There are several types of electronic data capture (EDC) solutions that can be used to manage data in clinical trials. The selection of the data management tool will depend on the size of the study and the functionality needed.
It is very important that a detailed requirements analysis be done to determine these prior to making decisions on software. Possible constraints on choices will include cost and the possibility to customize the features, forms and fields of the EDC system.
Most large trials will require the use of software with powerful data handling features. Smaller studies could be managed using a smaller database system. It is important to carefully review the features and to select the product that will most closely meet the requirements of the project. Some features that may be important in selecting an EDC tool are:
- Data entry screens easy to navigate
- Support for direct data entry and data verification
- Ability to issue automatic and manual queries
- Built-in audit trail mechanism
- Data backup and recovery tools
- Solid security features
- Training and technical support by the supplier
When selecting an EDC solution, there may be no single data management system that meets all of the requirements. If this is the case, there may be a temptation to try to develop an in-house system and not use any commercially available package.
This may seem the best option to provide the required functionality but is probably not realistic in the majority of situations. The full development of a clinical data management application is a tremendously resource consuming work, and usually out of the scope of trial sponsors.