Collecting accurate scientific data is essential in clinical trials to ensure the safety of trial participants and the
efficacy of the drug during the development phase. Even with the rapid development of science and technology, on-site Source Data Verification (SDV) is still the most important and reliable method of ensuring data integrity. By checking the quality of the source documentation, SDV helps to detect and resolve issues at the very beginning. To maximize the SDV effect and provide critical support to the site, a CRA should also be able to trace back to verify the source data (SDR - Source Data Review). This SDV Workshop for CRAs is based on PAREXEL’s 30 years of clinical trial experience and a large number of case studies. You will learn about the practical skills of SDV and SDR through numerous exercises. To enable you to verify that the study data is in compliance with international requirements, the Workshop also covers designing an SDV strategy and tools and updating them during monitoring activities.
- SDV and related regulations
- Critical data, critical documents review
- Methodology for a logical SDV
- Design of an SDV strategy and tools and updating them during monitoring activities
- Efficient communication plan to enhance clinical site data quality
- Understand regulations and requirements of SDV
- Define critical data and learning methodologies for a logical SDV
- Design an SDV strategy and tools and update them during monitoring activities
- Communicate effectively with sites and follow-up SDV findings
Source documents and logical SDV:
CRAs will be instructed how to review relevant SDV points of each core document. Course participants will be able to apply three unique skills to conduct a logical SDV to ensure that the data across documents is realistic and consistent. During the session, we will focus on the CRAs’ observational ability and logical thinking ability.
SDV strategy and SDV tools:
SDV is the method used for detecting any issues with site data and resolving these issues at source. A CRA at site
can identify any deficiency of SDV strategies or related SDV tools and feedback accordingly to the project team.
Therefore knowing how to design the SDV strategy can improve the quality of data. During the course participants can practice how to design an SDV strategy based on sample cases and to use this strategy to simulate and find problems.
Communication is the key:
Communication is the key success factor for an effective SDV. Detecting an issue is the first step; just as important is communicating the correction plan to the site appropriately. In this workshop participants will learn how to create a well-structured communication plan to support investigational sites and to gain a better result from audits and inspections.