ACDM Level Two Accredited Training Program 2016 - Clinical Data Management - Technical Skills
Webinar 1 (12:30 GMT / 75 mins): 29th April 2016
Webinar 2 (12:30 GMT / 75 mins): 13th May 2016
Webinar 3 (12:30 GMT / 75 mins): 27th May 2016
Webinar 4 (12:30 GMT / 75 mins): 10th June 2016
Webinar 5 (12:30 GMT / 75 mins): 1st July 2016
Face-To-Face Training Session (1 Day): 11th July 2016
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 Two Accredited Training Program in Clinical Data Management is aimed at developing technical 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 how to lead the technical data management activities on a clinical trial.
Explain the data management tasks to be performed from study set-up to close out.
Explain key considerations for data collection from various sources including clinical trial assessment visits, patient reported outcomes, electrocardiograph, laboratory data and imaging.
Describe mechanisms used to allocate tasks to the roles of the data management team.
Explain how to ensure data quality from the Case Report Form (CRF) design go-live to database lock.
Understand the reasons for transparency in clinical trial data management.
Describe the reasons for data transparency in clinical trial data management.
Compare and contrast the use of paper and electronic audit trails.
Explain access control to clinical trial information.
Understand how to integrate clinical study data with other important sources of clinical trial information in accordance with the International Conference on Harmonisation Good Clinical Practice (ICHGCP) principles.
Describe other eClinical tools (ePRO / clinical trial management systems / randomisation tools).
Explain how information from these systems is useful for clinical data management.
Evaluate strategies for managing version control challenges when working with classification systems such as the Medical Dictionary for Regulatory Activities (MedDRA).
Analyse the importance of computer system validation and the process involved.
This course is extended over 6 sessions from April through to July 2016 and comprises of 5, 75 minute webinars and 1 face-to-face session. 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. Practical exercises will include hands-on activities with an Electronic Data Capture (EDC) system.
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. Click here for more details
Click here for full course details and online booking
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