The courses are held in Switzerland in the Vaudois or Bernese mountains, where concentrated working is balanced by healthy outdoor activities enhancing the team spirit.
Next dates:
April 11 and 12 2002
May 23 and 24 2002
June 20 and 21 2002
August 29 and 30 2002
Duration: 1.5 days
Costs: EUR 530.-- or CHF 800.--
Upon request, tailor-made courses can be arranged and given in the facilities
of either a Pharmaceutical Company or a Health Care environment, as appropriate.
For details and to apply, please contact:
info@clinville.com or angela.lopes@clinville.com
Curriculum:
THEORY
Basics:
Clinical Research & Development: goals, background, examples
GCP - Good Clinical Practice: rationale and goals
ICH – International Conference of Harmonisation : rationale and goals
SOP - Standard Operating Procedures: rationale and goals
Regulatory aspects in general
Ethics Committees
Institutional Review Boards
Confidentiality of patient data – Data protection law
Standard Research team:
Sponsor (Pharma Industry, Biotech Company, Medical Device Company; National Health Organisations)
CRO (Contract Research Organisation, Contract Lab)
Investigators
Patients
Study Documents:
Investigational Drug Brochure
Protocol
Patient Information – Informed Consent
Insurance coverage
Case Report Form
Contracts
Study performance:
Investigator selection and recruitment
Study Initiation
Monitoring and data clarification
Source Data Verification
Patient recruitment, patient logs
Drug accountability
Study termination
Analysis and reporting
Principles of coding
Rationale of standardisation
PRACTICAL PART (on 3 sample studies)
Planning:
Pre-screening and Selection of patients in electronic patient data
Information of Study Nurse and coordination of activities
Patient handling:
Patient selection
Informed Consent
Organisation of study schedule, optimisation of study compliance
Adverse events and serious adverse events
Optimisation of compliance to study medication
Data handling:
Data entry on an e-crf
Handling of data query
Handling of Source Data
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