Continuous monitoring of site
Remote verification of the conduct of biomedical research without access to the source file and management of the investigative site between site visits.
Requirements
Documentation of of 5 years of professional experience as a Clinical Research Associate
Validation of program 2 On-site monitoring of a complex source file
Professional English (CV)
Equipment to attend the training (computer and internet connection)
E-learning 36 h training over 4 weeks
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.
Program 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.
Further information
Assessment procedures Throughout the course, skills are assessed by means of work situations in a virtual environment. Subject to skills validation, a training certificate is issued to trainees
Terms and conditions to access Access to the e-learning platform is granted according to schedule defined the signed training agreement and first payment executed.
Disability The training is adapted for people with disabilities.
Action Site is a training organisation that is a member of theAFCROs and benefits from a legal and regulatory intelligence on training content, skills, professions and jobs in the sector
Cost of each program
Individual price €1,080 incl. VAT - Company price €1,296 incl. VAT