Site Checklist for NCCIH Initiation Visit Scheduling/Logistics Query PI and relevant study staff regarding the monitor’s proposed visit dates Confirm mutually-agreeable visit date with the monitor and study staff Reserve meeting room, computer, projector, screen, and teleconference line, as needed Reserve work for the monitor Provide logistics information to the monitor for visit day: directions to site/room, time to meet, emergency contact/backup number as requested Notes: Preparing the Agenda Review the draft initiation visit agenda provided by the monitor, and make necessary modifications to reflect the specifics of the protocol and study team Identify and confirm which staff will be presenters and/or facilitators during the meeting Determine a due date for presenters to submit slides, talking points, or handouts, as applicable Finalize the agenda and all presentation materials to the visit date Meeting Materials Identify if meeting materials will be needed for the initiation For example, would meeting participants benefit from a copy of the final protocol, final CRFs, other documents, and/or copies of slides from presenters during the discussion? Determine if meeting materials will be distributed in hardcopy or electronically, and when Prepare and distribute meeting materials per plan Notes: Regulatory/Essential Documents NCCIH approval of protocol, CRFs, ICF, and DSMP File visit confirmation letter received from the monitor with the regulatory/essential documents Per the NCCIH regulatory summary sheet and checklist at , all required IRB and NCCIH approvals, documents of staff qualification and training, lab certifications, tracking and other logs are complete, up to date, and organized for review Notes: Study Data Confirm that source documents, CRFs, and database are finalized and available for review and discussion Notes: Post-Visit Follow-up
Site Checklist for NCCIH Initiation Visit Scheduling/Logistics Query PI and relevant study staff regarding the monitor’s proposed visit dates Confirm mutually-agreeable visit date with the monitor and study staff Reserve meeting room, computer, projector, screen, and teleconference line, as needed Reserve work for the monitor Provide logistics information to the monitor for visit day: directions to site/room, time to meet, emergency contact/backup number as requested Notes: Preparing the Agenda Review the draft initiation visit agenda provided by the monitor, and make necessary modifications to reflect the specifics of the protocol and study team Identify and confirm which staff will be presenters and/or facilitators during the meeting Determine a due date for presenters to submit slides, talking points, or handouts, as applicable Finalize the agenda and all presentation materials to the visit date Meeting Materials Identify if meeting materials will be needed for the initiation For example, would meeting participants benefit from a copy of the final protocol, final CRFs, other documents, and/or copies of slides from presenters during the discussion? Determine if meeting materials will be distributed in hardcopy or electronically, and when Prepare and distribute meeting materials per plan Notes: Regulatory/Essential Documents NCCIH approval of protocol, CRFs, ICF, and DSMP File visit confirmation letter received from the monitor with the regulatory/essential documents Per the NCCIH regulatory summary sheet and checklist at , all required IRB and NCCIH approvals, documents of staff qualification and training, lab certifications, tracking and other logs are complete, up to date, and organized for review Notes: Study Data Confirm that source documents, CRFs, and database are finalized and available for review and discussion Notes: Post-Visit Follow-up
Initiation_Checklist_07-17-2015.docx