+---------+-------------------------+---+----------+----+--------------+
| **Grant | Unfunded (part of large |   | **Res    | t  |              |
| \#**    | international           |   | ponsible | he |              |
|         | cooperative project)    |   | Org.**   | Am |              |
|         |                         |   |          | er |              |
|         |                         |   |          | ic |              |
|         |                         |   |          | an |              |
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|         |                         |   |          | ol |              |
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|         |                         |   |          | of |              |
|         |                         |   |          | R  |              |
|         |                         |   |          | he |              |
|         |                         |   |          | um |              |
|         |                         |   |          | at |              |
|         |                         |   |          | ol |              |
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|         |                         |   |          | y, |              |
|         |                         |   |          | E  |              |
|         |                         |   |          | UL |              |
|         |                         |   |          | AR |              |
+---------+-------------------------+---+----------+----+--------------+
| **      | International Myositis  |   |          |    |              |
| Project | Classification Criteria |   |          |    |              |
| Title** | Project (IMCCP)         |   |          |    |              |
+---------+-------------------------+---+----------+----+--------------+
| **Prin  | Name xxxxxx             | P |          |    |              |
| cipal** |                         | h |          |    |              |
|         | Title                   | o |          |    |              |
| **      |                         | n |          |    |              |
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| gator** |                         | x |          |    |              |
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|         |                         | ) |          |    |              |
+---------+-------------------------+---+----------+----+--------------+
| **Sp    | **Regulatory Sponsor /  | # |          |    | **(list      |
| onsor** | IND or IDE holder:**    | # |          |    | all)**       |
|         |                         |   |          |    |              |
|         | Name American College   | F |          |    | N/A          |
|         | of Rheumatology         | u |          |    |              |
|         |                         | n |          |    |              |
|         | Address 1800 Century    | d |          |    |              |
|         | Place, Suite 250        | i |          |    |              |
|         |                         | n |          |    |              |
|         | City/State/Zip Atlanta, | g |          |    |              |
|         | GA 30345-4300           |   |          |    |              |
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|         |                         | o |          |    |              |
|         |                         | n |          |    |              |
+---------+-------------------------+---+----------+----+--------------+

Please answer ALL of the following questions. Does this protocol contain
or involve:

+-------------------------------------------------------------+---------+
| 1.  Administration of questionnaire, personality tests,     | **X**   |
|     quality of life assessment or other surveys or          | Yes No  |
|     inventories?                                            |         |
|                                                             |         |
|     -   **IF YES**, provide name and [**two copies** if     |         |
|         using an approved standard                          |         |
|         instrument/questionnaire]{.underline} OR [**the     |         |
|         number of copies indicated at the end of this form  |         |
|         (full-board vs. expedited review)** of study or     |         |
|         project specific proposed survey or questionnaire   |         |
|         or other non-standardized test]{.underline} as part |         |
|         of the IRB submission packet.                       |         |
+-------------------------------------------------------------+---------+
| 2.  Research subjects receiving any radiation exposure      | Yes     |
|     (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, FDG, Tc-99m, | **X**   |
|     etc.) that they would not receive if they were not      | No      |
|     enrolled in this protocol?                              |         |
|                                                             |         |
|     -   **IF YES**, Protocol and Consent form submitted to  |         |
|         RDRC/EHRS                                           |         |
|                                                             |         |
| > Copy of Approval Letter Attached                          |         |
| >                                                           |         |
| > If you have questions, call **215-898-7187.**             |         |
+-------------------------------------------------------------+---------+
| 3.  Gene transfer (including all vectors) to human          | Yes     |
|     subjects?                                               | **X**   |
|                                                             | No      |
|     -   **IF YES**, the [protocol must be approved by the   |         |
|         Institutional Biosafety Committee]{.underline}.     |         |
|         Consult EHRS website:                               |         |
|         [www.ehrs.upenn.edu/protocols/bio_humans            |         |
| .html](http://www.ehrs.upenn.edu/protocols/bio_humans.html) |         |
|         for submission requirements.                        |         |
|                                                             |         |
| > If you have questions, call **215-898-4453.**             |         |
+-------------------------------------------------------------+---------+
| 4.  Drawing or use of human source material (i.e., human    | Yes     |
|     blood, blood products, tissues or body fluids)?         | **X**   |
|                                                             | No      |
|     -   **IF YES**, consult the EHRS web site:              |         |
|         [www.ehrs.upenn.edu/programs/bio/bbpathogens.htm    |         |
| l](http://www.ehrs.upenn.edu/programs/bio/bbpathogens.html) |         |
|         for information on OSHA Blood borne Pathogens       |         |
|         requirements (training, vaccination, work practices |         |
|         and Exposure Control Plan).                         |         |
|                                                             |         |
| > If you have questions, call **215-898-4453.**             |         |
+-------------------------------------------------------------+---------+
| 5.  Magnetic Resonance Imaging Center (CAMRIS) and MRI      | Yes     |
|     studies that research subjects would not receive if     | **X**   |
|     they were not part of this protocol?                    | No      |
|                                                             |         |
|     -   **IF YES,** consult CAMRIS website:                 |         |
|         [www.m                                              |         |
| mrrcc.upenn.edu/CAMRIS](http://www.mmrrcc.upenn.edu/CAMRIS) |         |
|         for application requirements                        |         |
+-------------------------------------------------------------+---------+
| 6.  Research project involves the use of an investigational | Yes     |
|     agent or device within the Operating Room?              | **X**   |
|                                                             | No      |
|     -   **IF YES,** contact Associate Executive Director,   |         |
|         Surgical Services: **(215) 662-2089**               |         |
+-------------------------------------------------------------+---------+
| 7.  Study will be conducted under an **IND**                | Yes     |
|     (Investigational New Drug Application) or an **IDE**    | **X**   |
|     (Investigational Device Exemption)?                     | No      |
|                                                             |         |
| -   **IF YES,** IND \#       or IDE \#       or 510k        |         |
|     submission #:                                           |         |
|                                                             |         |
|     -   **IF YES,** attach the appropriate number of        |         |
|         **copies of the Drug or Device Brochure, or an FDA  |         |
|         approved labeling** (these items will not be        |         |
|         returned to you) as indicated at the end of this    |         |
|         form (full-board vs. expedited review).             |         |
|                                                             |         |
| > **IF NO,** and the study involves use of FDA approved     |         |
| > drug(s) or device(s) in any manner listed below, the IRB  |         |
| > requires attached [documentation of IND                   |         |
| > exemption]{.underline} from FDA or OHR (Upenn Office of   |         |
| > Human Research).                                          |         |
| >                                                           |         |
| > Drugs or products administered to subjects not indicated  |         |
| > in the labeling.                                          |         |
| >                                                           |         |
| > Drugs administered to subjects in combination with other  |         |
| > drugs that is not considered standard of care.            |         |
| >                                                           |         |
| > Drugs, products or devices prepared in a manner not in    |         |
| > the labeling.                                             |         |
| >                                                           |         |
| > Any questions, call OHR: **215-746-7400**                 |         |
+-------------------------------------------------------------+---------+

+-------------------------------------------------------------+---------+
| 8.  Will Clinical Investigational materials involve any     | Yes     |
|     in-house manufacturing (including investigational       | **X**   |
|     cellular preparations), or processing (such as over     | No      |
|     encapsulating, or compounding),                         |         |
|                                                             |         |
| > 8a. What is the source of the Investigational material?   |         |
| > (check all that apply)                                    |         |
|                                                             |         |
| Supplied by license holder or funding agency Purchased      |         |
| Manufactured for this study                                 |         |
+-------------------------------------------------------------+---------+
| 9.  For research involving drugs, herbal products, or other | Yes     |
|     chemical entities administered to human subjects,       | **X**   |
|     obtain a registration number if the test materials will | No      |
|     be processed, distributed, blinded and accounted for    |         |
|     through the Investigational Drug Service (IDS) by       |         |
|     calling (215) 349-8817.                                 |         |
|                                                             |         |
| > **IDS Registration #:**                                   |         |
| >                                                           |         |
| > **Note:** The study protocol must describe the storage,   |         |
| > handling, administration and test material accountability |         |
| > tracking that will be maintained in the study.            |         |
+-------------------------------------------------------------+---------+
| 10. Has the Principal Investigator taken the on-line        | **X**   |
|     Patient Oriented Research training (questions call OHR: | Yes No  |
|     215-746-7400)                                           |         |
|                                                             |         |
|     -   **IF YES,** attach copy of certification. (required |         |
|         by School of Medicine for all SOM Faculty)          |         |
|                                                             |         |
| > 10a. List all study team members (Sub-investigators,      |         |
| > Coordinators) and anyone involved with the conduct of the |         |
| > study. If more than 5 names, attach a separate sheet:     |         |
|                                                             |         |
| ##  Name Role POR training?                                 |         |
|                                                             |         |
| > Sub-Investigator                                          |         |
| >                                                           |         |
| >                                                           |         |
| >                                                           |         |
| >                                                           |         |
| >                                                           |         |
| >                                                           |         |
| >                                                           |         |
| >                                                           |         |
+-------------------------------------------------------------+---------+
| 11. Does the research proposal involve the use and          | **X**   |
|     disclosure of research subject's medical information    | Yes No  |
|     for research purposes?                                  |         |
|                                                             |         |
| > 11a**. IF YES**, please check the box next to one of the  |         |
| > following that is provided with this submission:          |         |
| >                                                           |         |
| > Separate authorization for use and disclosure of          |         |
| > identifiable health information.                          |         |
| >                                                           |         |
| > **X** Modified research informed consent document that    |         |
| > incorporates HIPAA requirements.                          |         |
+-------------------------------------------------------------+---------+
| 12. Do you or any member of your research group, spouses or | Yes     |
|     any dependent children have any interest (i.e. any      | **X**   |
|     property of financial interest including stock in the   | No      |
|     sponsor company, patents, trademarks, copyrights or     |         |
|     licensing, supplemental research grants or consulting   |         |
|     arrangements) in the test drug/product, device, or      |         |
|     research procedure that is the subject of this study?   |         |
|                                                             |         |
|     -   **IF YES, please complete a Conflict of Interest    |         |
|         Disclosure Form available through the Office of     |         |
|         Research Services and submit one copy to the Office |         |
|         of Regulatory Affairs (ORA).** Please discuss how   |         |
|         these conflicts will be managed during the period   |         |
|         of the trial. Include language disclosing such      |         |
|         interest in the consent form for the use by         |         |
|         research subjects.                                  |         |
|                                                             |         |
| > 12a. In addition, for industry-sponsored trials, please   |         |
| > attach the documentation submitted to the sponsor as      |         |
| > required by 21CFR54.1, if applicable.                     |         |
+-------------------------------------------------------------+---------+
| 13. Please indicate the applicable research committee(s)    |         |
|     for this study, and status of any required approval(s): |         |
|                                                             |         |
| **Applicable? Research Committee Approval Status**          |         |
|                                                             |         |
| **Not sent Pending Approved N/A**                           |         |
|                                                             |         |
| > **X** Yes No Clinical Trials Scientific Review and        |         |
| > Monitoring Committee (UPCC)\*                             |         |
| >                                                           |         |
| > Yes **X** No GCRC Scientific Advisory Committee           |         |
| >                                                           |         |
| > Yes **X** No Radiation Safety Committee                   |         |
| >                                                           |         |
| > Yes **X** No CAMRIS                                       |         |
| >                                                           |         |
| > Yes **X** No Biosafety Committee                          |         |
+-------------------------------------------------------------+---------+

\*Clinical Trials Scientific Review and Monitoring Committee review and
approval is required for all clinical studies involving cancer patients
at the University of Pennsylvania that are not monitored under a
cooperative group such as ECOG, GOG, RTOG and NABTT.

+-----------------------------------------------------------------------+
| 14. Human subjects or material involved in the proposed activity      |
|     include any of the following special populations/categories:      |
|                                                                       |
| > Minors **X** Pregnant Women Prisoners Fetuses                       |
| >                                                                     |
| > Mentally disabled or cognitively impaired subjects **X** Employees  |
| > or                                                                  |
| >                                                                     |
| > **X** HIV-positive subjects                                         |
| >                                                                     |
| > **NONE** **of the above listed special populations/categories**     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ## REQUIRED S                                                         |
| IGNATURES: The department chair's signature for the individual depart |
| ment's with faculty participating in this study in addition to the pr |
| incipal investigator and principal investigator's department chair's  |
| signature, are required below. If additional signatures are required  |
| in excess of the number of spots below, please obtain and identify th |
| e appropriate signatures on another sheet and attach it to this form. |
+-----------------------------------------------------------------------+

  ----------------------------------- -------- ----------------------------------
                                               **Check all attachments that apply
                                               (see below for \# of copies):**

  Principal Investigator (PI)         Date     
  Signature                                    

                                               Protocol

  Printed Name of PI                           

                                               **X** Protocol Summary

  PI's Dept. Chair's Signature or     Date     
  Dean's Signature if PI is Dept.              
  Chair                                        

                                               **X** Informed Consent/Assent Form
                                               Document(s)

  Printed Name of PI's Dept.                   **X** Personality
  Chair/Dean                                   tests/inventories/questionnaires
                                               (Face Sheet Item #1)

                                               IND Exemption (Face Sheet Item \#
                                               7)

  Co-Investigator's Dept.             Date     
  Chair/Dean's Signature                       

                                               Investigator's brochure/approved
                                               labeling (Face Sheet Item \# 7)

  Printed Name of Co-Investigator's            
  Dept. Chair/Dean                             

                                               **X** Patient Oriented Research
                                               Certificate Modules 1-4 (Face
                                               Sheet Item #10)

  Co-Investigator's Dept.             Date     
  Chair/Dean's Signature                       

                                               Conflict of Interest Disclosure
                                               Form (Face Sheet Item \# 12)

  Printed Name of Co-Investigator's            
  Dept. Chair/Dean                             

                                               Advertisement(s)

  Co-Investigator's Dept.             Date     
  Chair/Dean's Signature                       

                                               Copy of grant application (minus
                                               appendices)

  Printed Name of Co-Investigator's            
  Dept. Chair/Dean                             
  ----------------------------------- -------- ----------------------------------

# REQUIRED MATERIALS TO ACCOMPANY THIS FACE SHEET AND FACE SHEET ATTACHMENTS FOR IRB REVIEW

**[Full-Board Review:]{.underline}**

1 each of the following: Original Signed Cover letter, Original Signed
IRB Face Sheet and any Attachments, Protocol Summary, Informed Consent
Document, Protocol, any Applicable Questionnaires, Diaries, etc., and
applicable investigator drug(s)/device brochure(s) or package inserts
clipped together in this respective order.

3 copies of the IRB Face Sheet and any Attachments, Cover Letter,
Protocol, Protocol Summary, Informed Consent Document, Protocol, any
Applicable Questionnaires, Diaries, etc., and applicable investigator
drug(s)/device brochure(s) or package inserts clipped together in this
respective order.

15 copies of the IRB Face Sheet, Cover Letter, Protocol Summary,
Informed Consent Document, and any Applicable Questionnaires, Diaries,
etc. clipped together in this respective order.

### Expedited Review:

1 each of the following: Original Signed Cover letter, Original Signed
IRB Face Sheet and any Attachments, Protocol Summary, Informed Consent
Document, Protocol, any Applicable Questionnaires, Diaries, etc., and
applicable brochure(s) clipped together in this respective order.