ACTRIS – enabling efficient reporting

Use of ACTRIS not only provides a few great avenues to keep the overview (such as the basic board, the first user screen when logging in from a regular browser, or the summary), it also allows for adoption of a lean way of reporting.

For this to happen, all team member should make effective use of ACTRIS, and should acknowledge:

that the management of issues will occur outside of the (usual) standard reporting methods, in ACTRIS itself
the use of e-mail messages to deal with issues in any way, is to be avoided
the person assigned to the issue, ‘owns’ the issue and takes care of its sound resolution
only the Project Manager can ‘close‘ an issue, if (s)he agrees to the information collected, the decisions made etc.

Next, team members can use the hyperlinks to the issue(s) they want to report on in other means. This way, all information is in one place, safe, easily to be found and accessible to each (no need anymore to spend time finding a specific e-mail message in your extensive inbox, dealing with a similar issue a few weeks back..). Team members can learn from (the resolutions provided to) previous issues, trends analyses can be applied.

The ACTRIS add-on ‘Better PDF Exporter‘ can be used at all times to create a PDF file with all of the issue’s information, including the attachments, and the full audit trail.

SIC, as part of the Service Level Agreement, shall provide two ‘templates’ the Client may use for their ‘Remote Monitoring Visit Report*’ and ‘On-site Monitoring Visit Report’.

*As per ICH-GCP E6 R2 guideline, reports of centralized (remote) monitoring actions should be provided to the study sponsor for review and follow up (see 5.18.6.e).

See next page.

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').