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On-site monitoring of a single source file

Simple therapeutic trial, short patient follow-up, limited study procedures, simple medical history, minimal adverse events and few concomitant treatments.

More than 20 h training courses

Identify non-compliance with the regulatory framework

- Ethics and consent, Declaration of Helsinki.
- Good Clinical Practice.
- Data privacy, General Data Protection Regulation, GDPR

Drafting monitoring observations

- Discrimination of deviations, queries, minor or major deviations.
- Justification for deviations and reference framework used to qualify the deviation.

Define an appropriate action plan

- Clarifications requested from the investigating centre.
- Actions proposed to the investigating centre to prevent recurrences.

Programme 1

  • Qualification and legitimacy of the person collecting the consent ;
  • Respect for patients' rights: information, time limits (reflection period, post-consent research procedures), right of refusal ;
  • Version and completeness of consent
  • Protection of sensitive data, correspondence list between patient identity and identification in the protocol ;
  • No disclosure or leakage of patient or health professional's personal data.
  • Investigation of discrepancies ;
  • Communicating with the investigative site about common problems.
  • Qualification and legitimacy of the persons carrying out the procedures in the research protocol ;
  • Compliance with the research protocol, patient eligibility criteria and research procedures, including the administration of trial products;
  • Quality of source documents, ALCOA (attributable, legible, contemporary, original, reliable and complete)
  • Summary description of events observed ;
  • Designation of the standard used to qualify the deviation, Good Clinical Practice, Declaration of Helsinki, RGPD.

Need more information?

You want to develop the business skills of your junior CRAs within your company.
You're looking for a relevant training program that combines a paperless tool with one-to-one support from an experienced trainer.
Contact us for more information about our On-site Monitoring of a Simple Source File training program, our methodology and its objectives.

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