Electronic records guidelines

Part 11 defines how electronic records must be managed. The retention requirements of such records are contained in the applicable predicate regulation. Table 22-1 refers to some of the sections in the predicate regulations or guidelines that specify record retention requirements. 

In Japan, the Ministry of Health, Labor, and Welfare published recently a guideline for the use of electronic records and signatures, whose main point is clearly in line with Part 11. 

TGL is an industry partner in a major research project, which provides one postdoctoral and two doctoral scholarships to further develop and optimize the production of electronic Therapeutic Guidelines, including the integration of Therapeutic Guidelines with prescribing, dispensing, and medical record management software. 

The investigator in the institution conducting the study should be aware of what happens to the medical records of study subjects who have participated in clinical trials. The medical authorities or the institution should have guidelines for the retention of records before they are changed into an electronic form by scanning, microfiched or destroyed. Usually when they are changed into another form, the medical records will be reviewed by administration staff and those items deemed not essential will be... 

New to the industry is the requirement that all electronically kept records be validated in accordance with the CFR (Title 21, Volume 1, part 11 revised April 1, 2003 requirement. This is particularly true of instances in which the systems are custom-designed and, furthermore, where computer-controlled automated processes are used. There remain many misconceptions about makes up computer validation. The CFR guideline as listed below should be well understood ... 

It is a group activity, optimally between five to ten people. At least two-thirds of the people invited to the brainstorming session should have ideally a variety of experience obtained in different fields. Preferably an experienced, neutral facilitator should run the session, whose job is to record the ideas on a flip chart, electronic white board or other appropriate technology and to stimulate and orchestrate the flow of ideas from the participants. For somebody inexperienced in facilitating a brainstorming session there are some guidelines to be followed. 

MHLW Guideline for the Use of Electromagnetic Records/ Electronic Signatures in Applications for Approval or Licensing of Drugs, etc. 

The Data Handling and Record Retention section of the protocol will address the requirement to maintain data (whether on a paper CRF or using an electronic data collection tool (DCT)) of each trial subject. It will address expectations of ownership of the completed CRF data, the investigator s responsibility to ensure accuracy and completeness of data recording. This section will also address the requirements for retention of records at the trial site in accordance with relevant guidelines and regulatory requirements. 

QOF was implemented in a context where guidelines and electronic medical records had increasingly been part of the landscape (Checkland 2004). Furthermore, in contrast to the surgeons we studied, GPs are generalists whose... 

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