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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 Re
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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
7. 7
8. 8 The 1572
9. 9
10. 10
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
22. 22
23. 23
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
30. 30
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
35. 35
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)
38. 38
39. 39