This clinical trial documentation training will cover best practices in writing clinical data queries, regulatory guidelines, the pitfalls and challenges. It will help you understand how clinical trial documentation affects the data query process and explain steps to ensure smooth implementation of the clinical data query process.
Why Should You Attend:
Efficient querying of clinical data is a critical step in the data collection process leading to establishment and maintenance of the clinical trial database. This webinar will help you understand and implement the data query process.
This presentation will provide an overview of the Clinical Data Query process, referencing the roles of key clinical/ medical reviewers and data management personnel.
We will discuss how the following clinical trial documentation impacts the data query process:
a. The clinical protocol
b. Case report form design and use
c. Data query requirements
Associated with this documentation, we will also discuss the following operational considerations:
a. Query of portions of the clinical data
b. Query of selected patients
c. Scheduling and timing of data query process
d. Resources needed for data query process
e.Incorporation and validation of queried data
f. Auditing of data query process
Additionally, examples of the challenges in the data query process and suggested remediation practices will be provided.
Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702774?channel=yahooevent
Added by complianceonlinecom on March 7, 2013