Initial Review Submission Form

WIRB® WESTERN INSTITUTIONAL REVIEW BOARD® WESTERN INTERNATIONAL REVIEW BOARD® 3535 SEVENTH AVE SW • OLYMPIA, WA 98502-5010 P.O. BOX 12029 • OLYMPIA, WA 98508-2029 (360) 252-2500 • 1-800-562-4789 • Fax (360) 252-2498 www.wirb.com • [email protected]

WIRB INITIAL REVIEW SUBMISSION REQUIREMENTS

The following is a general list of items needed by WIRB to begin the review process for your research study. You will need to submit the Initial Review Submission Form once for each initial review submission. If you have questions, call 1-800-562-4789 or e-mail [email protected] for -assistance. ALL INITIAL REVIEW REQUESTS must include copies of the following:

 WIRB Initial Review Submission Form (See attached; this blank form may be duplicated for use in future study submissions. It may also be downloaded from www.wirb.com.)  Protocol (If previously received by WIRB, you may submit the protocol title page and signature page only.)  Current professional license for Principal Investigator, showing the expiration date. (You do not need to send a copy of the license if WIRB has a current copy on file.)  Curriculum Vitae (CV) for Principal Investigator and each Sub-Investigator (if not submitted to WIRB within the past year)  Consent form (see section IV in Submission Form for details) For multicenter studies, a previously approved WIRB consent form for this protocol may be available. You will be asked on the attached form if you would like to use it.

If a DRUG/BIOLOGIC study, a copy of the following:  Investigator’s Drug Brochure (You do not need to send copy if WIRB has a current copy on file.) If the brochure is a revised or amended version, include a summary of the changes (if available).  Background Information for Food Supplements  FDA Form 1572 (if applicable)  Canadian Research Ethics Board Attestation Form (Canadian sites)  A request for WIRB Institutional Biosafety Committee (IBC) review or the IBC approval information from the review of your study. (Gene Transfer Protocols)

If a DEVICE study, a copy of the signed Investigator Agreement for protocols with an IDE, and ONE of the following:  FDA Letter granting the Investigational Device Exemption (IDE); OR  Letter from sponsor stating that the study is a non-significant risk device study; OR  Letter explaining why the investigation is exempt from the IDE requirements under 21CFR 812.2(c) or otherwise exempt.

If you would like to request review of a change in research or subject recruitment material for research that is currently under WIRB oversight, please submit your requests using the Changes in Research Submission Form or Subject Recruitment Submission Form. These forms are available on our web site (www.wirb.com) or can be requested from Client Services by calling 1-800-562-4789 or e-mailing [email protected].

Initial Review Submission Form, Revised 01-2002 041599001 Supersedes previous versions WIRB® WESTERN INSTITUTIONAL REVIEW BOARD® WESTERN INTERNATIONAL REVIEW BOARD® 3535 SEVENTH AVE SW • OLYMPIA, WA 98502-5010 P.O. BOX 12029 • OLYMPIA, WA 98508-2029 (360) 252-2500 • 1-800-562-4789 • Fax (360) 252-2498 www.wirb.com • [email protected] Initial Review Submission Form Sponsor Otsuka America Pharmaceutical. Inc. Sponsor Protocol No. 21-01-334 I. PRINCIPAL INVESTIGATOR (PI) INFORMATION: Please provide information about the person legally responsible for the conduct of the research. WIRB must be assured that the investigator can personally oversee the conduct of the research and the protection of human subjects. [21 CFR 56.102 (h)]

1. PI Name:

1a. PI Company Name:

1b. PI Mailing Address: (street, city, state/province, zip, country)

1c. PI Phone: PI Fax: PI E-mail: ( ) ( ) 1d. How would the PI prefer to receive study documents? (check one) Fax E-mail Regular Mail 1e. PI Degree(s): PI Specialty(ies):

2. Study Coordinator Name:

2a. Study Coordinator Phone: Study Coordinator Fax: Study Coordinator E-mail: ( ) ( ) 3. Has the PI ever received an FDA Warning Letter that has not been previously submitted to WIRB? Yes No 4. Has the PI ever been convicted of a crime, disciplined by a public or private medical organization, *Yes No disciplined by a licensing authority or is the PI currently involved in such a proceeding? *If Yes, please attach explanation 5. Licensing Information: Please fill in the information requested below and attach legible copies of all pertinent current licenses and registrations (if not on file at WIRB). If necessary, please enlarge the copy of the licenses for legibility. 5a. Medical License #: N/A State/province: Expiration Date: 5b. DEA Registration # (if applicable): N/A Expiration Date: 5c. If this PI will conduct research involving an investigational drug in the state of Massachusetts, provide the PI’s N/A Massachusetts Research Registration number: 6. Please attach a signed copy of each of the following (if applicable): N/A  U.S. FDA form 1572,  Canadian Research Ethics Board Attestation Form;  Your country’s equivalent.

Initial Review Submission Form, Revised 01-2002 1 of 9 041599001 Supersedes previous versions Initial Review Submission Form WIRB®

Sponsor Protocol # 21-01-334 Investigator Last Name:

7. Does the PI, PI’s family, the study staff, or the study staff’s family have any financial relationship with the *Yes No sponsor other than payment for the conduct of clinical research? *If Yes, please describe the relationship on a separate sheet of paper. (Examples include speaking fees, consultation fees, stock ownership or other equity interest, patents, trademarks, copyrights, licensing agreements.) Report interests valuing over $10,000 and interests representing a greater than 5% ownership in an enterprise.

8. For this protocol, how many of the following will the PI supervise? Physician Sub-Investigators Sites

9. How many of the following does the PI currently supervise? (total) Open Research Studies Locations Physician Sub-Investigators Research Staff Approx. Number of active subjects

10. Will a Site Management Organization (SMO) be involved in this research? If No, proceed to question 11. Yes No

10a. SMO Name:

10b. SMO Address: (street, city, state/province, zip, country)

10c. SMO Contact Name:

10d. SMO Contact Phone: SMO Contact Fax: SMO Contact E-mail: ( ) ( ) 10e. How would the SMO contact prefer to receive documents from WIRB? (check one) Fax E-mail Regular Mail

II. SPONSOR & PROTOCOL INFORMATION: Please tell us about the research to be conducted.

11. Protocol Number and Version Date: 21-01-334 12/04/01 12. Is this research investigator-initiated? (e.g., no separate sponsor is involved) If Yes, proceed to question 14. Yes No

13. Sponsor Name: Otsuka America Pharmaceutical, Inc. 13b. Sponsor Contact Name: Mary Dolan 13c. Sponsor Contact Address: (street, city, state/province, zip, country) 2440 Research Boulevard Rockville, MD 20850

13d. Sponsor Contact Phone: Sponsor Contact Fax: Sponsor Contact E-mail: (240) 683-3239 (301) 721-7193 [email protected] 13e. How would the sponsor contact prefer to receive documents from WIRB? (check one) Fax E-mail Regular Mail

13f. Medical Monitor Name: Trinh Ly 13g. Medical Monitor Phone: Medical Monitor Fax: Medical Monitor E-mail: (240) 638-3193 (301) 721-7193 [email protected]

14. Is a Contract Research Organization (CRO) involved in this research? If No, proceed to question 15. Yes No

14a. CRO Name: Emory Center for Outcomes Research (ECOR)

14b. CRO Address: (street, city, state/province, zip, country) 1256 Briarcliff Road, Suite 1 North Atlanta, GA 30306

14c. CRO Contact Name: Felicia Warren 14d. CRO Contact Phone: CRO Contact Fax: CRO Contact E-mail: (404) 727-3683 (404) 727-6495 [email protected] 14e. How would the CRO contact prefer to receive documents from WIRB? (check one) Fax E-mail Regular Mail

15. Please list each item for which the PI is seeking Board review and approval: (e.g., patient diaries, amendments, consent form addenda, ads) Protocol WIRB: 20011871 (previously approved) Consent WIRB: 20011871 (previously approved)

16. Has this research study been disapproved or terminated by another IRB prior to submission to WIRB? *Yes No *If Yes, please provide the IRB disapproval or termination letter.

17. Is this research federally funded entirely or in part? If No, proceed to question 18. Yes No

17a. What federal agency(ies) is funding this research? N/A

17b. Provide a copy of the complete grant (if applicable). N/A 17c. Provide the federal contract (if applicable). N/A 18. Is this a behavioral research protocol? Yes No

19. Does this research involve an Investigational New Drug or Biologic? If No, proceed to question 20. Yes No

19a. Provide the Investigational New Drug (IND) number assigned by the FDA: N/A

19b. If an IND number is not available, please attach an explanation of why an IND was not obtained. N/A

19c. Provide a copy of the Investigator’s Drug Brochure (unless previously sent to WIRB), applicable package N/A inserts, or the background information for food supplements.

20. Does this research involve an Investigational Device? If No, proceed to question 21. Yes No

20a. Provide one of the following: N/A  FDA letter granting an Investigational Device Exemption for the proposed use,  Letter from sponsor stating that the study is a non-significant risk device study, or  Letter explaining why the investigation is exempt from the IDE requirements under 21CFR 812.2(c) or otherwise exempt.

Sponsor Protocol # 21-01-334 Investigator Last Name: 21. Does this research involve any form of Gene Transfer? If No, proceed to question 22. Yes No

21a. Has this been submitted to the Recombinant DNA Advisory Committee (RAC)? Yes No

21b. If available, attach the Response to Appendix M of the National Institutes of Health (NIH) Guidelines. N/A 21c. If available, attach copies of the RAC correspondence regarding the protocol. N/A 21d. Has there been an Institutional Biosafety Committee (IBC) review? *Yes No *If Yes, please attach the IBC recommendations. IBC services are available through WIRB. Contact IBC Services at (360) 252-2850 for fee schedule and IBC submission form. III. RESEARCH SITE LOCATIONS & INFORMATION (must match 1572, if applicable): Please tell us where the research will take place by completing this section for each site. If you will be conducting the research at more than two sites, please make additional copies of this page to list the additional sites. 22. Site #1: If Site #1 is the same as the mailing address listed above in the PI section (section I), write “same” below and proceed to question 22b. Name of Research Location: Address: (street, city, state/province, zip, country)

22a. Site #1 Phone: Site #1 Fax: Site #1 E-mail: ( ) ( ) 22b. What type of facility is this site? Medical office Hospital University Psychiatric Institution Nursing home Other (specify):

22c. Is equipment available at this research location to treat life-threatening adverse reactions? Yes No

22d. Medical facility to be used in an emergency: N/A 22e. Does the PI have staff privileges at this facility? Yes No

23. Site #2: N/A Name of Research Location: Address: (street, city, state/province, zip, country)

23a. Site #2 Phone: Site #2 Fax: Site #2 E-mail: ( ) ( ) 23b. What type of facility is this site? Medical office Hospital University Psychiatric Institution Nursing home Other (specify):

23c. Is equipment available at this research location to treat life-threatening adverse reactions? Yes No

23d. Medical facility to be used in an emergency: N/A

23e. Does the PI have staff privileges at this facility? Yes No

24. Please make a copy of this page to list additional sites. N/A

25. Does the PI have an obligation to use another IRB for any site in this study? *Yes No *If Yes, WIRB will need a written statement from the other IRB acknowledging WIRB’s review of this research. Please call Client Services for more information. 26. Describe any local attitude toward medical research that might affect this study: Positive Negative If other than positive, please explain:

27. Will this research enroll any subjects from the following “vulnerable” categories? *Yes No *If Yes, please list all vulnerable subject groups, even those clearly identified in the protocol inclusion criteria. Mentally ill Mentally disabled Nursing home residents Institutionalized Chronic condition Terminally ill Hospitalized Pregnant women Limited or non-readers Poor/uninsured Children Prisoners Students of PI or study staff Students to be recruited in their educational setting , i.e. in class or at school. Employees of Research Site, PI or Sponsor Military personnel to be recruited by military personnel Others Vulnerable to Coercion (Specify)

28. Are there laws governing medical research in your state/province? If No, proceed to question 29. Yes No un- known

28a. Have the laws governing research in your state/province changed in the past year? Yes No un- known

29. Will the research use any direct identifiers? (e.g., names; Social Security numbers; patient, hospital, *Yes No laboratory or claim numbers; addresses; telephone numbers; locator information) *If yes, explain how confidentiality of this information will be protected.

30. Will the research use indirect identifiers (e.g., study code numbers, pseudonyms, initials) which could be *Yes No linked to direct identifiers? *If yes, explain how confidentiality of this information will be protected. Case report forms will include patient initials and a study number based on a randomization scheme that will not be available to PI or Sudy Coordinator.

31. Will any personnel not directly related to the research have access to identifiable data or samples? *Yes No *If yes, explain how confidentiality of this information will be protected.

32. How long will the research data be stored by the PI? 2 years years after close of study

33. Please describe the roles of those members of the study team who are involved in the consent process. Name/Site(s) Title Role Example: Provide medical oversight for study subjects. Responsible for John Doe, M.D., Sites #1 & #2 PI all study related issues.

Attach an additional page, if necessary.

IV. RECRUITMENT, CONSENT & SUBJECT PAYMENT INFORMATION: Please provide information about how subjects will be recruited, the consent form subjects will be asked to sign, and what type of payment subjects will receive.

34. Check any of the following methods that the PI will use to recruit subjects for this study: From Personal Contact (e.g., patients, students) Referrals (referral fees are not allowed by WIRB) From a database other than the PI’s personal contacts. Please describe the type of database (e.g., disease registry, CRO/SMO database), the protections for subject confidentiality, and the method by which subjects will be contacted:

Advertising (All recruitment materials must be approved by WIRB before use) Other (specify):

35. Are recruitment materials attached? *Yes No *If yes, check all that are attached: Newspaper Letter Posting Brochure Web Site Public Service Announcement TV (script; tape) Radio (script; tape) Other

35a. Have any of these recruitment materials been previously approved by WIRB? *Yes No *If yes, please attach a copy of the previously-approved item(s). 35b. Are you submitting any recruitment materials that reference a web site? Yes No

36. Who will perform the screening examination of the patients to determine if they are eligible for the research? (if N/A applicable)

37. Does the PI plan to recruit cognitively impaired subjects? If No, proceed to question 38. Yes No

37a. If some or all subjects will be cognitively impaired, describe how capacity for consent will be determined: N/A Capacity Assessment by (e.g., MMSE, independent physician, etc.) Other (specify):

38. Approximate ethnic makeup of population to be recruited for this research: If your site is in North America: % African-American % Asian % Pacific Islander % Middle Eastern % Caucasian % Hispanic % Native American/First Nations % Other:

If your site is in Latin America: Composición étnica aproximada de la población que será reclutada en este estudio: % blanco % indígena % mestizo % mulato % medio oriente % asiático % negro % otro (especificar)

If your site is not in the Americas: Please indicate percentages of applicable ethnic populations.

41. Please indicate the language(s) of the subjects the PI plans to enroll. The consent form must be in a language easily understood by the subject, and all consent form translations must be approved by WIRB. English Spanish Other

42. Would you like WIRB to provide translation(s) of the approved consent form? (extra fee) *Yes No *If yes, list the languages requested: If you will provide the translation(s), contact the WIRB translations department for requirements.

43. For multicenter studies, a previously approved WIRB consent form for this protocol may be available. If Yes No available, would you like to use it? If Yes, proceed to question 42.

41a. If you prefer not to use the previously approved WIRB consent form for this protocol or this is not a multicenter N/A study, indicate your consent form preference by checking one of the following: Use enclosed (if on disk, Microsoft Word compatible). If you are using a sponsor’s template consent form, please highlight any changes you have made. Request WIRB write consent form (extra fee)

44. Contact information to be listed in the Consent Form: N/A Contact name and phone number for questions about the study:

Name Phone number(s): ( ) Office Hours 24 hours Pager (check all that apply) ( ) Office Hours 24 hours Pager (check all that apply)

Contact name and phone number for use in the event of research-related injury: Name Phone number(s): ( ) Office Hours 24 hours Pager (check all that apply) ( ) Office Hours 24 hours Pager (check all that apply)

45. Please provide subject payment information: N/A

Subjects will not be paid. Subjects will be reimbursed for travel and or parking as follows:

Subjects will be paid according to attached payment schedule or as stated in submitted consent form. OR  Subjects will be paid as follows:

Amount per completed visit: $

Number of visits in this study:

List any visits not paid: Total, or Do not list a total in the consent form $

For your convenience, a summary of attachments requested within this form is provided below. Check all that are attached. Explanation of criminal or medical organization proceeding against the PI (question 4) Medical license(s) (question 5) U.S. FDA form 1572, Canadian Research Ethics Board Attestation Form(s) or your country’s equivalent (question 6) Description of financial relationship with the sponsor (question 7) Documents submitted for Board approval (question 15) IRB disapproval or termination letter (question 16) Grant (question 17b) Federal contract (question 17c) Explanation of why an IND number was not obtained (question 19b) Investigator’s Drug Brochure, applicable package insert(s), or background information on food supplements (question 19c) Device-related documentation (question 20a ) Response to Appendix M of the NIH guidelines (question 21b) Copies of the RAC correspondence regarding this protocol (question 21c) Institutional Biosafety Committee recommendations (question 21d) Additional sites (question 24) Names and roles of additional study team members (question 33) Recruitment materials (question 35) Recruitment materials previously approved by WIRB (question 35a) Payment schedule (question 43)

V. BILLING INFORMATION: Please tell us who should be billed for this review. (If this section is not completed, the PI will be billed)

46. Company Name: Emory Center for Outcomes Research (ECOR) 44a. Attn.: Claudine Jurkovitz, MD, MPH 44b. Address: (street, city, state/province, zip, country) 1256 Briarcliff Road, Suite 1 North Atlanta, GA 30306

44c. Phone: Fax: E-mail: (404) 712-9983 (404) 727-6495 [email protected] 44d. Mail Stop/Cost Center:

44e. Purchase Order number (P.O.#), if applicable:

44f. Cost of the requested WIRB translation services will be paid by: (if applicable)

44g. Please describe any special billing instructions: Send invoice with detailed description of services provided by WIRB VI. NAME OF PERSON COMPLETING THIS FORM: Please tell us who you are and how we can contact you if we have questions about this form.

Printed or Typed Name of Person Completing This Form Company & title

______Signature Date

( ) ( ) Phone number Fax number

Initial Review Submission Form, Revised 01-2002 9 of 9 041599001 Supersedes previous versions