On-site monitoring of a complex source file
Complex therapeutic trial with amendment, long patient follow-up, multiple study procedures, complex medical history, numerous adverse events and concomitant treatments, fraud.
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, suspected fraud.
- 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.
- Notification of suspected fraud.
Programme 2
Ethics and consent
- Qualification and legitimacy of the person collecting informed consent ;
- Respect for patients' rights: information, time limits (reflection period, post-consent research procedures), immediate information on any new development, right of refusal or withdrawal;
- Version and completeness of consents.
Data confidentiality
- 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.
Proposed solutions
- Investigation of discrepancies ;
- Communication with the investigating centre on complex issues.
Good Clinical Practice
- Qualification and legitimacy of the persons carrying out the procedures in the research protocol ;
- Compliance with the research protocol and its amendments, patient eligibility criteria, research procedures including the administration of trial products;
- Quality of source documents, ALCOA (attributable, legible, contemporary, original, reliable and complete)
- Timing and completeness of serious adverse events.
Writing up discrepancies
- 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 experienced ARCs 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 complex source file training programme, our methodology and its objectives.
