Data managers for clinical trials should pay attention to recent changes made to the Good Clinical Data Management Practices (GCDMP) section on selection of systems for electronic data capture (EDC), according to information provided by OnlineCRF on the main points in the revisions regarding decisions to be made in this arena. The GCDMP standard, promoted by the Society for Clinical Data Management, is an important tool for data managers working for study sponsors, who ideally should be involved in cooperation with site staff in choosing the right EDC systems for the efficient conduct of studies.
Update 1: The basis for system selection is the sponsor’s business requirements
A statement of the project’s business requirements represents a key document for help in making EDC-related decisions. Here, the sponsor outlines all requirements for the electronic system, the conditions of user support, and the implementation of the software in the clinical project. The vendor and the sponsor together analyze the requirements to determine whether the product in question meets these criteria.
Here are the main points that should be included in the business requirements:
- general requirements of the vendor company and its product;
- requirements for the level of user support provided by the vendor;
- EDC system cost;
- functional requirements;
- technical requirements, including the system’s architecture and working environment; and
- confidentiality requirements and protection of clinical data in the system.
Update 2: Vendor evaluation is as important as the EDC system’s evaluation
GCDMP emphasizes the importance of carefully evaluating not only the electronic system, but also the vendor supplying it. Indeed, in the case of a clinical study, the interaction with the vendor does not end upon purchase of the system. After purchase, the sponsor can interact with the vendor for a long time; for this interaction to be as efficient and smooth as possible, sponsors need to take a responsible attitude toward the selection of the vendor.
OnlineCRF, based in Poland, distinguishes two main areas of vendor assessment. Each of these questions should be carefully considered and fulfilled in the business requirements:
- The vendor company must be reliable and have experience in the medical field of the study (cardiology, oncology, etc.). This will facilitate the trial and speed up many processes. The vendor also must understand the specifics of working on projects within a particular industry and all the regulations associated with it.
- The vendor’s work approach should coincide with the sponsor’s approach to business cooperation (i.e., in terms of communication, the interaction of team members, the timeline, and its performance). Each of these points should be clarified so that the vendor and the sponsor have the same vision for the project and all related activities and deadlines.
Update 3: The EDC system must be validated if it is configured according to a project
GCDMP pays special attention to the validation of electronic systems. It is during the validation that the EDC system is fully verified and its compliance with the objectives of a clinical study is confirmed.
When planning a project and choosing a vendor, be sure to specify:
- who has responsibility for the validation (i.e., the data management team of the vendor or the sponsor’s team of specialists);
- any relevant standard operating procedures (SOPs) for validating a system that is customized for a specific project—if validation is the responsibility of the vendor, SOPs should be formed by this team, but if the sponsor validates the EDC itself, it must also compile and agree on the appropriate procedures with the data management experts; and
- what validation documents should be prepared after validation to confirm the compliance of the system with the clinical research.
The most important considerations are that the sponsor clearly and correctly forms its requirements for the system, assesses the reliability and competence of the vendor company, and pays special attention to the issues and procedures for validating the system it is considering.
Author: Evheniia Smilianets, Head of Digital Communication, OnlineCRF LLC
