| Secure, private and effective eDiaries deserve the trust of regulators argue Valdo Arnera and Stephen A Raymond of PHT Corporation
When most of the regulations that pertain to handling records for clinical trials were written, diaries (like most records) were completed on paper. Except for a single mention that included ‘subjects’ diaries’ under the definition of source documents (1) provided by the International Conference on Harmonisation (ICH), they were not the focus of regulations.
Therapies were approved or rejected based on clinical records, and the direct input from subjects was generally secondary to the medical assessments of their physicians. Paper questionnaires were a trusted source, but in the 1990s many regulators and scientists were sceptical of patient diaries. As eDiaries have entered the mainstream, their regulatory status has become clearer (2), and the signs suggest that regulators are laying the foundation for increasing their reliance for claims and labelling on data supplied directly from subjects in clinical trials (2,3). BUILDING A CHAIN OF CONFIDENCE FOR ELECTRONIC RECORDS
The FDA sought to encourage “the widest possible use of electronic technology” in 1997 with Part 11 (4, Preamble). The objective was to describe what the FDA would need in order to trust electronic records as much as paper ones and avoid unduly burdensome controls. This ‘no worse than paper’ principle is embodied in the first sentence of the regulation (11.1(a)): “The regulations in this part set forth the criteria under which the agency considers electronic records ... to be trustworthy, reliable and generally equivalent to paper records...” (4).
From the design of the questionnaire or diary and its implementation on a valid device, to data transmission, storage, access, transfer and archiving, each step in the eDiary lifecycle is subject to regulations and guidelines that apply to both sponsors and sites. The eDiary providers must, therefore, prove to sponsors that their documented processes meet all the requirements for electronic records and that these standard operating procedures (SOPs) are consistently followed. In this way, the reviewers and regulators will have the information they need to establish a chain of confidence from development to final submission. By documenting compliance with the regulations, eDiary providers help study sponsors make the case that their data – and scientific conclusions – are trustworthy. |
