GOOD CLINICAL PRACTICE AND CLINICAL DATA
Good Clinical Practice is a concept familiar to all those involved in conducting clinical trials in human subjects, but also should govern all interventions between health care professionals and their patients.
We all accept that the principle of respecting the rights of those we treat or study is of paramount importance and rightly emphasise the need for sound scientific justification in all we do. The need for ethical review, informed consent and full oversight of the conduct of the study or treatment effects is fully accepted in modern day clinical practice. All of these are pivotal to the production of sound and credible data. We produce these data by having a well-designed protocol which asks the right questions and lays down the way in which we will attempt to answer them. Data are verified against source documents to ensure accuracy and adverse events are faithfully recorded and evaluated to help to build up a body of data that will elucidate the benefit/risk profile of the investigational product or other intervention. All this is second nature in the modern clinical research environment. However, the generation of quality data depends on ensuring the safety of those data.
Data security is pivotal to the storage of your trial critical information and one way to provide reassurance that security is maintained is to ensure that those processes in place to store and analyse your data is to ensure that appropriate standards are applied and followed. Whilst many companies have their own internal procedures, additional reassurance can be provided by the adoption of external international standards which are independently audited and certified. The commonest of these are from the International Organization for Standardization, ISO. ISO standards are implemented by over a million organisations in over 170 countries.
The two standards which are directly applicable to electronic storage of data are ISO 9001 and ISO 27001. ISO 9001 sets out the criteria for a quality management system, a system that ensures the product meets both the needs of the customer and complies with any applicable regulations.
ISO 27001 provides the requirements for an Information Security Management System, which ensures that the company providing information technology and data management services has robust, managed and audited procedures in place to keep data secure.
TARA PV is marketed and supported by MedGenesis Limited, a part of the i-dash group and currently holds certification for both ISO 9001 and 27001. Data in the TARA PV system is held either in tier 4 data centres in the UK or, if clients prefer, in a secure Azure cloud. Tier 4 data centres are built to be fully fault tolerant and have hyper redundancy, with an expected uptime of over 99.99%.