In the previous post, I talked about varying levels of scrutiny for data review and what happens when recording the user actions. In this post, I will talk about the importance of the user interface for a review. Successfully navigating requirements, design, development, testing, user acceptance and ongoing support of any application requires user involvement […]
Posts Tagged ‘clinical study data’
Recording Review Actions During A Clinical Data Review
As was mentioned in a previous post, providing an easy-to-use interface is important for data review, including filtering, audit data, and User Review Action buttons. The user actions buttons initiate recording that all, or a portion, of a review has been performed. In the previous section, we mentioned a Review Timestamp, which is one of […]
Identifying Which Data To Review During A Clinical Data Review
In my last blog post, I presented some thoughts on showing data changed since last review. Today, we will concentrate on the level of scrutiny and what happens when recording the user actions in the review. Not all data may require the same level of scrutiny during a review. Additional focus may need to be […]
Identifying New Or Changed Data During A Clinical Data Review
In my previous post, we discussed some examples of business rules that might be applied depending on how many people are performing a clinical data review. Today, we’ll discuss approaches for selecting the data that is being reviewed. In any data review that occurs multiple times during the course of a study there are two […]
Are These Design Elements On Your List For Clinical Data Review?
In a few of my previous blog posts (4 Ways You Can Improve The Clinical Data Review Process and Using On-demand Data With Dynamic Data Writeback In Spotfire), I discussed using Spotfire as an aid for Clinical Review of data along with supporting writeback capabilities to record the user review actions. In the next several […]
Reviewing Clinical Data With Value Added And External Data
In my last post, I discussed performing a clinical data review in Oracle’s Data Management Workbench, which takes value added data into consideration. Today, we’ll take it a step further and add external data into the mix. This scenario extends the data available for review by including data from external partners who may be managing […]