MoH: new requirements for clinical trials
On August 23, 2016 the Ministry of Healthcare of the Russian Federation approved Order No.200н ’On Approval of Rules for Good Clinical Practice’. The Order for first time covers requirements to electronic systems applied in clinical trials (Section III).
‘The new Order is a very important step for development of clinical research in Russia. Special software solutions are already widely used for a more accurate clinical data analysis and high-quality trial management, but only now do we have safety-based statutory standards as to what this software should be like. Most importantly, Data MATRIX products already meet these requirements, as compliance with these international standards was a design goal from day one,’ comments Data MATRIX CEO Ivan Dobromyslov.
Standard operating procedures (SOPs) are considered to be an important quality control instrument for clinical data management. Due to its commitment to SOPs, Data MATRIX now fully complies with the new requirements of the MoH, which is supported by all relevant documents. This allows to keep sponsors confident both in the company’s reliability and its compliance with new legislative requirements.
Today, the compliance with the new standards becomes more and more relevant in the light of recent pharmaceutical inspections initiated by the MoH and affecting even trial master files (also regulated by the Order). Data MATRIX applications have built-in change tracking and audit trail mechanisms. In addition, the company has its own established procedure for clinical data archiving, which provides for safe storage of all study documents in a separate archive with a restricted access.
Data validation is another important requirement which aims to avoid mistakes associated with working with data bases and apps. All Data MATRIX applications undergo verification and validation process to ensure the required quality is achieved.
Access control supports security of user accounts, confidentiality and integrity of all data. Data back-up policy provides for regular backups of data, operating systems and files, their storage and access control. The SOP for randomization, blinding and unblinding regulates access permissions to randomization lists and code breaking rules.
The new Order is another step towards the harmonization of requirements set forth by Russian and foreign regulatory authorities. It is expected that all this will have a positive impact on the level of confidence in clinical trials conducted in Russia and may potentially increase the number of international studies in the region.