Clinical Research

1. Clinical Research Study Implementation at Children�s Memorial Hospital Ashley Brummel, Clinical Research Coordinator

2. 2 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

3. 3 Confidential Disclosure AgreementExample

4. 4 CDA Signatures

5. 5 Site Information Questionnaire

6. 6 Eligible Patients Review Protocol for Inclusion/Exclusion Criteria Review Database for Eligible Patients Prepare Working List Review List with Staff

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8. 8 The 1572

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11. 11 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

12. 12 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

13. 13 The Study Budget

14. 14 Request for Lab Support Two weeks advance notice Outline all known lab procedures Local Labs Central Lab Preparation

15. 15 Request for Pharmacy Support Two Weeks Advance Notice Outline all known pharmacy responsibilities Randomization duties Drug Inventory

16. 16 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)

17. 17 Application for Medical Imaging Services

18. 18 Letters of Support Costs Submission Packet Regulatory Binder Forward IRB Approval Documents and Fund Numbers

19. 19 Option 2 E.g. Radiation Draft Letter Submit to Department for Signature

20. 20 Proposed Budget Study Category � NIH or Pharma Per Patient Cost Unit Cost Frequency One Time Costs IRB Fees Any Setup Fees (Pharmacy, Lab) Study Preparation Fees (Administrative Costs)

21. 21 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

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24. 24 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

25. 25 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

26. 26 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

27. 27 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

28. 28 OSP Routing Form Budget Project Description Required Signatures

29. 29 Submission Cover Letter

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31. 31 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

32. 32 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

33. 33 Laboratory Research Requisition Form Please print on blue paper Include brief instructions (attached, please do not state �follow protocol�) Include Fund Number (from OSP)

34. 34 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

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36. 36 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

37. 37 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)

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