Training Course & Event Calendar
Level One Accredited Training Program in Clinical Data Management – Fundamental Skills
Course Date: March 21, 2018
Type of Course: Face to Face
Course Trainer: Jon Wood
Location of Course: Maidenhead, UK
Learning Objectives:
Understand the clinical trial process –delegates will be able to:
- Explain the clinical trial process including the purpose of the clinical trial protocol, statistical analysis plan and clinical study report
- Describe the typical study team roles and responsibilities in a clinical trial
Understand the role of the data management function within the clinical trial process:
- Describe the purpose of the Data Management Plan
- Explain the aims of data validation
- Describe different types of database lock and their appropriate use
Know how clinical research is regulated:
- Explain the key elements of the International Conference on Harmonisation of Good Clinical Practice (ICH GCP)
- Explain the purpose of the regulatory bodies in Europe, USA and Japan
- Explain the purpose of SOPs
Understand how to deliver high quality clinical data for analysis:
- Describe a suite of data validation checks for a sample study
- Explain how a manual data query could be resolved by the responder on the first attempt
- Explain the purpose of coding clinical data with the medical Dictionary for Regulatory Activities (MedDRA)
Who is the Course Suitable For?
The ACDM Accredited Courses in Clinical Data Management deliver a solid foundation in clinical data management skills starting with core fundamentals, progressing to technical and advanced skills through to project leadership, empowering professional Clinical Data Managers and enabling them to develop their career path in the pharmaceutical industry.
The Level One Accredited Training Program in Clinical Data Management is aimed at developing essential core clinical data management skills. The training courses are highly interactive and supported by comprehensive materials and evaluated course work. This course is run on two consecutive days, as Face-To-Face sessions. Comprehensive course materials are provided and delegates will be expected to successfully complete pre and post-course work in order to complete the accredited program
This course is aimed at new colleagues or individuals involved in other areas of clinical research looking for a comprehensive overview of the management of clinical data.
Outline Course Content
Regulators are increasingly requesting evidence of competence. Experience alone does not provide evidence of competence. The ACDM, in partnership with the International Academy of Clinical Research, has developed a series of training programs supported by comprehensive course work and interactive sessions, providing independently recognized, competence-based accreditation to support the continued professional development of staff involved in the management of clinical trial data.
Link for Booking: click here