ࡱ> XZUVW!` ^bjbj\\ 4R>>'|||||||nnn8nL:pƞ sd n|(||||L< $h`||||||||||||||r z}Vnǎ:} 0ƞ||||l:hTƞd5RTdRT4"|||||| fox COMMERICAL INSTITUTIONAL REVIEW BOARD, LTD. 326 North Seventh St. " Suite 218 " Springfield, IL 62701 Office (217) 492-1369 " Fax (217) 492-9369 Site Questionnaire A. PRINCIPAL INVESTIGATOR (Include curriculum vitae for the principal investigation, and sub-investigator(s) and a copy of the current medical/professional license or certificate for each, if applicable) Name of Principal Investigator: FORMTEXT   FORMCHECKBOX  M FORMCHECKBOX  FName of Site*: FORMTEXT      Street: FORMTEXT      City: FORMTEXT      State: FORMTEXT  ZIP: FORMTEXT      Phone: FORMTEXT      Fax: FORMTEXT      E-mail: FORMTEXT       Name of Study Coordinator:  FORMTEXT      Street: FORMTEXT      City: FORMTEXT      State: FORMTEXT   ZIP: FORMTEXT      Phone: FORMTEXT      Fax: FORMTEXT      E-mail: FORMTEXT       Name of Coordinating Group:  FORMTEXT      Contact Name: FORMTEXT      Street: FORMTEXT      City: FORMTEXT      State: FORMTEXT   ZIP: FORMTEXT      Phone: FORMTEXT      Fax: FORMTEXT      E-mail: FORMTEXT      * Please attach contact names and addresses for additional sites. Medical License Information, if applicableLicense Number: FORMTEXT      State: FORMTEXT   Expiration: FORMTEXT      DEA Number: FORMTEXT      Expiration: FORMTEXT      Massachusetts Investigators: Res. Reg. Number: FORMTEXT      Expiration: FORMTEXT       FORMCHECKBOX  YES FORMCHECKBOX  NOHas your license to practice medicine ever been suspended, revoked or restricted? FORMCHECKBOX  YES FORMCHECKBOX  NOHave you ever had your hospital privileges suspended, revoked or restricted? FORMCHECKBOX  YES FORMCHECKBOX  NOHave you or any of your sub-investigators ever been under sanction by any state medical board?If yes to any of the above three questions, then please explain on a separate sheet.  FORMCHECKBOX  YES FORMCHECKBOX  NOAre you board certified? If yes, list certification and dates:  FORMTEXT       Professional License / Certification Information, if applicableLicense/Certification Number: FORMTEXT      State: FORMTEXT   Expiration: FORMTEXT      Profession: FORMTEXT       FORMCHECKBOX  YES FORMCHECKBOX  NOHas your license/Certificate ever been suspended, revoked or restricted?If yes, please describe:  FORMTEXT       Research Experience How long have you been conducting human research? FORMTEXT        FORMCHECKBOX  YES FORMCHECKBOX  NOHave you been a Principal Investigator in the last five years? FORMCHECKBOX  YES FORMCHECKBOX  NO FORMCHECKBOX  NAHave you ever been audited by the FDA? (Attach the Form 483 or letter, if any) FORMCHECKBOX  YES FORMCHECKBOX  NOHas any IRB disapproved or terminated any of your studies? FORMCHECKBOX  YES FORMCHECKBOX  NOHave you had any training in protecting the rights and welfare of human subjects within the past year? Please provide documentation. Conflict of Interest (All possible conflicts of interest should be revealed.)  FORMCHECKBOX  YES FORMCHECKBOX  NODo you have any equity position with any potential sponsor or competitor? FORMCHECKBOX  YES FORMCHECKBOX  NODo you have any patent positions? FORMCHECKBOX  YES FORMCHECKBOX  NOAre you usually compensated for your participation? If yes, in what form? FORMCHECKBOX  Non Monetary FORMCHECKBOX  Monetary FORMCHECKBOX  Per subject enrolled FORMCHECKBOX  Per subject completed FORMCHECKBOX  Per project FORMCHECKBOX  YES FORMCHECKBOX  NOAre there ever enrollment or completion bonuses for you or your staff? If yes, then please explain on a separate sheet. FORMCHECKBOX  YES FORMCHECKBOX  NODo you participate in protocol development or drug/device development for studies in which you participate? B. SITE (Attach a brochure, if available)  FORMCHECKBOX  Not-for-profit business/organization FORMCHECKBOX  For-profit business/organization FORMCHECKBOX  Military FORMCHECKBOX  Hospital FORMCHECKBOX  University FORMCHECKBOX Clinic connected to hospital FORMCHECKBOX  Free-standing clinic FORMCHECKBOX  Private Practice (specialty  FORMTEXT      ) FORMCHECKBOX  YES FORMCHECKBOX  NOIs there an institutional based IRB which you are required to use? FORMCHECKBOX  YES FORMCHECKBOX  NO FORMCHECKBOX  NAIf so, has this IRB been asked to provide a letter of waiver to Fox Commercial IRB? Emergency Information How close is your site to a hospital with emergency facilities? FORMTEXT      Name of Hospital: FORMTEXT      Describe what emergency facilities are available for a subject on site (i.e., crash cart, etc.): FORMTEXT      List the emergency phone number for subjects to use in case of questions or emergency: FORMTEXT       FORMCHECKBOX  YES FORMCHECKBOX  NOIs someone available on 24 hour call? FORMCHECKBOX  YES FORMCHECKBOX  NO FORMCHECKBOX  NAAre subjects given emergency bracelets, cards, notices, etc.? FORMCHECKBOX  YES FORMCHECKBOX  NO FORMCHECKBOX  NAIs there usually a drug abstract available in case of an emergency? Community Attitude  FORMCHECKBOX  YES FORMCHECKBOX  NOAre there any state or local laws governing human subject participation or the types of studies that can be conducted? If these are contrary to federal regulations, please attach. FORMCHECKBOX  YES FORMCHECKBOX  NOAre there any community religious, ethical, ethnic, or economic attitudes which will affect the conduct of research at your site? If yes, describe in detail on a separate page. C. SUBJECT RECRUITMENT Do you generally draw your subjects from any of the following groups? FORMCHECKBOX  YES FORMCHECKBOX  NOMinors FORMCHECKBOX  YES FORMCHECKBOX  NONon-English Speaking FORMCHECKBOX  YES FORMCHECKBOX  NOPrisoners FORMCHECKBOX  YES FORMCHECKBOX  NOEconomically Disadvantaged FORMCHECKBOX  YES FORMCHECKBOX  NOPregnant Women FORMCHECKBOX  YES FORMCHECKBOX  NOEducationally Disadvantaged FORMCHECKBOX  YES FORMCHECKBOX  NOMentally Disabled FORMCHECKBOX  YES FORMCHECKBOX  NOLife-Threatening Condition FORMCHECKBOX  YES FORMCHECKBOX  NOPhysically Disabled FORMCHECKBOX  YES FORMCHECKBOX  NOSeriously Debilitating Illness or DiseaseIf non-English speaking, then name the primary language: FORMTEXT       Do you generally recruit subjects for research through the following means? 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INFORMED CONSENT  FORMCHECKBOX  YES FORMCHECKBOX  NODo you ever conduct studies that enroll pediatric subjects? FORMCHECKBOX  YES FORMCHECKBOX  NOIf yes, do you believe written assent from children 6 years or older is necessary? FORMCHECKBOX  YES FORMCHECKBOX  NODo you, as the investigator, discuss the consent with potential study subjects? If not, then who does? FORMTEXT      Please indicate this persons degree and level of training that qualifies him to discuss the consent: FORMTEXT      How long does the subject usually have between first seeing the consent form and being asked to sign it? FORMTEXT      How do you assess comprehension? FORMTEXT       FORMCHECKBOX  YES FORMCHECKBOX  NO FORMCHECKBOX  NAWhen you enroll non-English speaking subjects, do you use a translated consent form? (If yes, what primary language?  FORMTEXT      ) FORMCHECKBOX  YES FORMCHECKBOX  NODo you have someone at your site who is capable of answering questions for non-English speaking subjects in their language and who is available during the study? FORMCHECKBOX  YES FORMCHECKBOX  NO FORMCHECKBOX  NAIf laboratory tests include an HIV screen or an AIDS test does your state law require that subjects be provided with a separate HIV consent before performing the test? If yes, provide a sample. E. COMPENSATION FOR INJURY  FORMCHECKBOX  YES FORMCHECKBOX  NOHave you ever had any subjects seek compensation for injury as a result of their participation in a research study? FORMCHECKBOX  YES FORMCHECKBOX  NOIf yes, were there any problems in resolving it? Please explain on a separate sheet. F. CONFIDENTIALITY AND PRIVACY  FORMCHECKBOX  YES FORMCHECKBOX  NO FORMCHECKBOX  NAIs the subject s research record stored separately from their patient or medical record? FORMCHECKBOX  YES FORMCHECKBOX  NOIs the consent form stored separately from the research records? FORMCHECKBOX  YES FORMCHECKBOX  NOAre research data forms coded to protect privacy? (Social Security Numbers are not acceptable) If yes, where is the key to the code stored?  FORMTEXT      If no, describe your method of protecting identities: FORMTEXT       G. ASSURANCE As Principal Investigator, I am responsible for the conduct of this study, including the conduct of my sub-investigators and staff during this study. I certify that the information in this document is correct. I will follow the protocol or I will notify the IRB of my deviations from protocol. I or my designee will obtain informed consent from each subject on the approved informal consent document, allowing each person time to consider the questions. I will notify the IRB of every serious or unusual or unanticipated adverse event. I will inform the IRB of the result of any investigator audit, and I will protect the rights and welfare of each subject to the best of my ability. INVESTIGATOR S SIGNATURE: FORMTEXT       DATE: FORMTEXT           2006 Fox Commercial Institutional Review Board, Ltd.  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