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| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": "v_adeair_new.sas", |
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| "Validation Status": "Not Started", |
| "Delivery Notes": "Comments are added to the \"Comment Tracker\"", |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADEFF", |
| "Program Name": null, |
| "Risk Level (H, M, L)": "H", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-08", |
| "Validation Status": "Not Started", |
| "Delivery Notes": "Comments are added to the \"Comment Tracker\"", |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADEX", |
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| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
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| "Validation Programmer Name": "Cristi Morgan", |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-12", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Validation Programmer Name": "Kirti Patel", |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-12", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADEXSUM", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Kirti Patel", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-12", |
| "Validation Status": "Not Assigned", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADICEB", |
| "Program Name": null, |
| "Risk Level (H, M, L)": "H", |
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| "Included in delivery": "Y", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": "v_adiceb_new.sas", |
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| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-09", |
| "Validation Status": "Not Started", |
| "Delivery Notes": "Mismatch due to data issue (PARAMCD=\"NON COMLIANCE\"). Comments are added to the \"Comment Tracker\"", |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADLB", |
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| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
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| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
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| "Validation Programmer Name": "Kirti Patel", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-12", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-04", |
| "Validation Status": "Not Started", |
| "Delivery Notes": "One variable failed to match. Comments are added to the \"Comment Tracker\"", |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADPRODEV", |
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| "Production Programmer Name": "John Doe", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Don Jose", |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-12", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADQS", |
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| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Don Jose", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-11", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADRE", |
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| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": "v_adre", |
| "Validation Programmer Name": "Yuri Lu", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-05", |
| "Validation Status": "Not Started", |
| "Delivery Notes": "added comments to the tracker.", |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADSCRI", |
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| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Yuri Lu", |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-12", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADVS", |
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| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-12", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Dataset Name": "ADXACSUM", |
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| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-15", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| } |
| ], |
| "TLFs": [ |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.1.1.1", |
| "Title": "Disposition", |
| "Standard Template Reference": null, |
| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "H", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Date Validation Completed (YYYY-MM-DD)": null, |
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| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.1.1.2", |
| "Title": "Subject treatment status by treatment period (Safety analysis set)", |
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| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "H", |
| "Test Method": null, |
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| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": null, |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.1.2", |
| "Title": "Recruitment per region, country and site", |
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| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "L", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Yuri Lu", |
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| "Date Validation Completed (YYYY-MM-DD)": null, |
| "Validation Status": "Not Started", |
| "Delivery Notes": "comments added in the tracker", |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.1.3.1", |
| "Title": "Important protocol deviations (Safety analysis set)", |
| "Standard Template Reference": null, |
| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "H", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Don Jose", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-09", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.1.3.2", |
| "Title": "Important protocol deviation by treatment period (Safety analysis set)", |
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| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "H", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
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| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-09", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.1.4", |
| "Title": "Analysis sets", |
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| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "H", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-09", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.1.5", |
| "Title": "Demographics (Safety analysis set)", |
| "Standard Template Reference": null, |
| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "L", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Kirti Patel", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-10", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.1.6", |
| "Title": "Baseline characteristics (Safety analysis set)", |
| "Standard Template Reference": null, |
| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "L", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Yuri Lu", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-10", |
| "Validation Status": "Not Assigned", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.3.3.1", |
| "Title": "Serious adverse events with outcome death by system organ class and preferred term (Safety analysis set)", |
| "Standard Template Reference": null, |
| "Output Kind (Unique, Repeat)": "Unique", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "H", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Yuri Lu", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-15", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.3.3.2", |
| "Title": "Serious adverse events with outcome death – Key subject information (Safety analysis set)", |
| "Standard Template Reference": null, |
| "Output Kind (Unique, Repeat)": "Repeat", |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "H", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Yuri Lu", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-15", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.3.4.1", |
| "Title": "Serious adverse events by system organ class and preferred term (Safety analysis set)", |
| "Standard Template Reference": null, |
| "Output Kind (Unique, Repeat)": null, |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "L", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
| "Validation Programmer Name": "Cristi Morgan", |
| "Val Projected Date": "2025-09-15", |
| "Date Validation Completed (YYYY-MM-DD)": "2025-09-15", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Table", |
| "Output #": "14.3.4.2", |
| "Title": "Serious adverse events – Key subject information (Safety analysis set)", |
| "Standard Template Reference": null, |
| "Output Kind (Unique, Repeat)": null, |
| "Program Name": null, |
| "Output Name": null, |
| "Risk Level (H, M, L)": "L", |
| "Test Method": null, |
| "Additional Test Information": null, |
| "Included in delivery": "Y", |
| "Production Programmer Name": "John Doe", |
| "Projected Completion Date": "2025-08-29", |
| "Production Status": "Ready for QC", |
| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Val Projected Date": "2025-09-15", |
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| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
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| { |
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| "Date Validation Completed (YYYY-MM-DD)": null, |
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| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
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| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-10", |
| "Validation Status": "Not Started", |
| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-04", |
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| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Date Validation Completed (YYYY-MM-DD)": "2025-09-04", |
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| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
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| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| }, |
| { |
| "Output Type (Table, Listing, Figure)": "Figure", |
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| "Date ready for QC (YYYY-MM-DD)": "2025-08-29", |
| "Validation Program (if any)": null, |
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| "Date Validation Completed (YYYY-MM-DD)": null, |
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| "Delivery Notes": null, |
| "Date QC and Production Verification Completed - Post DBL/Snapshot (YYYY-MM-DD)": null |
| } |
| ] |
| } |
| } |
