SOPs for BA-BE Studies V 2.0

To establish a standardized procedure for registering Bioequivalence (BE) trials on the Clinical Trials Registry – India (CTRI) platform, in compliance with Indian regulatory requirements prior to trial initiation.
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To define the process for developing, reviewing, and finalizing informed consent documents (ICDs) including Informed Consent Forms (ICFs), Subject Information Sheets (SIS), and other relevant materials for use in BA/BE studies, in accordance with ICH GCP, Schedule Y, and EC requirements.
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To establish a standard process for the translation and back-translation of Informed Consent Forms (ICFs) and Subject Information Sheets (SIS) into regional languages for use in Bioavailability/Bioequivalence (BA/BE) studies, ensuring clarity, accuracy, and cultural appropriateness.
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To define the procedure for conducting, documenting, and storing audio-visual (AV) recordings of the informed consent process for BA/BE studies conducted in India, as per the requirements of the CDSCO and Indian regulatory authorities.
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To define the procedure for proper documentation, classification, indexing, and long-term archival of regulatory correspondence related to Bioavailability/Bioequivalence (BA/BE) studies to ensure traceability and compliance with applicable guidelines.
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To define the standard procedure for establishing, organizing, maintaining, and archiving the Investigator Site File (ISF) for BA/BE clinical studies, ensuring regulatory and GCP compliance throughout the study lifecycle.
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To define the procedure for ensuring accurate and consistent integration between the study protocol and the Statistical Analysis Plan (SAP) in Bioavailability/Bioequivalence (BA/BE) studies, maintaining alignment between study design and statistical methodology.
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To define the standard procedure for the blinding and unblinding of treatment assignments in Bioavailability/Bioequivalence (BA/BE) studies, in order to maintain the integrity of the study and ensure unbiased assessment of results.
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To define the systematic approach for conducting a risk assessment of the study protocol in Bioavailability/Bioequivalence (BA/BE) studies, ensuring potential risks to subject safety, data quality, and regulatory compliance are identified, evaluated, and mitigated.
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To define a standardized procedure for the preparation, review, approval, and distribution of the Clinical Investigator’s Brochure (CIB) for Bioavailability/Bioequivalence (BA/BE) studies, ensuring it contains comprehensive safety, efficacy, and pharmacological information for investigators.
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