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					Clinical Research

Study Implementation at
Children’s Memorial Hospital

Ashley Brummel, Clinical Research Coordinator
Agenda
■ Site Information and CDA Process
■ Review Potential Patients
■ Regulatory
    ■ 1572
    ■ CVs and License Record
    ■ Financial Disclosures
    ■ Delegation of responsibilities
■ Study Budget and Negotiation
    ■ Letters of Support
■ Contract (OSP)
■ IRB Submission and OSP Routing Form
    ■ Research Plan
    ■ Consent and Assent Modification

                                        2
Confidential Disclosure Agreement

Example




                                    3
CDA Signatures




                 4
                                      Principal Investigator Information Sheet (PI Info Sheet)

                Thank you for your interest in a clinical study with Serious Pharmaceuticals. So that we may
                efficiently process your agreement and to make certain that your payments are routed
                correctly, kindly complete this information form in regard to the Clinical Study listed below.

Site                               Please send the completed form to the following person
                Name: Christine Mullen
                phone:                         Fax:                         e-mail:
Information      If you have any questions, please contact the person listed above
                 Your promptness in responding will help us to avoid any delays in processing your
                   agreement and payments. Thank you.
Questionnaire                                               Clinical Study
                Drug Name:                                               Protocol Number: 1111111
                Protocol Title:   A multi-center, international, open-label study to compare

                                                       Principal Investigator
                Name:         Geoffrey Allen, MD
                Address:      Children’s Memorial Hospital
                              2300 Children’s Plaza, #30
                              Lincoln and Fullerton
                              Chicago, IL 60614

                Telephone:                                        Fax:
                Email:      GAllen@childrensmemorial.org
                Employer Name (if any):     Children’s Memorial Hospital
                Employer Business Address:
                                            Children’s Memorial Hospital
                                            2300 Children’s Plaza, #30
                                            Lincoln and Fullerton
                                            Chicago, IL 60614

                If Principal Investigator is not an          N/A
                employee, is Principal Investigator a
                Contractor, Sole Proprietor or Partner?

                                                  Employer contacts
                Budget contact name and title: Harmony Maple
                Telephone: (773) 755-6334                      Fax:             (773) 755-6533
                Email:      hmaple@childrensmemorial.org

                Contract contact name and title: Harmony Maple
                Telephone: (773) 755-6334                              Fax:     (773) 755-6533
                Email:       hmaple@childrensmemorial.org
                                                                                                                 5
Eligible Patients
    Review Protocol for Inclusion/Exclusion Criteria
    Review Database for Eligible Patients
    Prepare Working List
    Review List with Staff

                                                           Next Clinic     Consent
    CMH #   Name              DOB       Age   Dx    Dr
                                                              Visit         Date
                                                                                     2/17/2008
1   200001 Flinstone, Fred   10/15/91   16    SS   Smith     2/19/08
2   300001 Brown, Charlie    2/26/98    9     SS            ------------   7/17/07

3   400001 Explorer, Dora    9/13/86    21    SC
4   100001 Doo, Scooby       6/28/03    4     SS   Smith     3/24/08
5   500001 Simpson, Bart     6/26/90    17    SS            ------------    5/1/07



                                                                                         6
7
The 1572                 DEPARTMENT OF HEALTH AND HUMAN SERVICES
                                    FOOD AND DRUG ADMINISTRATION

                                STATEMENT OF INVESTIGATOR
                   (TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312)
                                                                                                    Form Approved: OMB No. 0910-0014.
                                                                                                    Expiration Date: May 31, 2009.
                                                                                                    See OMB Statement on Reverse.

                                                                                                    NOTE: No investigator may participate in an
                                                                                                    investigation until he/she provides the sponsor with
                                  (See instructions on reverse side.)                               a completed, signed Statement of Investigator,
                                                                                                    Form FDA 1572 (21 CFR 312.53(c)).
           1. NAME AND ADDRESS OF INVESTIGATOR

              Geoffrey Allen, MD
              Hematology/Oncology Transplantation
              Children's Memorial Hospital
              2300 Children’s Plaza, Box #30
              Chicago, IL 60614
           2. EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFIES THE INVESTIGATOR AS AN EXPERT IN THE CLINICAL INVESTIGATION OF THE
              DRUG FOR THE USE UNDER INVESTIGATION. ONE OF THE FOLLOWING IS ATTACHED.

                                               CURRICULUM VITAE            OTHER STATEMENT OF QUALIFICATIONS


           3. NAME AND ADDRESS OF ANY MEDICAL SCHOOL, HOSPITAL OR OTHER RESEARCH FACILITY WHERE THE CLINICAL INVESTIGATION(S) WILL
              BE CONDUCTED.

              Children's Memorial Hospital
              2300 Children’s Plaza
              Chicago, IL 60614



           4. NAME AND ADDRESS OF ANY CLINICAL LABORATORY FACILITIES TO BE USED IN THE STUDY.

              Children's Memorial Hospital                      Quest Diagnostics Clinical Trials
              Department of Pathology                           7600 Tyrone Avenue
              2300 Children's Plaza                             Van Nuys, CA 91405
              Chicago, IL 60614


           5. NAME AND ADDRESS OF THE INSTITUTIONAL REVIEW BOARD (IRB) THAT IS RESPONSIBLE FOR REVIEW AND APPROVAL OF THE STUDY(IES).

              Children's Memorial Hospital
              2300 Children’s Plaza, Box 205
              Chicago, IL 60614



           6. NAMES OF THE SUBINVESTIGATORS (e.g., research fellows, residents, associates) WHO WILL BE ASSISTING THE INVESTIGATOR IN THE
              CONDUCT OF THE INVESTIGATION(S).

              Geoffrey Allen, MD               Ashley Brummel, BA                          Denise Rizzo, PharmD
              Robert Liem, MD                  Leticia Valdiviez, PNP                      Jamie Sovcik, PharmD
              Alexis Thompson, MD              Susan Gamerman, RN
              Kyle Mack, MD

           7. NAME AND CODE NUMBER, IF ANY, OF THE PROTOCOL(S) IN THE IND FOR THE STUDY(IES) TO BE CONDUCTED BY THE INVESTIGATOR.

              A Multi-center, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimes of Recombinant
              Coagulation Factor      Reformulated Drug Product in Subjects With Severe Hemophilia



                                                                                                                                                           8
8. ATTACH THE FOLLOWING CLINICAL PROTOCOL INFORMATION:

         FOR PHASE 1 INVESTIGATIONS, A GENERAL OUTLINE OF THE PLANNED INVESTIGATION INCLUDING THE ESTIMATED DURATION OF
         THE STUDY AND THE MAXIMUM NUMBER OF SUBJECTS THAT WILL BE INVOLVED.

         FOR PHASE 2 OR 3 INVESTIGATIONS, AN OUTLINE OF THE STUDY PROTOCOL INCLUDING AN APPROXIMATION OF THE NUMBER OF
         SUBJECTS TO BE TREATED WITH THE DRUG AND THE NUMBER TO BE EMPLOYED AS CONTROLS, IF ANY; THE CLINICAL USES TO BE
         INVESTIGATED; CHARACTERISTICS OF SUBJECTS BY AGE, SEX, AND CONDITION; THE KIND OF CLINICAL OBSERVATIONS AND
         LABORATORY TESTS TO BE CONDUCTED; THE ESTIMATED DURATION OF THE STUDY; AND COPIES OR A DESCRIPTION OF CASE
         REPORT FORMS TO BE USED.

9. COMMITMENTS:

     I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying
     the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.

     I agree to personally conduct or supervise the described investigation(s).

     I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure
     that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review and approval in 21
     CFR Part 56 are met.

     I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64.

     I have read and understand the information in the investigator’s brochure, including the potential risks and side effects of the drug.

     I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligatio ns
     in meeting the above commitments.

     I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make those records available for inspection in
     accordance with 21 CFR 312.68.

     I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review and
     approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated
     problems involving risks to human subjects or others. Additionally, I will not make any changes in the research without IRB approval, except
     where necessary to eliminate apparent immediate hazards to human subjects.

     I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR
     Part 312.



                                              INSTRUCTIONS FOR COMPLETING FORM FDA 1572
                                                     STATEMENT OF INVESTIGATOR:

     1. Complete all sections. Attach a separate page if additional space is needed.

     2. Attach curriculum vitae or other statement of qualifications as described in Section 2.

     3. Attach protocol outline as described in Section 8.

     4. Sign and date below.

     5. FORWARD THE COMPLETED FORM AND ATTACHMENTS TO THE SPONSOR. The sponsor will incorporate
        this information along with other technical data into an Investigational New Drug Application (IND).

10. SIGNATURE OF INVESTIGATOR                                                                                                  11. DATE



(WARNING: A willfully false statement is a criminal offense. U.S.C. Title 18, Sec. 1001.)

Public reporting burden for this collection of information is estimated to average 100 hours per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Food and Drug Administration                            Food and Drug Administration                            "An agency may not conduct or sponsor, and a
CBER (HFM-99)                                           CDER (HFD-94)                                           person is not required to respond to, a
1401 Rockville Pike                                     12229 Wilkins Avenue                                    collection of information unless it displays a
Rockville, MD 20852-1448                                Rockville, MD 20852                                     currently valid OMB control number."
                                                                                                                                                                 9
                                                    Please DO NOT RETURN this application to this address.
           DISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS

Drug Name or Number:

Protocol Number:

Protocol Title: Dose Escalation Study:                   Infusion [0000] for the Prevention of Acute Chest Syndrome in At-Risk Patients with Sickle Cell
Disease and Vaso-occlusive Crisis

Investigator Name:

Site/Institution Name: _________________________________

Serious Pharmaceuticals, Inc. requests that as an Investigator for the above listed study, you provide the required financial disclosure information. You
must update this form if any relevant changes in financial information occur in the course of the study or for 1 year following completion of the study.

As a clinical investigator listed on the Form FDA 1572, have you or any member of your immediate family (spouse and/or dependent children) ever:

 NO     YES     1) Entered into any financial arrangement with Serious whereby the value of
 [ ]    [ ]        compensation for conducting the Clinical Trial could be affected by the outcome of
                   the Clinical Trial (e.g., compensation tied to sales or royalty interest)?
 NO     YES     2) Owned or entered into an agreement to own a significant equity interest in Serious
 [ ]    [ ]        (e.g., ownership interest, stock options or stock) that exceeds $50,000.00 in value?

 NO     YES     3) Owned or entered into an agreement to own a proprietary interest in the Serious
 [ ]    [ ]        product which is the subject of the Clinical Trial, including but not limited to patent,
                   trademark, copyright or licensing agreement?
NO      YES     4) Received, or entered into an agreement to receive payments, grants, retainers for
[ ]     [ ]        consulting or honoraria, or equipment from Serious (including payments to an
                   institution to support your activities) having a total monetary value exceeding
                   $25,000 (exclusive of the costs of conducting the Clinical Trial or any other clinical
                   study)?

                                                                                                            y
As an Investigator for the clinical study stated above, by signing below, you certify that you do not have an financial interests in, nor have received
compensation from Serious Pharmaceuticals, Inc. as defined above and in 21CFR Part 54.

If the answer was Yes, to any of the above questions, please attach details of each individual’s disclosable financial arrangements and interests, along
with a description of steps taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests or payments.



___________________________________________________________________________________
Investigator Signature                                                    Date                                                                              10
Study Personnel
   Regulatory Binder
     Qualifications
        CVs for each sub PI
        Licenses for each sub PI
        Human Subject Protection Certification (up to date)
        Lab Certifications

   Financial Disclosure Forms
   Send all to sponsor




                                                               11
Delegation of Responsibilities
   Each person with any role in the study
     Name
     Title
     Role  in this particular study
     Start and Stop Dates of duties
     PI signature or initials




                                             12
The Study
Budget




            13
Request for Lab Support
                      October 31, 2006

   Two weeks         Nalini Merchant
                      LIS Coordinator and Technical Leader, Laboratory
    advance notice    Department of Pathology/Laboratory Services
                      Children’s Memorial Hospital

   Outline all       Re: Stroke With Transfusions in pediatric subjects with sickle cell anemia and previous
                      stroke

    known lab         Dear Ms. Merchant:

    procedures        I am contacting you on behalf of Dr. Alexis Thompson, Division of Hematology/
                      Oncology, regarding the above referenced study. The protocol will be submitted to the
       Local Labs    Institutional Review Board on October 23, 2006. Because laboratory processing is
                      required by the protocol I am requesting a letter of support from your department.

       Central Lab   We will need the laboratory to process specimens in preparation for send out. We will
                      be shipping the blood to its final destination. The processing fee should be billed to the
        Preparation   study fund number, which I will forward to you once one has been assigned.

                      Instructions on processing blood will be forwarded to you when we receive them.      We
                      will notify you when the study is to begin.

                      Thank you in advance for your assistance and the continued support of the laboratory in
                      our research endeavors. Please do not hesitate to contact me at x8312 if you have any
                      questions.

                      Sincerely,


                      Ashley Telles Brummel
                      Clinical Research Associate
                      Hematology

                                                                                                                   14
Request for
                               October 30, 2006

Pharmacy                       Denise Rizzo, Pharm.D.
                               Jamie Sovcik, Pharm.D.


Support                        Research Pharmacist
                               Children's Memorial Hospital


                               Re: Protocol 111111 - Patients with Sickle Cell Disease and
   Two Weeks Advance          Vaso-occlusive Crisis


    Notice                     Dear Denise,

                               I have enclosed the above referenced protocol on behalf of Dr.

   Outline all known          Alexis Thompson of the Division of Hematology/Oncology. We will
                               be submitting the protocol to the Institutional Review B oard for
                               review on November 1, 2006. Because distribution of medication is
    pharmacy                   required by the protocol I am requesting a letter of support from
                               your department.

    responsibilities           Pharmacy will be responsible for the storage, dispensation,
                               reconstitution and inventory management of the study medication
                               for in-patient use. The study drug will be administered as a
       Randomization duties   continuous IV infusion for 48 hours via infusion pump through a
                               dedicated line.
       Drug Inventory         Thank you in advance for your assistance and the continued
                               support of the pharmacy in our research endeavors. Please do not
                               hesitate to contact me at x8312 if you have any questions.

                               Sincerely,


                               Ashley Telles Brummel
                               Clinical Research Coordinator, Hematology


                                                                                                   15
Medical
Imaging
Application
   If imaging is standard of care (no special instructions) and
    billed to insurance, two weeks notice required
   If imaging will be billed to a fund, or special instructions are
    required, parameters must be received one month prior to
    IRB submission
   The Medical Imaging Research Application Form and a copy
    of the protocol needs to be submitted to Angela Nicholas
    (instructions on The Point)
   Special Imaging Research Requisition forms (purple) will be
    supplied that outline procedures per protocol with the fund
    appropriate fund number (fax to Imaging POS at x6014)
                                                                       16
              Medical Imaging Research Committee Application Form                                     Date:

              Please complete all boxes filled in light yellow and return with a copy
              of the study’s protocol. Please e-mail both to anicholas@childrensmemorial.org

                             Principal Investigator

Application                           Department                                                     Box #:



for Medical                        Phone Number

                           Research Assistant or
                           Other Contact Person

Imaging                             Department

                                   Phone Number
                                                                                                     Box #:




Services               Radiologist Investigator for
                       Research Study (if known)

                                     Title of Study


                              IRB Deadline Date:
                                 Length of Study
              Anticipated Number of Participants                               Age Range of Participants
                 Is this study multi-institutional?       [ ] Yes            [ ] No
                     Source of Funding for Study


              Please fill in the following for each type of Medical Imaging exam and indicate the Payment Source
                   Medical Imaging Exam               Body Part           Protocol Type Payment Source*
                 Choose from Dropdown Menu                                Choose        Choose
                 Choose from Dropdown Menu                                Choose        Choose
                 Choose from Dropdown Menu                                Choose        Choose
                 Choose from Dropdown Menu                                Choose        Choose
                 Choose from Dropdown Menu                                Choose        Choose
                 Choose from Dropdown Menu                                Choose        Choose
                 Choose from Dropdown Menu                                Choose        Choose
                 Choose from Dropdown Menu                                Choose        Choose

                           Additional Information:




              *Patient Insurance: Exam is clinically indicated and clinically paid, the exam will be billed to pt. insurance.
              Drug Company: The funding for the exam will come from a drug company
              Non-Drug Company: Government sponsored. (NIH, Philanthropy, Grants)                                               17
Letters of
Support                 Date:        November 1, 2007

                        To:          Thompson, Alexis, MD

   Costs               From:        O’Gorman, Maurice, Ph.D.
                                     Vice Chair - Pathology and Laboratory Medicine


   Submission Packet                Nalini Merchant
                                     LIS Coordinator and Technical Leader, Laboratory


   Regulatory Binder   RE:          Lab Letter of Support



   Forward IRB         This letter confirms the laboratory’s support for your research study entitled:
                         “Re: Stroke With Transfusions in pediatric subjects with sickle cell anemia and
                        previous stroke.”
    Approval
    Documents and       According to your email dated November 1, 2006 the laboratory’s participation
                        will be limited to Specimen processing only. These charges will be billed to your
                        fund number.
    Fund Numbers
                        Upon approval of the study, it is imperative that you notify Nalini Merchant
                        (x4773) immediately to establish the pricing, processing protocols, training and
                        the development of computer codes.

                        A fund number(s), protocol and copies of the documents stating required lab
                        tests must be forwarded to Nalini Merchant before the study can be initiated. All
                        charges (established with the Laboratory) will be billed to your fund number.


                        Cc:          Gregg Glowacz, MS
                                     Administrator, Pathology and Laboratory Services
                                     Carla Lozano, BA
                                     Research Project Coordinator                                    18
Option 2          June 14, 2007


E.g. Radiation    Northwestern Memorial Hospital
                  Radiation Oncology
 Draft Letter    Galter Pavilion LC-178
                  251 East Huron Street
                  Chicago, Illinois 60611
 Submit to
                  To:    Stewart Goldman, MD
  Department             Carrie Kempler, MPH


  for Signature   Re:    Radiation Letter of Support


                  I am writing to extend support from the Radiation Department of Northwestern Memorial
                  Hospital for your research study titled: COG ACNS0222: A Phase II Study of Motexafin-
                  Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for
                  Intrinsic Pontine Glioma of Childhood.

                  Radiation therapy will be administered at a daily dose of 1.8 Gy for 30 treatments over 6
                  weeks. Total dose will therefore be 54 Gy. Data required for the QARC review will be
                  made available within the time period required by the study.

                  Please let my office know when a patient has been registered to this protocol. In
                  addition, please notify me if there are any revisions or amendments to the protocol. I can
                  be reached at 312.926.2520.


                  Sincerely,


                  MaryAnne Marymont, M.D.
                  Northwestern Memorial Hospital
                                                                                                           19
Proposed Budget
   Study Category – NIH or Pharma
   Per Patient Cost
     UnitCost
     Frequency

   One Time Costs
     IRB Fees
     Any Setup Fees (Pharmacy, Lab)
     Study Preparation Fees (Administrative Costs)



                                                      20
Budget Considerations
   Startup Costs
        Personnel time to attend PI Meeting
        Preparation of Regulatory Documents
        IRB submission time
             Informed Consent review and preparation
   Time to conduct of the study
        Time to schedule visits and procedures
        Phone calls to patients and other departments
        Preparation time for patient visits
        Data Entry after visits
        Collecting reviewing lab results
        Interim Monitoring preparation and visit time
        Time for data clarification
        Screen Failure costs
   IRB Fees (and preparation time)
        Initial submission
        Amendments
        Progress Reports
   Closeout Costs
        Record archiving costs
                                                         21
                                                                                                                                                  Event
Study Budget Draft                                                          Day 0         Day 1         Day2          Day 3         Day 30        Total

                                                                                                              Hrs 0-24
                                                                                      Hrs 0-24 of Hrs 24-48 Post-
Procedures                                    Unit Cost         Freq        Screening Infusion    of Infusion Infusion              Follow-up

Informed Consent                                          45           1            45                                                                    45

Inclusion/Exclusion                                       45           1            45                                                                    45

Medical History/Physical Examination                      375          1            375                                                                   375

Interval History                                          15           4                          15            15            15             15           60

Interval Physical Examination                             31           4                          31            31            31             31           124

Adverse Events Review                                     29           4                          29            29            29             29           116

Concomitant Medication Review                             23           5            23            23            23            23             23           115

Study Drug Preparation                                    100          2                          100          100                                        200

Study Drug Administration                                 100          2                          100          100                                        200

Chest x-ray                                               281          2            281                        281                                        562

Pain Scales                                               10           11           10            30            30            30             10           110

PK (draw, process, store)                                 40           7            40            120           40            80                          280

Serum sPLA2 Activity (draw, process, store)               40           4            40            40            40            40                          160
Serum sPLA2 Concentration (on-site
analysis)*                                                366          1            366                                                                   366
Serum sPLA2 Concentration (draw, process,
store)                                                    40           7            40            120           40            80                          280

Chemistry Panel & CBC                                     37           5            37            37            37            37             37           185

Serum c-reactive protein                                  20           4            20            20            20            20                          80

Urinalysis                                                21           2            21                          21                                        42

Urine Pregnancy Test                                      32           1            32                                                                    32

Investigator/Physician Fee                                115          5            115           115          115            115         115             575

Study Coordinator Fee                                     150          5            150           150          150            150         150             750

Patient Stipend                                           50           3                          25            25            50             50           150

Dry Ice                                                   30           2                                                                                  60



Visit Total                                                                      1640             955          1097           700         460

                                                                                                                                                                22
Per Patient Total                                                  4912                                                                               4912
Other Costs

Pharmacy Startup Fee                                                500             1                                                                 500

IRB Startup Fee                                                    2000             1                                                                2000
IRB Annual Review Fee                                               500             1                                                                 500

IRB Amendment Fee                                                   500             1                                                                 500
Study Preparation Fee                                              1500             1                                                                1500



Total Other Costs                                                              5000



* T hese procedures may need to be repeated in order to determine patient eligibility. Repeat procedures will be reimbursed at the same unit cost.

Screen Fails will be reimbursed up to $921.00 (Serum sPLA2 Concentration x2 maximum, Investigator/Physician Fee, Study Coordinator Fee).




                                                                                                                                                     23
Patient Reimbursement Costs

 Verify patient reimbursement schedule
  with sponsor
 Confirm reimbursement in budget
 Include reimbursement amount and
  schedule in Parent and Individual Consent
  forms
     Consider
             if appropriate to be included in
     Adolescent Assent Forms

                                                24
Contracts
   Budget Negotiated with sponsor
    (PI Approved)
   Text forwarded to OSP
      Norene McWilliams
          755-6561

   Signatures
   Ensure Contract is Executed Prior to
    actual study implementation
   File all finance and contract records

                                            25
IRB Initial Submission
   OSP Routing Form
       Budget
       Project Description
       Required Signatures
   Study Personnel Form (New!)
   Research Plan (PI and/or Study Coordinator
   Protocol
   Investigator’s Brochure
   Revised Consent and Assent Forms (CMH
    versions)
   Patient Questionnaires
   Any additional promotional materials or
    patient documents
   Please visit the IRB site on The Point for
    complete submission requirements
                                                 26
Revised Consent and Assent
Forms

   CMH HIPAA Language
   Send to Sponsor for Approval
   Include Appropriate Sponsor Version
   Include Date and CMH Version in Footer
   Appropriate Signature Lines, Dates and Times



                                                   27
                                                                                                                                                       Previous
                                                                                                                    Proposal #
                                                                                                                                                     Proposal #




OSP Routing
                                                  Office of Sponsored Programs (OSP)                        OSP
                                                                                                                                                      Previous
                                                                                                                       IACUC #                      CMH Fund #
                                                  Proposal Routing Form                                     Use
                                                                                                            Only
                                                                                                                         IRB #                           CFDA #
                                   Form for OSP Use Only, Do Not Send to Sponsor                                         IBC #




Form                  OSP
                  Due Date

                         Principal
                      Investigator
                                                  Sponsor
                                                 Due Date


                                   Geoffrey Allen,M.D.
                                                                                  Please note the OSP Due Date is 7 business days prior to the Sponsor Due Date

                                                                                                                  Email gallen@childrensmemorial.org
                                                                                                                 Phone (773) 880-3732

                  Additional Contact Person at CMH Such as Project Coordinator or Administrative Assistant (If Applicable)    Ashley Telles Brummel, CRA



  Budget
                         Subcontract From (If Applicable)
                      Example: Northwestern University

                                              Sponsor
                                                        Serious Pharmaceuticals, Inc.
                 Example: National Institutes of Health

  Project                 Project Title
                     (provide clinical trial A Multicenter, Open-Label Study to Compare On-Demand Treatment Study


   Description    protocol number when
                              applicable)


                                                                                Check only one for each category


  Required      1.   Type of Support
                      Internal
                      External
                                            2.    Type of Proposal
                                                 New / Initial
                                                 Continuation
                                                                           3.    Type of Award
                                                                                 Grant
                                                                                 Contract
                                                                                                          4.     Type of Sponsor
                                                                                                                 NIH
                                                                                                                 NIH Subcontract
                                                                                                                                                           Foundation
                                                                                                                                                           Association
                                                 Renewal                         Subcontract                     Federal (Not NIH)                         University


   Signatures                                    Supplement
                                                 Revision
                                                 Transfer
                                                                                 Clinical Trial
                                                                                 Cooperative Agreement
                                                                                 Fellowship
                                                                                                                 Federal (Not NIH) Subcontract
                                                                                                                 Subcontract
                                                                                                                 Corporation
                                                                                                                                                           Local Govt.
                                                                                                                                                           State of Illinois
                                                                                                                                                           Society


                  INITIAL or CONTINUATION Budget Period                                           ENTIRE Budget Period (New, Renewal, Revision Proposals Only)
                  Direct Costs         $0                   From     01/        31/   2007        Direct Costs           $0                  From    01/     31/       2007
                  Facilities &                                                                    Facilities &
                  Administration       $0                    To      01/        31/   2008        Administration         $0                   To     01/     31/       2009
                  F&A      %                                                                      F&A     %
                  Total Request        $0                                                         Total Request          $0


                  List ONLY CMH Principal Investigator, Co-Investigators and Faculty                                                    Check all that        For this project only,
                  All individuals listed below must review and sign page 3                                                                 apply            list % effort applicable
                                                                                                                                                                               CMH
                                                                                                                                       Co-                   Paid by           Cost-
                  Name                                             Department                     Division / Program                   Inv       Faculty     Sponsor           Share

                  Geoffrey Allen, M.D.                             Pediatrics                     Hematology/Oncology                   PI                      0%             0%
                                                                   Click Here to Choose Dept.                                                                      %              %

                                                                   Click Here to Choose Dept.                                                                      %              %

                                                                   Click Here to Choose Dept.                                                                      %              %

                                                                   Click Here to Choose Dept.                                                                      %              %

                                                                   Click Here to Choose Dept.                                                                      %              %

                                                                   Click Here to Choose Dept.                                                                      %              %

                                                                   Click Here to Choose Dept.                                                                      %              %
                                                                   Click Here to Choose Dept.                                                                      %              %
                                                                                                                                                                                       28
Submission   December 29, 2007


Cover        Ellen R. Brooks, Ph.D.
             Chair, Institutional Review Board
             Children's Memorial Research Center
             Children’s Memorial Institute for Education & Research (CMIER)
Letter       2300 Children’s Plaza, #205
             Chicago, IL 60614-3394

             RE: Protocol 3090A1-400-AA: A Multicenter, Open-Label Study to Compare On-
             Demand Treatment With 2 Prophylaxis Regimens in Subjects With Severe Hemophilia B

             Principle Investigator: Geoffrey Allen, M.D.

             Dear Dr. Brooks:

             Attached please find the submission documents for the above-referenced study.

             Enclosed you will find the following:

                    •       The signed Office of Sponsored Programs Proposal Routing Form
                    •       Research Plan
                    •       Protocol (version and date)
                    •       Investigator’s Brochure (version and date)
                    •       Safety Attachment for Investigator’s Brochure
                    •       Subject Instruction Manual
                    •       Subject Quick Reference Guide
                    •       eDiary Subject Screens
                    •       Consent Forms for an adult, a child and adolescent assent (version date)

             In the approval letter, please specify (version and date). If you have any questions, please
             feel free to contact me at x8312.

             Sincerely,                                                                                     29
                                                     IRB PROTOCOL PERSONNEL LIST


Instructions: List all Individuals who will have access to study data (i.e. Co-PI's, research assistants, laboratory technicians, CRA's, etc)


IRB Number (if known): 2004-12323
Title of Project:Recombinant Antihemophilic Factor (rAHF-PFM) Manufactured and Formulated without Added Human or Animal
PI: Alexis Thompson, M.D., MPH
CRA/Research Assistant: Ashley Brummel

Note: All listed personnel must be current in their Human Subjects Education Requirement
                                                                                                                      Role in Study: Please
Version Date: <date>                                                                                                    Enter "Yes" or "No"
                                                                          Phone                                        Interacts    Obtains
        Last Name      First Name         Division       Department      Number             Email Address             w/Subjects Consent

Thompson             Alexis           Hematology       Hem/Onc         880-6381      a-thompson@northwestern.edu      Yes        Yes
Allen                Geoffrey         Hematology       Hem/Onc         880-3732      gallen@childrensmemorial.org     Yes        Yes
Liem                 Robert           Hematology       Hem/Onc         880-3977      rliem@childrensmemorial.org      Yes        Yes
                                                                                     akmack@childrensmemorial.or
Mack                 Kyle             Hematology       Hem/Onc         880-6928      g                                Yes        Yes
                                                                                     sgamerman@childrensmemori
Gamerman             Susan            Hematology       Hem/Onc         880-4620      al.org                           Yes        Yes
                                                                                     lvaldiviez@childrensmemorial.o
Valdiviez            Leticia          Hematology       Hem/Onc         880-8903      rg                               Yes        No
                                                                                     abrummel@childrensmemorial.
Brummel              Ashley           Hematology       Hem/Onc         880-8312      org                              Yes        No
Hess                 Pauline          Hematology       Hem/Onc         880-3335      phess@childrensmemorial.org      No         No

Silva                Mercedes         Laboratory       Pharmacy        975-8840      msilva@childrensmemorial.org No             No

Sovcik               Jamie            Pharmacy         Pharmacy        880-4653      jsovcik@childrensmemorial.org Yes           No


                                                                                                                                          30
IRB Approval Documents
   Forward all approval documents to Sponsor
     IRB Approval Letter (stating version approved)
     Stamped consent and assent forms
   Forward all approval documents to appropriate
    departments
     Lab
     Pharmacy
     Medical Imaging
     Cardiology
     Radiation


                                                       31
Other Materials and Preparation
   Regulatory Binder
   Patient Specific Binders or Files
   Create Source Documents for CRF completion
       Sponsor provided or
       Locally Created
   Develop Research Lab Requisitions including fund number
   Patient Tracking Systems
   Complete eCRF and IVRS (Randomization process) Training
   Confirm Shipping Supplies and Procedures
   Confirm Specimen Storage Plan with Lab
   Confirm Drug Storage space dispensing schedule with the Lab
   Confirm all protocol procedures on Medical Imaging Requisition
    Forms
   Develop KIDSDOC Template on Share Point

                                                                     32
                                                                  RESEARCH
                                                                  SPECIMEN
Laboratory                                     SPECIAL SPECIMEN PROCESSING CENTER (SSPC)


Research
                            DEPARTMENT OF PATHOLOGY AND LABORATORY SERVICES
Requisition Form                REQUEST FOR RESEARCH TESTING AND SPECIMEN
                                               PROCESSING
                                  CONTACT: SPECIAL SPECIMEN PROCESSING CENTER (SSPC)
                                       PHONE#: 1-773-975-8840 FAX# 1-773-880-4089


    Please print on blue   DATE:
                            Title of Study:
     paper                  Fund Number:                        Investigator:
                            Contact Person:                       Extension:                  PAGER:
    Include brief          Patient Name or ID of sample:
     instructions                                             SERVICES


     (attached, please do   Check all services requested:
                                         Phlebotomy

     not state “follow
                                         Specimen Send Out/Delivery (Attach special instruction)
                                         Specimen Testing and Analysis


     protocol”)
                                                      TESTS REQUESTED

                                       Name of the Test                           Tube Type

    Include Fund
     Number (from OSP)
                                                          EXTRA TUBES DRAWN
                                                           Please Specify Below

                                      Number of Tubes                             Tube Type




                             FOR ANY SPECIAL HANDLING PLEASE ATTACH SPECIAL INSTRUCTION!
                                                                                                       33
Laboratory Req. Form Instructions
   What tubes are needed and if tubes are supplied
   How long and at what speed the sample should be
    centrifuged
   How to aliquot the samples
   Include labels with subject identification
   Storage instructions
   Shipping instructions if necessary
   Include air bills and packaging materials (or if the lab
    needs to supply)
   Any special instructions pertaining to specimens (spin
    and keep refrigerated, call _____ @ ext. 8888 for pickup


                                                           34
Children's Memorial Hospital                             ADOPTED: _01/04_____
                                                         REVISED: _05/23/05____
Department of Pathology                                  REVIEWED: __________
and Laboratory Services                                  REVIEWED: __________
                                                         REVIEWED: __________
LIS POLICY AND PROCEDURE

     TITLE:      Procedure for Processing charges of Research specimens.

     POLICY: In order to provide appropriate charges to all research specimens
     for processing the following codes have been created in MISYS.

     PROCEDURE: All research specimens are to be charged using the following
     MYSIS codes:

           1. “STORE1”= 1 to 5 stored samples = $5.00
           2. “STORE2”= more than 5 samples = $8.00
           3. “STORE3”= 1 to 50 samples for 6 months = $25.00 (storage only-
              without processing charges)
           4. “PROC1”= One Spin and prepare ONE aliquot = $6.00
           5. “PROC2” = One Spin and prepare MORE THAN ONE aliquot =
              $11.00
           6. “PROC3” = Two Spins (other processing) and any aliquot(s) = $15.00
           7. “PROC4” = Complex protocol driven processing = $25.00 (for e.g.
              multiple spins, multiple aliquots, long incubation time, addition of
              other reagents, etc)
           8. “HAN1” = Packaging and shipping materials provided by customer
              (SSPC labor only) = $5.00
           9. “HAN2” = Packaging and labor provided by SSPC, customer provides
              postage/delivery = $9.00
           10.“SHIP1” = 2 day = $20.00
           11. “SHIP2” = Overnight = $30.00
           12. “SUPPLY” = $1.50 = 10 2ml cryovials
           13. “DRYICE” = $20.00 (about 8.5 lbs)

           Note: Note that shipping and handling charges are now separate.



                                                                                     35
Regulatory
Binder
   Monitoring Log
   Delegation of Responsibilities Log
   Financial Disclosure Forms
   1572
      Staff CVs
      Licenses
   Sponsor Correspondence
   CMH Correspondence
   IRB Documents
   Current Protocol
   Investigator’s Brochure
   Current Stamped Consent and Assent
    Forms


                                         36
Key Personnel

   Harmony Maple (OSP)
   Norene McWilliams (OSP)
   April Baker (IRB Manager)
   Denise Rizzo and Jamie Sovcik (Pharmacy)
   Nalini Merchant (Lab)
   Angela Nicholas (Medical Imaging)
   Sheila McGuire (Cardiology)
   Eric Gasber (CMRC – KIDSDOC Template of Share
    Point)

                                                    37
38
39

				
DOCUMENT INFO
Description: Application Form for Cvs Pharmacy document sample