Audit Trail in Clinical Trials

 Introduction

An audit trail is documentation that allows reconstruction of the course of events. In the healthcare industry, an audit trail is an electronic record that tracks access to a patient’s medical information and update them. Audit trails exist in different forms and different fields to capture their unique areas of focus. The theme and purpose of the audit trail are to track a sequence of actions or events and actions in chronological order.

It is

•   Secure
•   Computer generated
•   Time stamped                          
•    Electronic record

It allows for the reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record

Contains metadata concerning the chronology of the record:

• Who
• What
• When
• Why

Need for an Audit trail

• Integral requirement of electronic record ensuring validity and integrity of the record.
• Link between electronic signature and record associated with it.
• Ensures lack of data integrity issues in the pharma industry.
• Add supportive evidence to a contract vendor audit.

What does Audit trail data signify?

• Identifies system security issues.
• Identifies errors in the sequencing of activities.
• Investigation of errors and unexpected events.
• Data integrity events.

Areas of risk to data integrity where Audit trail review is used:

• System Access
• Data changes
• Data collection
• Reporting
• Device concerns

At minimum it should consist of:

• User profile history
• Time and date of a document were set to final and viewable by all members of the study team
• Who participated in the processing of a document
• What steps a document went through before being set to final
• Number and type of issues associated with the document
• Documents that were deleted by whom and why.

It should be

• In a human-readable format as opposed to using the format and terms unique to that system.
• Should be accessible within the system by end users at any time
• Can be filtered and provide specific reports.

How often and by whom it needs to be reviewed

Reviewed with each record and before final approval of record by personnel responsible for Record Review.

Collecting Audit Trail Data

• The system should not delete or obscure previously recorded Audit Trail information.

o  The system should prevent user modifications to, or deletion of, the Audit Trail information

• System should record complete Audit Trail records.
• The system should store the user access history.

Preparing Audit Trail Data for Analysis:

• Consistent variable/data field naming across all Audit Trail records.
• Code list mapping.
• Consistent date and time stamp formats
• Consistent treatment of null versus empty string
• An internally generated key to facilitating the tracking of records that may require additional processing.
• Show the type of data change

Presenting Audit Trail Data:

• Audit trail should clearly show the before and after values for data changes.
• Reports should facilitate dynamic review and interaction with data through built-in filtering and sorting options and other functionalities.
• Data visualization should be used to translate high volumes of data into summary information that is more readily interpreted.
• Analytics including statistical methods can be used
• Reports should support the ability to export complete Audit Trails to widely used formats
• Data dictionaries can be used to interpret the data.

Key components:

• Process
• Roles
• Technology
• Standards                            
• Regulatory expectations  

Written By:

  Student Name: Iswarya Themadath

 ClinoSol Student ID:128/0722   

 Email Id: iswaryathemadath@gmail.com