Discussion of the main data management or database building issues that may be involved in the early stages of designing a new multicentre, clinical trial database using an EDC system. Presented by Lee Barker Monday, 18 th May 2015

2 Does the project have a finalised data set on which the EDC system can be built around? New innovative clinical trial projects may shift focus to other data entities and scale down or disband existing ones. Structural change to project data sets presents the issue of ‘missing’ data. Data already recorded at source, possibly on paper based form, can be directly entered into a modified EDC. Data not already captured will need to be sought after by approaching clinical nurse or patients.

33 What kind of EDC system will work best with clinical trial projects? Web based system will allow data entry across multiple platforms and locations. In-house solution. Off the shelf solution. Open Source ‘build your own’. Allows for an exact match in requirements, including changes to data structures. This incurs some time factors, e.g. software coding. Will often be based upon existing clinical trial projects and so would be suitable for projects sharing similar concepts. Projects can quickly build their own solutions. Such products have functionality for reporting, auditing, and methods of exporting data.

44 Data Quality The database should be ‘Normalised’ so that there is a data table serving each specific entity within the study, without unnecessary repetition, with the appropriate use of indexing. It should be fit for purpose to serve the context of the clinical trial study. There should be full documentation including data dictionaries to describe data structure including field descriptions and data types. Database catalogs can serve to provide a set of metadata.

55 Data Protection and Security Hold identifiable data separate from the main study data, i.e. a purpose database of name, gender, date of birth, date of death (if applicable), place of birth, and contact information. Such data will have a ‘key’ field which links records on the study database. The data should be easy to update to ensure all personal information is kept accurate. The EDC web and database system should be password protected and encrypted. Servers should be stored in secure locations with desktop access across the network conforming to the security procedures of the hosting institution.