How to prepare for Site initiation visit?
SIV preparation is a comprehensive, methodical process to ensure the most effective SIV conduct. These tips will help facilitate the process:
1. Read and confirm the exact process for SIV conduct from the monitoring plan. The monitoring plan should detail all visit aspects: systems utilized (EDC, ePRO, lab portals, central imaging vendors), protocol elements for review, investigator site file instructions, IP receipt, temperature monitoring, inventory, and confirmation instructions.
2. Stay apprised of site activation status.
3. Ensure the PI, and study coordinator/site staff are aware of any ancillary site staff that need to attend the SIV (pharmacy staff, raters, sub investigators).
4. Prepare an agenda detailing topics/categories/tasks for review/completion, time periods for each activity and whom from the site is required to attend. Organize timing and planning with the study coordinator so they can plan accordingly.
Construct an adaptable agenda as unexpected changes may occur, and you will need to accommodate. Flexibility is key!
5. Send required documents for site completion in advance of the visit. This will save everyone time and ensure at least some can be collected at the visit.
6. Track supply shipments and site receipt (lab kits, investigator site file, ePRO devices, IP, etc.), for inventory at the SIV. Check with the site before the visit regarding receipt or notification.
7. Check site staff systems access to EDC, IVRS, SIP-whatever platforms are being used. Be sure to provide help desk information.
8. Prepare an abbreviated PI SIV presentation-just in case. Mark the slides and information required for PI review. Unexpected things happen and you may have a shorter amount of time with the PI to review protocol/study information.
You can review the remaining information with site staff during the visit.
9. If a sponsor representative is attending, be sure to liaise with them and provide them with the agenda, directions to the site and relevant information.
10. Bring printed copies of slides/material and ensure you have sent the slides and protocol to the site before the visit.
11. Arrive to the SIV early enough to allow for AV set up. The site may have a large monitor/screen that they want you to use for the protocol presentation to accommodate a large audience.
If for some reason your laptop cannot connect successfully with their equipment, ensure you have brought a secondary monitor to compensate for this viewing.