Choosing a Data Collection and Management System

Depending on the size of the CRO and the nature of the trial, the system may be acquired in one of the following ways: (1) developed in-house by the organization's staff with off-the-shelf commercial software, (2) outsourced to outside contractors, (3) with open source/free software (OSS/FS), and (4) purchased from e-clinical proprietary vendors.

The approach selected depends on various factors. The trial-related factors are usually derived from the trial's protocol. A summary of the trial's characteristic is identified and used to make a decision on the method to be used for data collection. These characteristics may include (1) kickoff date, (2) sample size, (3) length of subject intake, (4) length of follow-up, (5) trial duration, (6) number of participating sites, (7) number of data collection forms, (8) type of data collection, forms, (9) length of data collection forms, (10) complexity of data collection forms, and (11) type of collected data. Depending on these protocol characteristics, a decision can be made regarding the type of the data collection and management system. While paper-based systems are more suitable for small and short-term studies, electronic-based systems are more suitable for intricate trials that have complex rules and quick decision-making requirements. On the other hand, Internet-based systems are more suitable for studies that collect categorical data. In any case, several questions should be asked and answered before choosing a data collection and management system.

Other factors include available resources in terms of money and manpower to develop the system in-house, outsource, or purchase from e-clinical proprietary vendors, reliability, flexibility, and security. Some coordinating centers have chosen OSS/FS over proprietary vendors based on the criteria of cost, reliability, flexibility, and security [38]. The rationale is that although both have service comparability, proprietary software licensing costs, both for initial purchases and annual licensing, are significant.

The VA Cooperative Studies Program Persian Gulf trial was mandated by Congress and had to start right away. Therefore the pure paper-based data collection approach was chosen. The VA Cooperative Studies Program Parkinson's Trial started with pure paper-based data collection, and, as resources became available, data collection was migrated to DataLabs. The VA Cooperative Studies Program Diabetes Mellitus trial [39] was a very large trial. The limited manpower and financial recourses prohibited using an electronic-based system, so the pure paper-based system was used.

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