Coding in clinical trials allows for the collection of conceptually consistent information and the management of controlled data. Coding depends on information standards such as MedDRA, WHO Drug and CTCAE. This webinar will review common information standards used in clinical research and then discuss implementation and management of these coding standards. Coding dictionaries are examples of information standards used in clinical research. The first part of this webinar will review common coding dictionaries. The background of selected coding dictionaries, their content, organization and capabilities will be reviewed. The topics in the second part of this webinar will include validation, implementation, usage, and change control from version to version of these coding dictionaries.
What You’ll Learn
Attendees will be able to:
1. Identify common coding standards used in clinical trials.
2. Describe the content, organization and capabilities of selected coding standards.
3. Describe the validation of coding standards.
4. Explain the usage of selected coding standards.
5. Explain change control for different versions of coding standards.
This webinar will introduce common coding standards and explain the use of these coding standards. Coding dictionaries will provide the examples for validation, implementation and version control.
Elmarie Heennop graduated with the following qualifications: B.Soc.Sc Nursing (1998). Since joining Quintiles in 2005 she has gained vast experience in trials as Coder, Medical Coding Reviewer and Associate Manager in various therapeutic areas (phase I - III). Responsibilities have spanned the full duration of studies, from start-up to project close-out and review. She is currently managing a professional Data Management team (10-20) which are involved with Coding, Medical Review, SAE Reconciliation and Lab Data Management. The responsibilities of this position include providing leadership and comprehensive data management expertise to a data management team; planning, assigning and directing work, ensuring the delivery of quality data management products that meet customer needs.
Sanet Olivier, CCDM, Director Global Data and Safety Monitoring at Quintiles, recently moved to a new role as Director: Customer Relations. Sanet’s overall experience relates to more than 18 years in Clinical Research with more than 13 years in Data Management. Her career developed from Lead Data Manager (LDM) in large multi-national studies (Phase 1, 2 and 3) across Europe, South Africa, Australia, Asia and USA, to Group Manager, Associate Director (CDM), eData Technical Specialist (Global EDC) and until recently as FSP Director. Sanet has gained significant experience working in several therapeutic areas and she has extensive experience across various platforms and systems including all of the major commercial platforms.
Who Should Attend
Beginners to intermediate CDMs, CRAs and biostatisticians.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline. Each part of this 2 part webinar carries 0.2 CEUs.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.