site initiation visit presentation template

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the site initiation visit (siv) is required to prepare and set up a research site to conduct a study and must occur prior to patient recruitment.  the principal investigator (pi) must attend this visit together with as many members of the research team as possible. representatives from any supporting departments should also attend where possible e.g. pharmacy, radiology, laboratories. the role of this meeting is to discuss the protocol, especially the inclusion/exclusion criteria,study procedures,  and the research participant pathway the sponsor will discuss  the monitoring plan for the study – including safety reporting procedures and monitoring to good clinical practice (gcp) and international conference on harmonisation (ich) requirements.

the study initiation visit may be held prior to irb approval, arrival of a. template agenda for site initiation visit stipulations for scientific publications and presentations at professional meetings. i.e. 23 months. •follow-up finish – feb 2019. •sample size – 330. •number of uk sites – at least 22 site initiation visit (siv) guidance it is recommended that the sponsor sends the template agenda to their contact at the site for the siv as required i.e. delegation logs, training logs, presentation., site initiation visit checklist, site initiation visit checklist, remote site initiation visit, site initiation visit attendance log, siv training log.

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