|        |                       |   | d | n | i |                         |
|        |                       |   | i | g | n |                         |
|        |                       |   | n | - | g |                         |
|        |                       |   | g | 3 | - |                         |
|        |                       |   | - | - | 3 |                         |
|        |                       |   | 3 | + | - |                         |
|        |                       |   | - | - | + |                         |
|        |                       |   | + | 1 | - |                         |
|        |                       |   | - | 1 | 1 |                         |
|        |                       |   | 1 | - | 1 |                         |
|        |                       |   | 1 | p | - |                         |
|        |                       |   | - | t | p |                         |
|        |                       |   | p | - | t |                         |
|        |                       |   | t | N | - |                         |
|        |                       |   | - | o | N |                         |
|        |                       |   | N | t | o |                         |
|        |                       |   | o | - | t |                         |
|        |                       |   | t | I | - |                         |
|        |                       |   | - | t | I |                         |
|        |                       |   | I | a | t |                         |
|        |                       |   | t | l | a |                         |
|        |                       |   | a | i | l |                         |
|        |                       |   | l | c | i |                         |
|        |                       |   | i | } | c |                         |
|        |                       |   | c |   | } |                         |
|        |                       |   | } |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
| ### Pr | Is a current and      |   |   |   |   |                         |
| otocol | valid copy of the     |   |   |   |   |                         |
|        | Protocol on file?     |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
|        | Are all previous      |   |   |   |   |                         |
|        | versions of the       |   |   |   |   |                         |
|        | Protocol on file?     |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
|        | Have any lapses been  |   |   |   |   |                         |
|        | documented properly?  |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
| ###    | Is a current and      |   |   |   |   |                         |
| Inform | valid copy of the     |   |   |   |   |                         |
| ed Con | Informed Consent Form |   |   |   |   |                         |
| sent F | on file?              |   |   |   |   |                         |
| orm(s) |                       |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
|        | Are all previous      |   |   |   |   |                         |
|        | versions of the       |   |   |   |   |                         |
|        | Informed Consent Form |   |   |   |   |                         |
|        | on file?              |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
|        | Have any lapses been  |   |   |   |   |                         |
|        | documented properly?  |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
| ###    | Is there a 1572 (for  |   |   |   |   |                         |
| 1572/I | IND studies), or an   |   |   |   |   |                         |
| OR Agr | Investigator of       |   |   |   |   |                         |
| eement | Record Agreement on   |   |   |   |   |                         |
|        | file?                 |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
|        | Is the agreement      |   |   |   |   |                         |
|        | current and accurate? |   |   |   |   |                         |
|        | Has the agreement     |   |   |   |   |                         |
|        | been signed by PI?    |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
| ##     | Are all SAEs that     |   |   |   |   |                         |
| # Seri | have been reported to |   |   |   |   |                         |
| ous Ad | the DMID and IRB/IEC  |   |   |   |   |                         |
| verse  | present in the file?  |   |   |   |   |                         |
| Events |                       |   |   |   |   |                         |
|  (SAE) |                       |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
| ### Sa | Are Safety            |   |   |   |   |                         |
| fety R | Reports/Memos for     |   |   |   |   |                         |
| eports | this protocol on      |   |   |   |   |                         |
|        | file?                 |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
|        | Have these safety     |   |   |   |   |                         |
|        | reports been          |   |   |   |   |                         |
|        | submitted to IRB/IEC? |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
| ###    | Does the file contain |   | [ | [ | [ | []{.mark}               |
| Study- | the study-specific    |   | ] | ] | ] |                         |
| specif | procedures or the     |   | { | { | { |                         |
| ic Pro | Manual of Procedures  |   | . | . | . |                         |
| cedure | (MOP)?                |   | m | m | m |                         |
| s / Ma |                       |   | a | a | a |                         |
| nual o |                       |   | r | r | r |                         |
| f Proc |                       |   | k | k | k |                         |
| edures |                       |   | } | } | } |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
| ##     | Are final (actually   |   | [ | [ | [ | []{.mark}               |
| # Samp | used) versions of the |   | ] | ] | ] |                         |
| le Cas | sample CRF(s) or      |   | { | { | { |                         |
| e Repo | other forms used for  |   | . | . | . |                         |
| rt For | entering data on      |   | m | m | m |                         |
| ms (CR | file?                 |   | a | a | a |                         |
| F) / e |                       |   | r | r | r |                         |
| CRF(s) |                       |   | k | k | k |                         |
|        |                       |   | } | } | } |                         |
+--------+-----------------------+---+---+---+---+-------------------------+
|        | Are final (actually   |   |   |   |   |                         |
|        | used) versions of the |   |   |   |   |                         |
|        | Source Document       |   |   |   |   |                         |
|        | Workbook (eCRF) that  |   |   |   |   |                         |
|        | is provided by the    |   |   |   |   |                         |
|        | sponsor on file?      |   |   |   |   |                         |
|        | Note: Dated           |   |   |   |   |                         |
|        | documentation of all  |   |   |   |   |                         |
|        | changes to the        |   |   |   |   |                         |
|        | database during the   |   |   |   |   |                         |
|        | active period of the  |   |   |   |   |                         |
|        | trial must be         |   |   |   |   |                         |
|        | maintained.           |   |   |   |   |                         |
+--------+-----------------------+---+---+---+---+-------------------------+

<table style="width:100%;">
<colgroup>
<col style="width: 13%" />
<col style="width: 33%" />
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 4%" />
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 36%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="10"><h3 id="section-i-documents-and-criteria-cont.-1"
class="Style-Heading-3-+-11-pt-Not-Italic">SECTION I – DOCUMENTS AND
CRITERIA (cont.)</h3></td>
</tr>
<tr class="even">
<td><h3 id="document-2">Document</h3></td>
<td><h3 id="criteria-2">Criteria</h3></td>
<td colspan="2"><h3 id="yes-2">Yes</h3>
<h3 id="section-10">√</h3></td>
<td colspan="2"><h3 id="no-2">No</h3>
<h3 id="section-11">√</h3></td>
<td colspan="2"><h3 id="na-2">N/A</h3>
<h3 id="section-12">√</h3></td>
<td colspan="2"><h3 id="comments-2">Comments</h3></td>
</tr>
<tr class="odd">
<td><h3 id="curricula-vitae-cvs">Curricula Vitae (CVs)</h3></td>
<td colspan="2"><p>Are CVs present for Principal Investigator and all
sub-investigators listed on the 1572/IOR? Are they current? (&lt; 5
years of current date)</p>
<p>Basic requirements of the CV include current work address,
professional title, degrees, and current relevant licensure.</p></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="medical-licenses">Medical Licenses</h3></td>
<td colspan="2">Are Medical Licenses present for Principal Investigator
and all sub-investigators listed on the 1572/IOR? Are they current?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="protocol-deviations">Protocol Deviations</h3></td>
<td colspan="2">Are all Protocol Deviations that have been submitted to
the IRB/IEC present?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><mark></mark></td>
</tr>
<tr class="even">
<td><h3 id="financial-disclosure">Financial Disclosure</h3></td>
<td colspan="2">Are financial disclosure forms for all key personnel
present?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td rowspan="2"><h3
id="investigator-brochures-package-inserts">Investigator Brochures /
Package Inserts</h3></td>
<td colspan="2">Are Investigator Brochures present, current, and
available for investigational products? Have these been submitted to the
IRB (if applicable)?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Are package inserts present, current, and available for
approved drugs? Have these been submitted to the IRB (if
applicable)?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td rowspan="4"><h3
id="laboratory-normals-and-accreditations">Laboratory Normals and
Accreditations</h3></td>
<td colspan="2">Are laboratory certifications and accreditations present
for U.S. labs? (CAP and CLIA Accreditation, JCAHO, CLIA Compliance, CLIA
exempt, etc.)</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">If not a U.S. lab, are there other certificates of
qualification for the lab on file? If not, is a statement included
explaining the reason and a description of the standard being used?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2">Are approvals from collaborating Research Laboratories
on file?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Are Normal Ranges for all protocol-required tests on
file? This must include all clinical laboratory tests required by the
protocol, the unit of measure, the laboratory name, and the date of the
document.</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
</tbody>
</table>

<table style="width:100%;">
<colgroup>
<col style="width: 13%" />
<col style="width: 33%" />
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 4%" />
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 36%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="10"><h3 id="section-i-documents-and-criteria-cont.-2"
class="Style-Heading-3-+-11-pt-Not-Italic">SECTION I – DOCUMENTS AND
CRITERIA (cont.)</h3></td>
</tr>
<tr class="even">
<td><h3 id="document-3">Document</h3></td>
<td><h3 id="criteria-3">Criteria</h3></td>
<td colspan="2"><h3 id="yes-3">Yes</h3>
<h3 id="section-13">√</h3></td>
<td colspan="2"><h3 id="no-3">No</h3>
<h3 id="section-14">√</h3></td>
<td colspan="2"><h3 id="na-3">N/A</h3>
<h3 id="section-15">√</h3></td>
<td colspan="2"><h3 id="comments-3">Comments</h3></td>
</tr>
<tr class="odd">
<td rowspan="6"><h3 id="test-article">Test Article</h3></td>
<td colspan="2">Is there a sample Test Article label on file?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Are the Test Article Accountability Records accurate,
current, and on file? Do they agree with the actual inventory on
hand?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2">Are instructions (protocol-specific MOP) for the
storage, mixing, and handling of Test Article easily accessible and on
file?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td><mark></mark></td>
</tr>
<tr class="even">
<td colspan="2">Are Shipping Records for Test Article documenting the
receipt date, quantity, lot numbers of all test articles (if open-label
study) on file?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2">Is the randomization list and decoding procedures for
Blinded Test Article on file?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Are Test Article Temperature Logs on file?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="specimen-retention">Specimen Retention</h3></td>
<td colspan="2">Are Specimen Retention Records on file?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="site-monitoring-log-and-reports">Site Monitoring Log and
Reports</h3></td>
<td colspan="2">Are copies of Site Monitoring Logs and Reports on file?
(Initiation, Interim Monitoring, Close-out)</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="study-personnel-signature-responsibility-list">Study
Personnel Signature/ Responsibility List</h3></td>
<td colspan="2">Is the Study Personnel Signature/Responsibility List
present for all individuals authorized to make entries in study
records?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="id-code-list">ID Code List</h3></td>
<td colspan="2">Is the ID Code List present in the file?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="screening-enrollment-log">Screening/ Enrollment
Log</h3></td>
<td colspan="2">Is the Screening/Enrollment Log present and
up-to-date?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="sponsor-correspondence">Sponsor Correspondence</h3></td>
<td colspan="2">Does the file contain all up-to-date correspondence
between the site and sponsor?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="internal-correspondence">Internal Correspondence</h3></td>
<td colspan="2">Does the file contain all up-to-date internal
correspondence?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td><h3 id="telephone-contact-reports">Telephone Contact
Reports</h3></td>
<td colspan="2">Does the file contain up-to-date Telephone Contact
Reports?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td><h3 id="regulatory-review-history">Regulatory Review
History</h3></td>
<td colspan="2">Does the file contain an up-to-date Regulatory Review
History Form?</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
</tbody>
</table>

###   {#section-16 .Style-Heading-3-+-11-pt-Not-Italic}

+--------+-----------------------+---+---+---+-------------------------+
| #      |                       |   |   |   |                         |
| ## SEC |                       |   |   |   |                         |
| TION I |                       |   |   |   |                         |
|  -- DO |                       |   |   |   |                         |
| CUMENT |                       |   |   |   |                         |
| S AND  |                       |   |   |   |                         |
| CRITER |                       |   |   |   |                         |
| IA (co |                       |   |   |   |                         |
| nt.) { |                       |   |   |   |                         |
| #secti |                       |   |   |   |                         |
| on-i-d |                       |   |   |   |                         |
| ocumen |                       |   |   |   |                         |
| ts-and |                       |   |   |   |                         |
| -crite |                       |   |   |   |                         |
| ria-co |                       |   |   |   |                         |
| nt.-3  |                       |   |   |   |                         |
| .Style |                       |   |   |   |                         |
| -Headi |                       |   |   |   |                         |
| ng-3-+ |                       |   |   |   |                         |
| -11-pt |                       |   |   |   |                         |
| -Not-I |                       |   |   |   |                         |
| talic} |                       |   |   |   |                         |
+--------+-----------------------+---+---+---+-------------------------+
| Do     | ### C                 | # | # | # | ###                     |
| cument | riteria {#criteria-4} | # | # | # |  Comments {#comments-4} |
|        |                       | # | # | # |                         |
|        |                       |   |   |   |                         |
|        |                       | Y | N | N |                         |
|        |                       | e | o | / |                         |
|        |                       | s |   | A |                         |
|        |                       |   | { |   |                         |
|        |                       | { | # | { |                         |
|        |                       | # | n | # |                         |
|        |                       | y | o | n |                         |
|        |                       | e | - | a |                         |
|        |                       | s | 4 | - |                         |
|        |                       | - | } | 4 |                         |
|        |                       | 4 |   | } |                         |
|        |                       | } | # |   |                         |
|        |                       |   | # | # |                         |
|        |                       | # | # | # |                         |
|        |                       | # |   | # |                         |
|        |                       | # | √ |   |                         |
|        |                       |   |   | √ |                         |
|        |                       | √ | { |   |                         |
|        |                       |   | # | { |                         |
|        |                       | { | s | # |                         |
|        |                       | # | e | s |                         |
|        |                       | s | c | e |                         |
|        |                       | e | t | c |                         |
|        |                       | c | i | t |                         |
|        |                       | t | o | i |                         |
|        |                       | i | n | o |                         |
|        |                       | o | - | n |                         |
|        |                       | n | 1 | - |                         |
|        |                       | - | 8 | 1 |                         |
|        |                       | 1 | } | 9 |                         |
|        |                       | 7 |   | } |                         |
|        |                       | } |   |   |                         |
+--------+-----------------------+---+---+---+-------------------------+
| ### F  | If applicable, is the |   |   |   |                         |
| inal R | Final Report to the   |   |   |   |                         |
| eports | IRB/IEC present?      |   |   |   |                         |
+--------+-----------------------+---+---+---+-------------------------+
|        | If applicable, is the |   |   |   |                         |
|        | Final Report to the   |   |   |   |                         |
|        | sponsor present?      |   |   |   |                         |
+--------+-----------------------+---+---+---+-------------------------+
| ### N  | Does the file contain |   |   |   |                         |
| otes t | relevant              |   |   |   |                         |
| o File | study-specific notes  |   |   |   |                         |
|        | to file?              |   |   |   |                         |
+--------+-----------------------+---+---+---+-------------------------+

###  {#section-20 .Style-Heading-3-+-11-pt-Not-Italic}

###  {#section-21 .Style-Heading-3-+-11-pt-Not-Italic}

+-----------------------------------------------------+-------+-------+
| ### SECTIO                                          |       |       |
| N II -- ISSUES AND RESOLUTIONS (CORRECTIVE ACTION T |       |       |
| AKEN) {#section-ii-issues-and-resolutions-correctiv |       |       |
| e-action-taken .Style-Heading-3-+-11-pt-Not-Italic} |       |       |
+-----------------------------------------------------+-------+-------+
| ### Issues and Corrective Actions Noted R           | ##    | ##    |
| ecommend a separate column for corrective actions.  | # Dat | # Res |
|                                                     | e Res | olved |
| ### (refer to "comments" in above Section I)        | olved |  by ( |
|                                                     |       | Name) |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+
|                                                     |       |       |
+-----------------------------------------------------+-------+-------+

**Quality Assurance Review Completion:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

> **Signature of Person Performing QA Review**