Reconciling Clinical and Safety Databases

¶ … Clinical and Safety Databases

Clinical databases and safety databases are some of the most common types of databases utilized by clinical and drugs safety organizations to comply with different data standards. These databases differ significantly in various ways including the fact that safety databases have much more strict requirements for quality and safety. While safety databases are derived from clinical databases, they vary in relation to the kinds of data included in them, their maintenance, and how and when they are used in data management. Despite their differences, an important aspect of clinical data management process is reconciling the two databases. Clinical Research Associates (CRAs) play an important role in reconciling clinical and safety databases. However, CRAs role in this process may be influenced by the nature of adverse events, progress of the clinical trial, and the use of coding dictionaries.

CRA Role in Reconciling these Databases

As previously indicated, Clinical Research Associates (CRAs) play an important role in reconciling adverse events between clinical and safety databases. Generally, CRAs provide statisticians with valuable feedback to help in identification, summary, and analysis of data with regards to safety and efficacy endpoints. The role CRA should play in reconciliation of adverse events between clinical and safety database is monitoring Case Report Forms (CRFs). This is an important role in ensuring adverse events between the databases are reconciled through providing vital feedback to Data Managers and Statisticians. Through monitoring, CRAs help Data Managers and Statisticians to reconcile the events through identifying, summarizing, and analyzing data, especially in relation to safety and efficacy.

Generally, Clinical Research Associates (CRAs) act as the major contact between the Data Managers/Drug Safety Officers and the investigator in the clinical trial (Ruiter, n.d.). In this case, the CRA monitors completed Case Report File (CRF) pages in the two databases. The Clinical Research Associate then provides feedback on safety and efficacy issues in the databases, particularly in relation to adverse events. CRAs send questions emerging from review or reconciliation by the Data Managers to the clinical trial investigator. Moreover, the Clinical Research Associate sends completed CRF pages to the Data Manager and Statisticians. Therefore, the role of CRAs in reconciling adverse events in these two databases is monitoring CRF pages after collecting them from the clinical trial investigator and providing important feedback regarding safety and efficacy. In some cases, the CRA retrieves and evaluates completed CRFs before handing them over to the Clinical Data Management (CDM) team in order to track missing pages or unwanted data (Krishnankutty, 2012, p.170).

Influences on that Role