ACTRIS – scenario 3, track team training on new Lab Manual

The trial team issued a new Lab Manual incorporating recent changes to the central laboratory procedures (resulting in new trial sample kits plus acquisition forms). It was forwarded to all in the trial team, and all relevant parties at the sites*. To document receipt and ‘read plus understand’ in the team itself, ACTRIS can be used. Any items left not clear can be voiced and answered. Next, the issue can also be used to collect new comments to for a future version.

A new issue is created in ACTRIS, set to ‘risk’ type ‘Project – Improvement’, and assigned to nobody in particular. The new Manual is appended to the issue, or forwarded to each via e-mail. The issue’s hyperlink is forwarded via (a separate) e-mail to all involved, asking to review and to leave a comment such as ‘I read and understand’. Questions and comments can be collected the same way. No only can the team track this training effort in ACTRIS, its extensive audit trail serves as the documentation.

*In the current set-up of ACTRIS, no persons at the site level have been appointed to team member (my personal experience; site staff usually have other things to do). However, as per team decision, site monitors could obtain the training logs / AORs and append each with the issue, or simply comment for what site staff it is in place.

See next page.