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Proximity card security access to the screening area, wards, drug store, server room, bioanalytical labs, archives, QA & offices |
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Closed circuit cameras in screening area, wards, dining/recreation area and in bioanalytical section |
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Synchronised clocks for accurate sampling and monitoring of vitals |
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Nutritionally balanced and standardised meals |
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Validated computerized temperature and humidity monitoring system and alarm system |
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Fire proof archives for storage of hard copies and electronic data |
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Color-coded uniforms for study volunteers |
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Validated and 21 CFR part 11 compliant software |
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Biomedical waste management as per statutory requirements |
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Disaster management plan to address any loss of vital assets or information |
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Independent
IECs to oversee ethical conduct of all studes |
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Protocols as per ICH guidelines |
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Informed consent of volunteers (In English and/or vernacular language) |
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SOP driven procedures |
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IQ/OQ/PQ of instruments |
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Validation of bioanalytical methods |
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Independent quality assurance |
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Meticulous and accurate recording and reporting of results |
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