Tenders Are Invited For Carrying Out Diagnostic Tests As A Central Laboratory As Part Of A Non-Commercial Clinical Trial Project Called Avo-Cll: A Multicenter, Randomized, Open-Label Phase Trial ........

Test Quantity Unit Price Tto Vat Rate Net Value Gross Value 17P 72 Igvh 72 Tp53 72 Total: 1. The Contractor Will Carry Out Tasks As The Central Laboratory For The Centers Participating In The Avo-Cll Study And Will Accept Biological Material From These Centers At The Expense Of The Ordering Party. Currently, 3 Centers Are Planned In Poland (Wałbrzych, Legnica, Warsaw).2. Duration Of The Agreement - 48 Months.3.The Ordering Party Plans To Perform The Indicated Tests For Each Participant Of The Non-Commercial Avo-Cll Clinical Trial - 72 Participants - Excluding Participants Or Tests If They Were Performed Before The Screening Visit Of The Clinical Trial.4.If It Is Necessary To Perform The Tests Again, The Contractor Informs The Ordering Party About This Fact And Performs The Test Again If The Biological Material Allows It And Charges The Ordering Party With The Costs, Except For The Situation In Which The Repetition Of The Test Was Due To Reasons Attributable To The Contractor - Then The Contractor Performs Repeated Tests Without Charging The Ordering Party With Any Costs. 5.Contractor Has An Implemented Quality Management System And Provides Procedures Or Instructions To The Centers Regarding The Preparation And Transport Of Biological Material To The Ordering Party. 6. The Contractor Provides The Ordering Party With Information At Least One Month In Advance About The Contractors Days Off From Work (E.G. Period Of Non-Acceptance Of Biological Material, If Any).7 .The Contractor Shall Immediately Provide Information About Failures Or Other Circumstances Preventing The Receipt Of Material Or The Performance Of Tests. 8. The Contractor Acknowledges That Domestic, Foreign Or International Bodies Responsible For The Supervision Or Control Of Clinical Trials And Independent Auditors Appointed By The Above-Mentioned Authorities Or Auditors Designated By The Sponsor Will Be Able To Audit Or Inspect The Procedures, Devices, As Well As Documents Related To The Study, Including Medical Documentation Regarding The Participants.9. The Contractor Carries Out Or Secures The Transport Of Biological Material From The Centers To The Place Where The Study Is Performed.10. A Person Designated From The Center Notifies The Contractor Or A Person Indicated By The Contractor Of The Need For The Transport Of Biological Material At Least 24 Hours Before The Required Transport, Using Minimum Means Of Communication: Telephone Or E-Mail Contact. The Contractor Will Provide The Ordering Party With Contact Information: Telephone Number And E-Mail Address. The Contractor Will Provide Waybills Or The Payers Number In The Event Of Transport Being Carried Out By A Subcontractor Or Another Solution Indicated By The Subcontractor. The Person Submitting The Request And The Contractor, If Communication Via E-Mail Is Used, Add The Following Address In The Cc Field: [email protected]. Employees Carrying Out The Subject Of The Order Are Trained In Gcp (Good Clinical Practice, I.E. They Have A Certificate Or Employees Carrying Out The Subject Orders Are Obliged To Undergo Gcp Training Provided By The Ordering Party Within The Time Agreed By The Parties. 12. The Test Results Are Available To The Ordering Party No Later Than ... Days From The Date Of Receipt Of The Biological Material. 13. The Contractor And The Ordering Party Will Develop An Order Form Containing Pseudonymized Patient Data (Code Patient, Gender, Center Number, Year Of Birth, Date And Time Of Collecting Biological Material For Each Test, Signature Of The Person Collecting The Material, Signature Of The Person Completing The Form).14. The Test Report (Result) Contains At Least: Patient Code, Gender, Center Number , Year Of Birth, Date And Time Of Collection Of Biological Material For Each Test And A Description Of The Result And The Contractors Markings (Name, Address, Logo, Etc., If Used By The Contractor). The Report Is Submitted To The Center And The Sponsor - Via The It System Or An Encrypted Report File Will Be Sent Via E-Mail. The Test Result Is Electronically Signed (Authorized) Or The Contractor Will Additionally Send The Original Result With The Signature Of The Person Authorizing The Result By Traditional Means.15. The Biological Material After Performing The Indicated Tests Is Disposed Of By The Contractor And Not Processed Further.16. Tests Performed: Del17p - Determination Of The 17P Deletion Using The Fishigvh Method - Igvh Mutation Determination According To Ericll (European Research Initiative On Cll Www.Ericll.Org)Tp53 - Tp53 Mutation Determination