1 of 5 11/6/2014 3:08 PM

Transcription

1 1 of 5 11/6/2014 3:08 PM : Thursday, November 6, :07:42 PM : NU SF: Basic Information 1. * Title of study: Biomedical Research Study 2. * Short title: Biomedical Study 3. * Brief description: This is a brief description of the biomedical study. 4. * Which selection best describes your study? Biomedical 5. * Principal investigator: Debra Tice 6. * Does the Principal Investigator have any significant financial interests related to this research? 7. * Will an external IRB act as the IRB of record for this study? 8. * Attach the protocol: (include the investigator protocol and full sponsor protocol) Category PI Tice Supplement to Sponsor Protocol(11/10 IRB Protocol Biomedical Sponsored Protocol(11/10 IRB Protocol Protocol templates can be found at the following link: : NU SF: Sources of Funding and Other Support (not integrated with Grants) 1. * Identify each organization supporting this research, financially or otherwise: Funding/Support Sponsor's Grants Office s Source Funding ID ID National Institutes of Health R21 HL SP NIH Grant - Sample Biomedical Study

2 2 of 5 11/6/2014 3:08 PM : NU SF: Study Team Members 1. Identify each additional person involved in the design, conduct, or reporting of the research: Name Roles Financial Involved Phone Interest in Lisa Linn Study no yes jhornstein@huronconsultinggroup.com (312) Team Member 2. Identify each additional external person involved in the design, conduct, or reporting of the research: Name Institution Roles Financial Involved Phone Training Interest in John Doe University Co-Investigator no no johndoe@somestate.edu xxx-xxx-xxxx11/6/2014 of Some State : NU SF: Study Scope 1. * Does the study do any of the following: Specify the use of an approved drug or biologic? Use an unapproved drug or biologic? Use a food or dietary supplement to diagnose, cure, treat, or mitigate a disease or condition? Yes No 2. * Does the study do any of the following: Evaluate the safety or effectiveness of a device? Use a humanitarian use device (HUD)? Yes : NU SF: Drugs No 1. * List all drugs, biologics, foods, and dietary supplements to be used in the study: Drug Name Investigational Drug Code Name Name Drug XXX XXXXX Investigator Drug X 2. * Will the study be conducted under any IND numbers? 3. If so, identify each IND: IND Number IND Holder Other Holder Industry Sponsor John Doe Attach files: (such as IND or other information that was not attached for a specific drug) Category

3 3 of 5 11/6/2014 3:08 PM Investigator Brochure Drug X.docx(11/10 Drug Communication from the FDA with Drug the IND number - Drug X.docx(11/10 Package insert Drug X.docx(11/10 Drug : NU SF: s 1. * Select each device the study will evaluate for safety or effectiveness, or each device the submission will use as an HUD: Humanitarian Use Name t Communication from the FDA with the IND Number Product Labeling Drug t.docx 2. * exemptions applicable to this study: IDE 3. If applicable, identify each IDE and HDE number: IDE / HDE Number IDE/ HDE Holder Other Holder Industry Sponsor John Doe 4. Attach files: (such as IDE, HDE, or other information that was not attached for a specific device) Category Communication from the FDA or sponsor with the IDE number(11/10 Sponsor Verification Letter T with IDE number(11/10 Instructions T(11/10 Labeling T(11/10 : NU SF: Recruitment Materials 1. forms: (include an HHS-approved sample consent document, if applicable) Category HRP BIOMEDICAL TEMPLATE CONSENT DOCUMENT.docx(11/10 Form templates can be found at the following link: 2. Recruitment materials: (add all material to be seen or heard by subjects, including ads) Category Radio ad.docx(11/10 Recruitment

4 4 of 5 11/6/2014 3:08 PM Category Materials : NU SF: Sites 1. Please specify study site(s): Northwestern University (NU) Chicago If the research will be conducted at International Sites, Schools (Preschools, Primary Schools, and/or Secondary Schools), or any Other locations, please specify these locations below: Site Contact Phone External IRB Review Rely on Northwestern's IRB There are no items to display : NU SF: Supporting s Select Category to Show: Attach supporting files, naming them as you want them to appear in the approval letter: Radiation Dosimetry Form.docx Created Category 11/6/ /6/2014 Other Suggested attachments: Completed checklist of meeting Department of Energy requirements, if applicable Other study-related documents not attached on previous forms : NU Edit 1. * Funding/Support Organization: National Institutes of Health 2. Sponsor's funding ID: (assigned by external sponsor) R21 HL Grants office ID: (assigned internally) SP Attach files: (include any grant applications) Category NIH Grant - Sample Biomedical Study(11/10 Sponsor : Add External Study Team Member

5 5 of 5 11/6/2014 3:08 PM 1. * First Name: John * Last Name: Doe * Institution: University of Some State Address: johndoe@somestate.edu Telephone Number: xxx-xxx-xxxx 2. * Training : 11/6/2014 Training : 3. * Role in research: (check all that apply) Co-Investigator 4. * Is the team member involved in the consent process? 5. * Does the Co-Investigator have any significant financial interests related to this research? (If this Study Team Member is not a Co-Investigator, answer "No" to this question). : NU Edit 1. * IND number: * Who holds the IND? Industry Sponsor 3. * Identify the IND holder: John Doe