Tag: AUC (area under the curve)

BA-BE Studies: SOP for Managing Medical Emergencies at Clinical Site – V 2.0 Standard Operating Procedure for Managing Medical Emergencies at Clinical Sites during BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/150/2025 Supersedes SOP/BA-BE/150/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a structured…

Read More “BA-BE Studies: SOP for Managing Medical Emergencies at Clinical Site – V 2.0” »

BA-BE Studies: SOP for Safety Reporting to Sponsor and Ethics Committee – V 2.0 Standard Operating Procedure for Safety Reporting to Sponsor and Ethics Committee in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/149/2025 Supersedes SOP/BA-BE/149/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define…

Read More “BA-BE Studies: SOP for Safety Reporting to Sponsor and Ethics Committee – V 2.0” »

BA-BE Studies: SOP for Controlling Noise and Environmental Disturbances – V 2.0 Standard Operating Procedure for Control of Noise and Environmental Disturbances in BA/BE Clinical Facilities Department BA-BE Studies SOP No. SOP/BA-BE/147/2025 Supersedes SOP/BA-BE/147/2022 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…

Read More “BA-BE Studies: SOP for Controlling Noise and Environmental Disturbances – V 2.0” »

BA-BE Studies: SOP for Protocol Deviation Reporting and Escalation – V 2.0 Standard Operating Procedure for Reporting and Escalation of Protocol Deviations in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/148/2025 Supersedes SOP/BA-BE/148/2022 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 a structured and…

Read More “BA-BE Studies: SOP for Protocol Deviation Reporting and Escalation – V 2.0” »

BA-BE Studies: SOP for Ongoing Subject Medical Surveillance – V 2.0 Standard Operating Procedure for Ongoing Medical Surveillance of Subjects in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/146/2025 Supersedes SOP/BA-BE/146/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a systematic approach for the…

Read More “BA-BE Studies: SOP for Ongoing Subject Medical Surveillance – V 2.0” »

BA-BE Studies: SOP for Ensuring Study Staff Role Clarity – V 2.0 Standard Operating Procedure to Ensure Study Staff Role Clarity in BA/BE Clinical Trials Department BA-BE Studies SOP No. SOP/BA-BE/145/2025 Supersedes SOP/BA-BE/145/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To ensure clear definition, documentation,…

Read More “BA-BE Studies: SOP for Ensuring Study Staff Role Clarity – V 2.0” »

BA-BE Studies: SOP for Clinical Trial Material Storage at Site – V 2.0 Standard Operating Procedure for Storage of Clinical Trial Material at Site in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/144/2025 Supersedes SOP/BA-BE/144/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a…

Read More “BA-BE Studies: SOP for Clinical Trial Material Storage at Site – V 2.0” »

BA-BE Studies: SOP for Gender-Specific Risk Management in BA/BE – V 2.0 Standard Operating Procedure for Gender-Specific Risk Management in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/143/2025 Supersedes SOP/BA-BE/143/2022 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 a structured procedure for identifying, mitigating,…

Read More “BA-BE Studies: SOP for Gender-Specific Risk Management in BA/BE – V 2.0” »

BA-BE Studies: SOP for Clinical Trial Incident Reporting – V 2.0 Standard Operating Procedure for Clinical Trial Incident Reporting in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/142/2025 Supersedes SOP/BA-BE/142/2022 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 a standardized and compliant method for…

Read More “BA-BE Studies: SOP for Clinical Trial Incident Reporting – V 2.0” »

BA-BE Studies: SOP for Weekend and Holiday Subject Management – V 2.0 Standard Operating Procedure for Managing Subjects During Weekends and Holidays in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/141/2025 Supersedes SOP/BA-BE/141/2022 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 procedures and…

Read More “BA-BE Studies: SOP for Weekend and Holiday Subject Management – V 2.0” »