ACTRIS – scenario 4, using filters to stay ‘on top’ of things

The use of boards and filters in ACTRIS is a great way to stay on top of things, keeping outside stake holders informed, and show one’s involvement*. Two scenario’s here below to make my point.

Working with a team and distributed work; a team member involved as consultant IMP and GMP specialist** can only work on Tuesdays. Rather than going over his entire e-mail inbox on Tuesday morning to find relevant messages/issues for his input, a filter is made on ACTRIS. The filter will select all items dealing with IMP, of any status (in progress, closed, or resolved) of any priority. A subscription is made as well, telling ACTRIS to e-mail the filter’s result to him on each Tuesday at 08:30 hr sharp. In the e-mail overview, the specialist can click on either hyperlinked issue to get to work.

Every second Thursday morning of the month, the PM will convene with the wider project team. The project team will go over any open issues, among other things. To this end, a filter is made listing all ACTRIS issues with status ‘in progress’. The resulting issues can be shown via the projector, or can be compiled in one PDF file to be forwarded shortly before the meeting. Comments from the project team can be entered with the issue and used to each issue’s follow-up, or the issue can be resolved by team decision/vetting, etc.

See next page.

*Without doubt, the filtering and subscription functionalities are SIC’s favorites. SIC will assist any new client with creating a basic set of filters, so to get this fire started in your team too

**new high priority issues dealing with IMP created in ACTRIS will be assigned to him as per agreements, so he will be alerted on these via e-mail in any case

Services offered

Selecting sites for your research project, preparing each, setting up the logistics, contracts, and applying for regulatory approvals (EC and CA)

Central Monitoring, with on-site visits where needed (in line with Risk-based Monitoring approach) (Quality Control)

Quality Assurance when setting up your research project, build or refresh your Quality Management System (issue Monitoring Plan, Data Management Plan, etc.)

Data Management activities / (extended) Central Monitoring

Employ ACTRIS (see elsewhere) to manage any issues / potential risks

Train or coach other CRAs/monitors working on the same trial

Oversee Safety Reporting, provide follow-up if needed

Generally speaking, all the tasks described under item 5.18 of the E6 ICH-GCP guideline

In general, when submitting your trial to EudraCT, my name and details will get listed at section G5 of 'Annex 1 Clinical trial Application Form' (G5 sub items 1.9, 1.10, 1.11 and 1.13 answered 'yes').