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BA-BE Studies: SOP for Managing Subject Dropouts and Replacements in BA/BE Studies – V 2.0 Standard Operating Procedure for Managing Subject Dropouts and Replacements in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/107/2025 Supersedes SOP/BA-BE/107/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a…
BA-BE Studies: SOP for Managing Female Volunteers in BA/BE Trials – V 2.0 Standard Operating Procedure for Managing Female Volunteers in BA/BE Trials Department BA-BE Studies SOP No. SOP/BA-BE/106/2025 Supersedes SOP/BA-BE/106/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a standardized procedure for the…
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BA-BE Studies: SOP for Volunteer Identification and Screening Logs – V 2.0 Standard Operating Procedure for Volunteer Identification and Screening Logs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/105/2025 Supersedes SOP/BA-BE/105/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for proper…
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BA-BE Studies: SOP for Maintaining Privacy and Confidentiality of Volunteers – V 2.0 Standard Operating Procedure for Maintaining Privacy and Confidentiality of Volunteers in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/104/2025 Supersedes SOP/BA-BE/104/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a standardized…
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BA-BE Studies: SOP for Emergency Exit and Fire Drill Plan at Clinical Site – V 2.0 Standard Operating Procedure for Emergency Exit and Fire Drill Plan at Clinical Site in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/103/2025 Supersedes SOP/BA-BE/103/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026…
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BA-BE Studies: SOP for Contingency Plan for Power or Equipment Failure – V 2.0 Standard Operating Procedure for Contingency Plan for Power or Equipment Failure in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/102/2025 Supersedes SOP/BA-BE/102/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish…
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BA-BE Studies: SOP for Training of Clinical Staff on Protocol Amendments – V 2.0 Standard Operating Procedure for Training of Clinical Staff on Protocol Amendments in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/101/2025 Supersedes SOP/BA-BE/101/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define…
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BA-BE Studies: SOP for Clinical Phase Audit Preparation – V 2.0 Standard Operating Procedure for Clinical Phase Audit Preparation in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/100/2025 Supersedes SOP/BA-BE/100/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process for preparing the clinical…
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BA-BE Studies: SOP for Interim Clinical Monitoring Reports – V 2.0 Standard Operating Procedure for Interim Clinical Monitoring Reports in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/099/2025 Supersedes SOP/BA-BE/099/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for preparing, reviewing, and…
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BA-BE Studies: SOP for Maintaining Blinding in Blinded Studies – V 2.0 Standard Operating Procedure for Maintaining Blinding in Blinded Studies Department BA-BE Studies SOP No. SOP/BA-BE/098/2025 Supersedes SOP/BA-BE/098/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To outline the procedure for maintaining the integrity of…
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