A technical approach to transfer Safety Events' Information from the Oracle Argus® to eAdjudication system for Clinical Endpoint Adjudication.
SAFETY MEDICAL RECORDS FOR ENDPOINT ADJUDICATION
The process of endpoints adjudication is a process implemented in Clinical Trials and Safety assessments to improve the quality of study results by reducing the bias of the Endpoints Assessments.
When a Safety Assessment relies on subjective analysis or involves investigators working in different countries there is the risk that the assessment made by different investigators could be not uniform or some way biased.
The sponsor or the Health authorities may then request a verification of the assessments, such as a disease diagnosis, its severity, the classification of adverse events, disease progression or regression, tumour size measurements, etc.
The sponsor can comply with the request involving an independent group of experts (the Adjudication Committee) that centrally repeat the assessment. Independent reviewers are blinded respect to each other assessment and usually to some data related to patients or sites involved in the trial.
IF SAFETY MEDICAL RECORDS ARE MANAGED WITH ORACLE ARGUS ®
Oracle Argus Safety ® is the industry’s leading drug safety system. It is an Oracle based data management system with a web-enabled user frontend. The main purpose of Argus is to collect and manage Adverse Events (AE) from all sources, e.g. clinical trials, spontaneous reporters, or literature. Events and medicinal products are coded and assessed using standard dictionaries and code-lists.
Pharmaceutical companies use Argus to fulfill their regulatory obligations towards health authorities in managing safety data from their medicinal products. This includes but is not limited to reporting of Individual Case Safety Reports (ICSR), periodic summary reporting, and signal detection.
In the post-marketing phase of a medicinal product life, Argus is a primary source of safety information. In the clinical phases, however, the clinical data management systems hold the majority of the information, Argus only deals with the Serious Adverse Events (SAE) occurring during the trials. There is a redundancy in the clinical data management system and Argus concerning these SAEs.
The eAdjudication software platform is designed to support Endpoint Adjudication Committee Members by providing them the dossiers about the events to be judged and by collecting these judgments in a quality and workflow controlled environment.
During the assessment, the eAdjudication system should retrieve the Medical Records and Safety Data about every adverse event so that it can assemble a complete package made of documents, data or images coming from the external systems used for the clinical data management.
Sometimes this information comes at least partially from an Electronic Safety Database system.
Argus can deliver significant information for the adjudication process in the following areas:
- assessment of individual cases;
- benchmarking trial cases against information from spontaneous or other sources;
- provide complementary information to the data coming from the clinical data management system.
ACCESSING ORACLE ARGUS ® SAFETY DATA
E2B R2 / E2B R3
Argus can generate single case data in XML format as specified in the ICH E2B guideline. Version 8 of Argus can deliver the E2B R3 format whereas earlier versions only support the E2B R2 format. The E2B file contains all relevant single case data. This information is suitable for detailed single case analysis of few cases.
E2B XML file can be sent to the eAdjudication system automatically as part of the reporting mechanism of Argus, provided the sender and recipient have an appropriate gateway, if not a manual transfer is possible. The automatic transfer mechanism requires the configuration of a reporting rule in Argus.
CSV FILE IMPORT
Argus has the functionality to create case listing reports. These reports list case information line by line.
Nearly all case information is eligible for inclusion in such a report. Once generated the report is available as PDF file for review and printing. The report can also be exported in several formats, CSV included.
The eAdjudication system can read and import the CSV file into the system. The information made available in this way is suitable for large amount of cases with selected/dedicated information, e.g. analysis of AE patterns, listing of AEs by organ class, listings of AEs by population parameters, or distribution of AEs by different parameter.
Access to Argus data using case line listings in CSV format requires an interaction with Argus, i.e. the report must be created and generated within Argus from an Argus user and the CSV file must be exported from Argus and imported and processed by the eAdjudication system.
DIRECT READ FROM ARGUS ORACLE DATABASE
The most efficient way to access Argus data is directly reading the data from the Argus Oracle database. Access to the transactional database is possible or, if Argus Mart is available, the mart tables can be read. Since Argus maintains a complete audit trail of any modification of the data, incremental access is also possible, i.e. only changed information will be transferred to the eAdjudication system.
Two scenarios are possible:
- re-load the entire case if the case data has been modified;
- only update changed case data in eAdjudication system.
Using incremental access can drastically increase the performance of the load process. Option 1 would be an easy but robust solution whereas option two would require more technical effort worthwhile in case of high volume or frequent case update.
The same results can be achieved with direct Argus data access as with using the CSV file import approach, e.g. analysis of large data volumes.
A tailored SQL query reads the data from the Oracle tables, and the results are directly uploaded into the eAdjudication system. The entire process can be automated and scheduled. No Argus user interaction is required. However, this approach requires an Oracle database connection and a read account to the Argus tables.
DISPLAYING ORACLE ARGUS SAFETY DATA
The Argus data in the eAdjudication system can be visualized like any other data used for the adjudication process. Possible visualizations are:
• Single case summary display of key medical information.
• Line listing of cases displaying individual key medical information of single cases in line-listing format, i.e. one line per case.
• Summary information presenting counts, percentages, etc. of key medical information grouped by selectable parameters, e.g. organ class, age, sex, seriousness, etc.
• Graphical charts displaying summary information, e.g. pie, histograms, curves, etc.
INTEGRATION WITH eADJUDICATION
The Argus data will be integrated with the eAdjudication system similar to the other information sources of the system with no functional difference to those.
The connector can create a new XML translated to the structure required by the eAdjudication web service API to import an event (for instance with EventID equals to the Argus case code if it is the source) and to define the value of a Key Variable (called AE.AGE) into the eAdjudication database.
To get this accomplished the connector can call a specific eAdjudication web service method:
https://mycompany.e-adjudication.net/eAdj_Import_Service.asmx?op=ImportData
After connecting, it sends the following XML to the importData API method:
<Events>
<Event>
<EventId>0002</EventId>
<FormId>1</FormId>
<KeyVariables>
<KeyVariable>
<Description>AE.AGE</Description>
<Value>33</Value>
</KeyVariable>
</KeyVariables>
</Event>
</Events>
The execution of this simplified connector program will at the end result in an updated event inside the eAdjudication platform ready to be reviewed by the Adjudication staff and, if complete, to be submitted to the Endpoint Committee members for Adjudication.
The connector can be scheduled to run during a specific timeframe (e.g. during the night), and it can also be designed to call other eAdjudication API methods.
E.g. to alert the Adjudication staff or to make other data transformation tasks.
*Oracle Argus Safety and any other registered trademark are the property of their respective owners.
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