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BA-BE Studies: SOP for Protocol and SAP (Statistical Analysis Plan) Integration – V 2.0 Standard Operating Procedure for Protocol and SAP (Statistical Analysis Plan) Integration in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/027/2025 Supersedes SOP/BA-BE/027/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define…
BA-BE Studies: SOP for Maintaining Investigator Site File (ISF) – V 2.0 Standard Operating Procedure for Maintaining Investigator Site File (ISF) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/026/2025 Supersedes SOP/BA-BE/026/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the standard procedure for…
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BA-BE Studies: SOP for Archival of Regulatory Correspondence – V 2.0 Standard Operating Procedure for Archival of Regulatory Correspondence in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/025/2025 Supersedes SOP/BA-BE/025/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for proper documentation, classification,…
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BA-BE Studies: SOP for Audio-Visual Consent Recording in India – V 2.0 Standard Operating Procedure for Audio-Visual Consent Recording in India for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/024/2025 Supersedes SOP/BA-BE/024/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for conducting,…
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BA-BE Studies: SOP for Translation and Back-Translation of Consent Forms – V 2.0 Standard Operating Procedure for Translation and Back-Translation of Consent Forms in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/023/2025 Supersedes SOP/BA-BE/023/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a standard…
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BA-BE Studies: SOP for Developing Informed Consent Documents – V 2.0 Standard Operating Procedure for Developing Informed Consent Documents in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/022/2025 Supersedes SOP/BA-BE/022/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process for developing, reviewing, and…
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BA-BE Studies: SOP for Registration of BE Trials on CTRI – V 2.0 Standard Operating Procedure for Registration of BE Trials on CTRI Department BA-BE Studies SOP No. SOP/BA-BE/021/2025 Supersedes SOP/BA-BE/021/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a standardized procedure for registering…
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BA-BE Studies: SOP for Pre-Submission Meeting with Regulatory Authorities – V 2.0 Standard Operating Procedure for Pre-Submission Meeting with Regulatory Authorities in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/020/2025 Supersedes SOP/BA-BE/020/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a structured procedure for…
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BA-BE Studies: SOP for Protocol Amendment Approval Process – V 2.0 Standard Operating Procedure for Protocol Amendment Approval Process in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/019/2025 Supersedes SOP/BA-BE/019/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for initiating, reviewing, approving,…
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BA-BE Studies: SOP for IEC/IRB Continuing Review Applications – V 2.0 Standard Operating Procedure for IEC/IRB Continuing Review Applications in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/018/2025 Supersedes SOP/BA-BE/018/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To outline the procedure for preparing and submitting…
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