Record Subject

It is important to have blinding of both the subject and the investigator wherever possible to avoid unconscious bias creeping in, either in terms of the way a subject reacts psychologically to a treatment or in relation to the way the investigator influences or records subject outcome. 

Reports may be considered to be reviews. For electronic documents that provide an interpretation of data drawn from electronic records that are already subject to control, there is no clear need to reimpose these controls until the document is used for some official purpose. In a case of submissions, once a submission has been assembled and approved ready for submission to a regulatory agency it would then become an electronic record subject to audit trails. 

Functionality that handles electronic records subject to specific regulatory requirements should be specifically identified in the URS. Individual records requiring ERES controls should be defined. The following aspects should be outlined for either the entire set of electronic records or a subset or for individual electronic records (a detailed discussion is provided in Chapter 15), as appropriate ... 

IPC-generated data and records subject to regulation by 21 CFR Part 11 are required to be retained for a defined retention period, typically for a number of years beyond the expiry date of the product. The retention period is to be determined by reference to predicate rules and a risk-based assessment of the value of the record over time. 

To bring objectivity to what can at times seem like a subject evaluation, testers can be provided with a review checklist based on the product s user interface requirements or a set of suitable heuristics such as Neilsen s [6]. The evaluator should also be diligent in recording subjective feedback and it can be useful at the end of the session to make a point of gauging general opinion and consensus. Some studies make use of video recording or input logging systems to detect subtle errors in interaction, hesitation and recovered errors. 

Whenever an employer is ceasing to do business and there is no successor employer to receive and maintain the records subject to this standard, the employer shall notify affected employees of their rights of access to records at least three (3) months prior to the cessation of the employers business. 

The problem of the difference between objective risk and subjective risk perception is avoided by the so-called psychometric models which aim to directly record subjective evaluations as a basis for decision-making processes. The expressed preference method [9-10], which uses opinion polls, did, however, show the change in the way the population evaluates technical developments. 

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