Training Course & Event Calendar
Level Two Accredited Training Program in Clinical Data Management – Technical Skills
Course Date: June 26, 2018
Type of Course: Face to Face
Course Trainer: Cliona O’Donovan- Cliona 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 which this accredited program now builds on.liona 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 which this accredited program now builds on
Location of Course: Slough, Berkshire
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 (ICH GCP) 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 processes involved
Who is the Course Suitable For?
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.
The Technical Accredited Training Program in Clinical Data Management is aimed at further developing essential technical and applied clinical data management skills. The training courses are highly interactive and supported by comprehensive materials and evaluated course work.
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
Outline Course Content
Link for Booking: click here