How to make use of concomitant drug information in clinical trials: from WHODrug to relevant analysis and submission using the SDTM Standard
This webinar will cover the basics of WHODrug and how the information can be used to make relevant analysis in a clinical trial. We will discuss which data needs to be included in the CRF for the most efficient coding, resulting in less number of queries. We will also discuss how the WHODrug structure can be used to understand more about the individual patient, how to utilize concomitant drug information in efficacy analysis and effective identification of use of prohibited meds using Standardised or Customised Drug Groupings (SDGs or CDGs).
From this webinar, participants will understand what information on concomitant drugs is of importance for relevant and efficient analysis and coding in clinical trials.
- What data to collect on CRF to reduce number of queries related to drug coding.
- Understand how to use the WHODrug structure to find and group relevant data
- Understand how to use SDGs and CDGs for quick identification of protocol violations and deviations
- Identify key steps needed for a successful submission using the CDISC SDTM standard.
Who Should Attend
The audience for this training is coders, data managers and people responsible for analysis of concomitant medication. Beginner to intermediate level, audience with basic understanding of the CDISC SDTM standards will benefit more.
Meet the Presenters
Malin Jakobsson, Product Manager WHODrug, MSc pharm
Malin Jakobsson is Product Manager for the WHODrug product portfolio at Uppsala Monitoring Centre (UMC). She is a pharmacist by training and is responsible for new products, product developments and usability of existing products dictionaries to ensure the products meet the needs of the users. Malin is involved in global collaborations such as ISO and IDMP (IDentification of Medicinal Products) task forces as well as collaborations with PMDA and FDA CDER related to the recent announcement from the two authorities to require the use of WHODrug for concomitant medications in clinical trials.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after viewing the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.