**Sample Clinical Quality Management Regulatory File Review Tool**

(SAMPLE ONLY. The template below is provided for your convenience as an
example of how this information may be provided. You may modify this as
appropriate.)

***Instructions: List the protocol number, the date range that is being
reviewed and the date of the review. Once the review begins, check the
appropriate boxes for each question listed in the criteria section. When
the review is completed for all applicable documents, the QA reviewer
will sign and date the form. Use the comments section for clarification
and action on any "no" entries checked.***

Site
Name\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Site Number\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of Reviewer\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date
of Review\_\_\_\_\_\_\_\_\_\_\_

Protocol Number\_\_\_\_\_\_\_\_\_\_Version #\_\_\_\_\_\_\_\_

Reviewed from (date)\_\_\_\_\_\_\_\_to (date)\_\_\_\_\_\_\_

+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   | P  |   |   |   |    |   |
|               |                                      |   | re |   |   |   |    |   |
|               |                                      |   | se |   |   |   |    |   |
|               |                                      |   | nt |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| *Document*    | *Criteria*                           |   | Y  | N |   |   | N  |   |
|               |                                      |   | es | o |   |   | /A |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| IRB/EC        | Approval?                            |   |    |   |   |   |    |   |
| approval      |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Other         | Approval?                            |   |    |   |   |   |    |   |
| Regulatory if |                                      |   |    |   |   |   |    |   |
| applicable    |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Informed Consent Approvals Present?  |   |    |   |   |   |    |   |
|               |                                      |   |    |   |   |   |    |   |
|               | Revision Approvals (if applicable)   |   |    |   |   |   |    |   |
|               | Present ?                            |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Continuing Approvals Present?        |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Approvals for all protocol           |   |    |   |   |   |    |   |
|               | amendments present?                  |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Communication and reports from       |   |    |   |   |   |    |   |
|               | IRB?EC and other regulatory bodies   |   |    |   |   |   |    |   |
|               | present?                             |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Other written material given to      |   |    |   |   |   |    |   |
|               | participants Approvals Present?      |   |    |   |   |   |    |   |
|               |                                      |   |    |   |   |   |    |   |
|               | Revision Approvals (if applicable)   |   |    |   |   |   |    |   |
|               | Present ?                            |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| DAIDS         | Is the DAIDS (RCC) approval for      |   |    |   |   |   |    |   |
| approvals     | protocol registration present?       |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Assurances    | Is there a current assurance         |   |    |   |   |   |    |   |
|               | document from OHRP present and not   |   |    |   |   |   |    |   |
|               | expired?                             |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Safety        | Are EAE reports present?             |   |    |   |   |   |    |   |
| Reports       |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Have these safety reports been       |   |    |   |   |   |    |   |
|               | submitted to IRB/IEC?                |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Are SAE, AE Local and Regional       |   |    |   |   |   |    |   |
|               | Reports present?                     |   |    |   |   |   |    |   |
|               |                                      |   |    |   |   |   |    |   |
|               | Have these been submitted to the     |   |    |   |   |   |    |   |
|               | IRB/EC?                              |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Protocol      | Is a current copy of the protocol on |   |    |   |   |   |    |   |
|               | file?                                |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Is the approved Master Informed      |   |    |   |   |   |    |   |
|               | Consent on file?                     |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Are all previous versions on file?   |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Case Report   | Are blank copies present?            |   |    |   |   |   |    |   |
| Forms         |                                      |   |    |   |   |   |    |   |
|               | Are blank copies of all revisions    |   |    |   |   |   |    |   |
|               | present?                             |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| 1572/IOR      | Is there a 1572 (for IND studies),   |   |    |   |   |   |    |   |
| agreement     | or an Investigator of Record         |   |    |   |   |   |    |   |
|               | Agreement on file?                   |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Is the document current and          |   |    |   |   |   |    |   |
|               | accurate?                            |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Is the PI CV on file and up to date? |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | PI CV/Biosketch on file, but not     |   |    |   |   |   |    |   |
|               | with Form 1572                       |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Other         |                                      |   |    |   |   |   |    |   |
| agreements    |                                      |   |    |   |   |   |    |   |
| (list)        |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| CVs           | Present for all key personnel and    |   |    |   |   |   |    |   |
| ;Biographical | current/updated?                     |   |    |   |   |   |    |   |
| Sketches;     |                                      |   |    |   |   |   |    |   |
| Licenses      |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Are GCP/HSP training certificates    |   |    |   |   |   |    |   |
|               | current and up-to-date?              |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Financial     | Are financial disclosure forms for   |   |    |   |   |   |    |   |
| D             | all key personnel present?           |   |    |   |   |   |    |   |
| isclosure/Job |                                      |   |    |   |   |   |    |   |
| description   |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | Are job descriptions for all         |   |    |   |   |   |    |   |
|               | personnel present?                   |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Site          | Are all visit reports present?       |   |    |   |   |   |    |   |
| Monitoring    |                                      |   |    |   |   |   |    |   |
| Visit Reports |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Investigator  | Are Investigator Brochures including |   |    |   |   |   |    |   |
| Brochures     | revisions and applicable package     |   |    |   |   |   |    |   |
|               | inserts present for investigational  |   |    |   |   |   |    |   |
|               | products?                            |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Laboratory    | Are laboratory certifications and    |   |    |   |   |   |    |   |
|               | normal ranges present for labs?      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               | For other labs in protocol, are      |   |    |   |   |   |    |   |
|               | there any required certificates      |   |    |   |   |   |    |   |
|               | present? (include updates)           |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Importation   | Are FDA import permits present and   |   |    |   |   |   |    |   |
|               | not expired?                         |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Signature     | Is the signature key present for all |   |    |   |   |   |    |   |
| Logs          | individuals authorized to make       |   |    |   |   |   |    |   |
|               | entries in study records?            |   |    |   |   |   |    |   |
|               |                                      |   |    |   |   |   |    |   |
|               | Are delegation of responsibility     |   |    |   |   |   |    |   |
|               | lists present?                       |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
|               |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+
| Other         |                                      |   |    |   |   |   |    |   |
| Documents     |                                      |   |    |   |   |   |    |   |
|               |                                      |   |    |   |   |   |    |   |
| Re            |                                      |   |    |   |   |   |    |   |
| viewed:(list) |                                      |   |    |   |   |   |    |   |
+---------------+--------------------------------------+---+----+---+---+---+----+---+

**Findings/Results of Review:**

Comments/Corrective action to follow up on any "no" entries :

+---------------------------------------------------+------------------+
| #                                                 | ## C             |
|                                                   | orrected by/date |
| ***Problem***                                     |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+
|                                                   |                  |
+---------------------------------------------------+------------------+

Signature of
Reviewer\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date\_\_\_\_\_\_\_\_\_\_\_\_\_