Tenders Are Invited For Data Capture Services – Objectivization Of The Effect Of Complex Spa Medical Rehabilitation Care On Diseases And Chronic Complications Of Type 2 Diabetes Mellitus, Prevention And Progression Of Liver Steatosis - Repeated Announcement

Data Capture Services – Objectivization Of The Effect Of Complex Spa Medical Rehabilitation Care On Diseases And Chronic Complications Of Type 2 Diabetes Mellitus, Prevention And Progression Of Liver Steatosis - Repeated Announcement. The Subject Of This Public Order Is To Ensure The Cooperation Of The Provider (Spa Facility) Within The Framework Of A Clinical Study For Patients With Prescribed Comprehensive Spa Medical Rehabilitation Care (Hereinafter Referred To As Klp) Who Are Simultaneously Diagnosed With Type 2 Diabetes Mellitus Falling Into The Iv/1 Indication Group. This Diagnosis Can Be Given As The Main Indication Of The Stay, Or As A Secondary Diagnosis (Comorbidity). Thus, Patients Admitted To Spa Treatment Primarily For Another Indication, But With The Associated Disease Type 2 Diabetes Mellitus, Can Also Be Included In The Clinical Study. The Aim Of The Conducted Clinical Study Is To Objectify The Effect Of Complex Spa Medical Rehabilitation Care (Klp) On The Disease And Chronic Complications Of Type 2 Diabetes Mellitus (Dmt2), Prevention And Progression Of Hepatic Steatosis In Karlovy Vary. For The Purposes Of This Tender Documentation, A Spa Facility Is Understood As A Registered Provider Of Comprehensive Spa Medical Rehabilitation Care Paid For By Public Health Insurance In The Territory Of Karlovy Vary, Which Has A Valid Permit To Use Natural Healing Resources And At The Same Time Holds The Approval Of The Ministry Of Health To Provide Spa Medical Rehabilitation Care. This Is A Spa Facility Providing Comprehensive Spa Medical Rehabilitation Care According To The Above Requirements And According To The Selected Indication Criteria Of The Clinical Study Objectivation Of The Effect Of Complex Spa Medical Rehabilitation Care On Diseases And Chronic Complications Of Type 2 Diabetes Mellitus, Prevention And Progression Of Liver Steatosis. The Transmission Of Pseudonymized Data Will Take Place According To The Mutually Agreed Schedule Of The Institute Of Spa And Balneology, V. V. I. (Hereinafter Referred To As Ilab), At Specified Intervals, Every Two Months. All Data Will Be Structured, Provided Only With Id Codes Of Individual Patients. Id Codes Must Be Given To The Selected Laboratory Facility, Which Will Be Responsible For Performing Laboratory Diagnostics On All Samples. The Spa Facility Is Responsible For The Correct Use Of Patient Id Codes And It Is Their Responsibility To Ensure That No Confusion Occurs. The Clinical Study Will Only Include Patients Accepted For A Stay In The Form Of Complex Spa Medical Rehabilitation Care (Klp), Which Corresponds To The Contractual Relationship Between The Provider And The Health Insurance Company. The Subject Of This Public Contract Is Not The Preparation Of The Clinical Study Itself, But The Provision Of Related Activities, Including The Collection Of Data And Data On Patients, Without Their Evaluation, And The Transfer Of These Data And Data To The Contracting Authority For Their Further Processing. The Collected Data Will Be Forwarded To Ilab At Set Intervals (Every Two Months), Which Will Process The Resulting Clinical Study Based On Them. In Addition, The Provider Must Ensure: • A Sufficient Number Of Patients Meeting The Criteria For Inclusion (See Appendix No. 3 Zd), • Obtaining Their Informed Consent, • Patient Education, • Performing Diagnostic Procedures, Examinations And Questionnaires (For More Details, See Appendix No. 3 Zd), • Cooperation With The Laboratory Within

31,50,000 - CZK

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Global Tender Document	2878afab-6474-411e-b0f3-e69ee0f15594.html