Study-specific Preparatory, Assessment Sample Clauses

Study-specific Preparatory, Assessment and Initiation Visits to Sites Prior to initiation of an HPTN study, site readiness for study implementation must be ascertained. The LOC, SDMC, LC, Clinical Site Monitor, and DAIDS may conduct visits if needed to assist sites in preparation and to assess and confirm readiness to undertake a specific study. These visits will likely include a combination of the visits described in the following sections. The table below summarizes these visits. The timing of these visits will be planned with the site investigator and staff to allow participation of key site study staff. Table 10-2 HPTN Pre-study Site Visits Pre-study Site Visits (typically conducted for sites previously not in HPTN) Type of Visit Purpose Timing / Requirements Responsible Group(s) Pre-study assessment (Section 10.3.1) To assess site infrastructure, operations, and staffing Prior to acceptance as a participating site, and prior to finalization of protocol LOC, SDMC, LC, and/or DAIDS Pre-study operations (Section 10.3.2) To obtain site input on day- to-day study implementation and content of study CRFs; to review source document requirements for each procedure Following finalization of protocol, when draft CRFs and SSP manual are available, and prior to study-specific training LOC, SDMC, LC Special assignment study- specific initiation (Section 10.3) To be specified in advance by DAIDS/Clinical Site Monitor Following IRB/EC approval of protocol and prior to study training. See the table in Section 11.4.2 Lab and/ or Clinical Site Monitor Protocol Training (Section 11) To participate, as trainers and representatives of the central operations components, in study- specific training Following Clinical Site Monitor initiation visit (if applicable as determined by OCSO). See the table in Section 11.4.2 for a list of specific requirements LOC, SDMC, LC and any experts/ consultants as applicable
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Related to Study-specific Preparatory, Assessment

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