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 blog posts, we’ll explore a few of the basic design decisions and business rules that impact the implementation of Clinical Data Review. These includes:
- Determining type of review business rules
- Identifying new/Changed data
- Identify which data to review
- Design the User Interface
- Recording review actions
Today, we’ll discuss the first bullet point.
Determining Clinical Data Review Business Rules
Depending on the needs of the organization, one or more approaches may be taken for performing a review of your clinical data. This could include:
- Individual Review
In this approach, each individual may perform a review of their own. The review is complete as long as a single individual has performed the review. The same person reviews all data for a subject or study in order for the review to be complete, as appropriate.
- Group/Role-based Review (Any Reviewer)
Using this approach, anyone within the group (role) can perform the review of a specific record. As long as at least one person has reviewed the data, it can be deemed as reviewed. As long as all of the records for a subject or study have been reviewed by any members of the group, the review can be considered complete.
- Team-based Review (All Reviewers)
This is similar to the Group/Role-based Review (Any Reviewer), except that all members must review all of the data. For this case, it may be that different staff members are required to review the data for different reasons – Safety, Efficacy, etc. For the review to be complete, all members assigned to the Team must complete their reviews of the data. This could include additional business rules for the type/class of data to be reviewed by specific members/roles within the team.
Of course, there can be other variations of the above. The important consideration here is to identify the business needs of the review. When multiple reviewers are needed in different situations within the organization, care must be taken to establish an implementation approach to support them concurrently.
Whether it’s strategy, project management, or the implementation of technology, such as Oracle Data Management Workbench (DMW), my team can help improve your clinical data review process. Please send us an email to discuss your needs or fill out the “contact us” form in the footer of this page.