Clinical monitoring: a senior CRA for reliable data
A Clinical Research Associate since 2000, I give sponsors rigorous oversight of their sites, from phase I to phase IV, in line with the protocol, procedures and source documents.
What I take care of
- Site selection, initiation, monitoring and close-out visits, on site or remote, as defined in the monitoring plan.
- Informed consent and eligibility review.
- Source data verification and review (SDV/SDR) against the eCRF, query management.
- Serious adverse event follow-up and timely reporting checks.
- Investigational product accountability: receipt, storage, dispensing, traceability, returns.
- Investigator site file (ISF) maintenance and TMF contribution.
- Visit reports and follow-up letters, tracker updates.
- Financial agreement and investigator payment follow-up.
- Escalation of site issues and improvement proposals with the project team.
Frequently asked questions
What sponsors, CROs and sites most often ask me before a mission starts.
Do you do remote monitoring?
Yes. I combine on-site visits and remote monitoring (centralised review, eSource, eISF) according to the monitoring plan and the ICH E6(R3) risk-based approach.
Which eCRF systems have you used?
Medidata Rave, InForm, RDE, Clinfile, Catchtrial, PPD Preclarus, plus vendor portals such as Clario, Almac, Covance or Imagys.
Need help with this?
Leave your details and a few words about your study: I will get back to you within 2 business days.