ACTRIS – scenario 1, temperature excursion

The site monitor, during an on-site visit flags a temperature excursion has occurred the past week. This has not been reported yet to the team, and next week already, the IMP from that particular refrigerator needs to be dispensed to a newly enrolled trial participant.

After having collected the necessary information*, a new issue is created in ACTRIS, set to priority ‘high’ and to risk type ‘Project Risk – IMP/IP’, and assigned to the team member most knowledgeable and/or available**. A picture of the temperature graph is appended, alongside the telephone number of the local site Pharmacy representative. The site monitor next can resume his/her other work whilst visiting this site, and wait for feedback on the ACTRIS issue’s ‘comment’ field. Jira’s app can be used to keep an eye on the team’s feedback.

If advise is needed from a member outside of the team (with no access to ACTRIS), a PDF can be made within three mouse clicks, and this can be forwarded via e-mail.

In the Site Monitoring Report, this particular issue flagged is reported by using the hyperlink to its ACTRIS issue. This way, action items will be kept separate, yet integrated (eventually), avoiding duplication of efforts. Follow-up to the issue will be given to the issue itself, within the timelines specified for ‘high’ priority risks. There is no need to use e-mail when it gets to informing all in the team. The report reviewer will have a timely view on the issue at the moment of review***, by clicking on the link.

*to allow for a Root Cause Analysis

**a solution to team members working across time zones, and regions

***usually, the reviewer is the PM, who can add final comments to the issue, and next resolve and close it. Only the PM can close out issues, as per authorization level set on ACTRIS

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About S.I.C.

Smeets Independent Consultant - SIC, is the full name of my/Edgar's company, established in 2003. I am a sole trader, in the Netherlands known as 'ZZP'. The company is registered with the Chamber of Commerce (KvK) number: 39.08.30.34, and is VAT registered. I partner with (bio)pharmaceutical companies, start-ups, Institutions, investigators, or CROs to consult on and assist with a variety of tasks within the clinical research field. All my activities are performed using efficient reporting to my clients (risk-based, lean), and sustained by appropriate follow-up. I have a few SOPs in place myself to cover the topics 'Physical and Digital Security', and 'GDPR; Preventive and Corrective Measures', in my home office. You are kindly invited to explore this website, and please DO contact me with any questions.

Services offered

In general I offer a rather straightforward, efficient set of services when setting up your research project/trial, and represent my client when following through during the execution of the trial(s). I always keep a lean, business-like approach in mind.
The tasks performed by me could be one of the following, by itself or combined:
  • 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').

Contact

On request, I can send you further information, such as a Curriculum Vitae, a recent copy of my training log, a publication list, or my ACRP credentials. Please contact me to have a chat, and to find out my current or future availability.

e.smeets@sic-est.nl
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