ACTRIS – scenario 2, eCRF review shows protocol deviation

The monitor, during remote eCRF review (as per the Monitoring Plan) flags a (potential) protocol deviation. She/he phones with site staff to ask for clarity, and obtains conformation. Sadly, this is not an isolated case. This particular site is not organized very well.

After having collected the necessary information*, a new issue is created in ACTRIS, set to priority ‘medium’ and to risk type ‘Project Risk – Data Validity’, and assigned to the PM. The issue is linked to previous issues identified at this site.

In the Remote 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 ‘medium’ 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.

*including a screenshot from the eCRF, and any other details to assist in the analysis of this deviation

**it can be commented on, resolved and closed. It can easily be filtered out of all issues on ACTRIS, taken for training purposes, for collection onto Protocol Deviation Logs, etc.

See next page.

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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