Pre-study Operations Visit Sample Clauses

Pre-study Operations Visit. ‌ On a study-by-study basis, a pre-study operations visit may take place. Following the pre-study site assessment visit, and after a study protocol is finalized and draft study CRFs have been approved by the protocol team, the LOC CRM, LC and SDMC PM may conduct pre-study operations visits with at least one participating study site. This is part of the process for finalizing the study CRFs and SSP Manual (described in Section 10.5 and 10.7, respectively). Depending on the needs of the study, multiple visits may be conducted. Every effort will be made to involve key study implementation staff from sites in the visits. For some studies, visits may be conducted at each participating study site. For other studies, a single visit may be conducted, and key staff from other sites asked to attend the visit. The purpose of pre-study operations visits is to obtain detailed site input on both day-to- day study implementation tasks and activities and the content of the study CRFs. The visits take place over several days and may include a step-by-step “walkthrough” (time permitting) of the protocol specifications for each study visit and the CRFs completed at each visit. Source documentation requirements associated with each study procedure also are discussed. Input received from site staff is incorporated by the LOC CRM and SDMC PM into the draft study SSP manual and the study CRFs set, such that a form set reflecting all required site input can be finalized prior to conduct of study-specific training. Following the visit, the LOC, LC and SDMC staff member will generate a visit report and distributes it to the site investigators, DAIDS, and the other Network entities, as appropriate. The LOC CRM, LC representative and SDMC PM will work with the site staff to address any issues raised by the visit(s) and documented in the visit report(s).
Sample 1
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Related to Pre-study Operations Visit

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  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

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  • Synchronization, Commissioning and Commercial Operation 4.1.1 The Power Producer shall give at least thirty (30) days written notice to the SLDC and GUVNL, of the date on which it intends to synchronize the Power Project to the Grid System.

  • Synchronisation Commissioning and Commercial Operation 8.1 The Developer shall provide at least forty (40) days advanced preliminary written notice and at least twenty (20) days advanced final written notice to ESCOM of the date on which it intends to synchronize the Power Project to the Grid System.

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  • PROFESSIONAL DEVELOPMENT AND EDUCATIONAL IMPROVEMENT A. The Board agrees to implement the following:

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