Links

For further information / interesting links, please see below.

www.ccmo.nl
In the Netherlands, the Central Committee on Research Involving Human Subjects (CCMO) oversees the operations of accredited Ethics Committees (ECs) (e.g. the approval of appointed EC members, their training requirements and ensuring implementation of adequate quality control measures). The CCMO is also responsible for keeping track of all clinical trial applications reviewed in the Netherlands since 1999. 

This register adds to the transparency for all involved, and any person with slightly more than layman’s knowledge could quite easily find particular trials (active or non-active) matching an indication of their interest.

It contains lots of information on what to submit to which body, and how.

The CCMO website is available in English as well.

I am a member of the following organisations:

www.acrpnet.org  –  Association of Clinical Research Professionals

www.icr-global.org  –  The Institute of Clinical Research

www.darqa.nl –  Dutch Association for Research Quality Assurance

www.efgcp.eu  –  European Federation of Good Clinical Practice

In addition, the following two sites offer good information and training.

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 (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, my ACRP credentials, or my current or future availability.

e.smeets@sic-est.nl
© 2020 Smeets Independent Consultant.