to be confirmed - Heathrow / London Area
Level One Accredited Training Program
Clinical Data Management - Fundamental Skills
Course Dates: 18th & 19th January 2017 - Face to Face Training Session (Venue TBC, Heathrow/London Area)
Course Overview - Why Should you Attend?
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.
Continuing Professional Development (CPD) is a way for professionals to demonstrate that they continue to learn and develop throughout their careers, to keep their skills and knowledge up to date and are able to work competently.
CPD points are related to the notional learning hours in taking a course and include any learning hours spent on pre-course work and any post-course work. The latter includes collecting the learning evidence on the job and taking part in the assessment process.
Each of the ACDM’s courses has been assigned a number of CPD points based on the time involved in participating in the course and in completing assigned pre- and post-course work.
The courses are quality assured by bodies regulated by Ofqual (Office for Qualifications and Examinations Regulation) and the levels are recognized within the ISCED framework (International Standard of Education) framework produced by UNESCO (United Nations Educational, Scientific and Cultural Organization).
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.
Who should attend?
This course is aimed at data management professionals who have some hands-on experience across data management or are new to the data management role.
Course learning objectives
Understand the clinical trial process
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)
This course is run on two consecutive days on 18th & 19th January 2017, 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.
Cliona O’Donovan gained her first degree in Pharmacology, and has a Masters in Epidemiology. She has over 20 year’s data management experience in clinical trials, and in handling data across all phases of clinical research and across many therapeutic areas. Cliona has run many successful training courses for the ACDM over previous years including Fundamentals of Clinical Data Management which this accredited program now builds on.
Training Course Participation is £1950 plus VAT for ACDM members (£2319 plus VAT for non-members).
Accommodation is not included in the delegate fee and will need to be arranged by attendees if required.
We look forward to seeing you at this exciting training course!
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