| 1 | 1 | Project Management | | | |
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| 2 | 1.1 | Develop Project Management Plan | item1 | 1 | Nos |
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| 3 | 1.2 | Develop study monitoring plan | item2 | 1 | Nos |
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| 4 | 1.3 | Develop monitoring report system | item3 | 1 | Nos |
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| 5 | 1.4 | Development of auto-tracking tools | item4 | 1 | Nos |
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| 6 | 1.5 | Maintenance of tracking tools | item5 | 1 | Nos |
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| 7 | 1.6 | Provide oversight team | item6 | 1 | Nos |
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| 8 | 1.7 | Support query resolution between the central data management team and site team | item7 | 1 | Nos |
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| 9 | 2 | Study Initiation | | | |
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| 10 | 2.1 | Site preparation | item8 | 1 | Nos |
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| 11 | 2.2 | Set-up study master file | item9 | 1 | Nos |
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| 12 | 2.3 | Organization of Site Initiation visits, facilitate travel and report generation | item10 | 1 | Nos |
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| 13 | 2.4 | Site Initiation meetings | item11 | 1 | Nos |
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| 14 | 3 | Site Monitoring | | | |
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| 15 | 3.01 | Routine, periodic & for call Site Monitoring | item12 | 1 | Nos |
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| 16 | 3.02 | Undertake source document verification through site visits, so that complete verification is done | item13 | 1 | Nos |
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| 17 | 3.03 | Consent form review as per ICMR ethical guidelines and CDSCO guidelines | item14 | 1 | Nos |
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| 18 | 3.04 | Review of Investigational Product records and accountability | item15 | 1 | Nos |
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| 19 | 3.05 | Help in shipment of investigational product to the sites including maintenance of cold chain and other required conditions | item16 | 1 | Nos |
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| 20 | 3.06 | Verify site compliance to protocol and GCP requirements, including continuing ethics committee requirements | item17 | 1 | Nos |
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| 21 | 3.07 | Pharmacovigilance monitoring including the reporting to appropriate regulatory authorities | item18 | 1 | Nos |
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| 22 | 3.08 | Provide MEDRA coding support for safety data (SAE/ NE) | item19 | 1 | Nos |
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| 23 | 3.09 | SAE review and helping the investigator with respect to causality and compensation | item20 | 1 | Nos |
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| 24 | 3.1 | Review of SAE reporting timeline as per applicable regulatory requirement | item21 | 1 | Nos |
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| 25 | 3.11 | Monitoring Reports | item22 | 1 | Nos |
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| 26 | 3.12 | Facilitate Site preparation for any other monitoring by the sponsor, audit or inspections | item23 | 1 | Nos |
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| 27 | 4 | Supply Management | | | |
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| 28 | 4.1 | Site Supplies Management (check supplies requirement including the kits) | item24 | 1 | Nos |
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| 29 | 4.2 | IP management (Check the requirement of IP at the site and its storage) | item25 | 1 | Nos |
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| 30 | 4.3 | Ensure appropriate pharmacy conditions including temperature recording, specimen / IMP tranfer with appropriate temperature maintenance | item26 | 1 | Nos |
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| 31 | 5 | Study Close out activities | | | |
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| 32 | 5.1 | Support for final archival of the study documents | item27 | 1 | Nos |
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| 33 | 5.2 | Study Close Out Report | item28 | 1 | Nos |
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| 34 | 6 | Training | | | |
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| 35 | 6.1 | Training of the study team members in ICH GCP and ICMR/CDSCO guidelines relevant to the study | item29 | 1 | Nos |
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| 36 | 6.2 | Training of the study team members in protocol | item30 | 1 | Nos |
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| 37 | 7 | Logistics | | | |
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| 38 | 7.1 | Preparation and Maintenance of Site Master File | item31 | 1 | Nos |
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| 39 | 7.2 | Preparation and Maintenance of Trial Master File | item32 | 1 | Nos |
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| 40 | 7.3 | Printing of ICFs | item33 | 1 | Nos |
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| 41 | 7.4 | Printing of CRFs, Diary cards | item34 | 1 | Nos |
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| 42 | 7.5 | Preparation of participant Binders | item35 | 1 | Nos |
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| 43 | 7.6 | Distribution/Delivery and Maintenance of all study related documents in/ to respective sites in timely manner. | item36 | 1 | Nos |
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| 44 | 8 | Applicable GST | item37 | 1 | Nos |
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