Continuous site monitoring
Remote verification of the conduct of biomedical research without access to the source file and management of the investigative site between site visits.
More than 20 h training courses
Identify non-compliance with the regulatory framework remotely
- 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 correct discrepancies.
- Actions proposed to the investigating centre to prevent recurrences.
Programme 3
Good Clinical Practice
- Investigator supervision ;
- Qualification and legitimacy of the persons carrying out the procedures of the protocol and its amendments;
- Provision of laboratory tests and results to promoters or subcontractors ;
- Entering data in the observation book ;
- Consistency between databases (observation book and subcontractors) ;
- 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.
Data confidentiality
- Agreement for the use of caregivers' personal data ;
- No disclosure or leakage of patient or health professional's personal data.
Action plan before returning to site
- Adaptation to the centre's operations and targeting of the manager concerned by the action ;
- Validation of a correction schedule by the project manager ;
- Review of actions underway at the centre ;
- Closure of the actions carried out and updating of the action plan.
Need more information?
You want to develop the business skills of your senior 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 Continuous Site Monitoring training programme, our methodology and objectives.
