DATATRAK excels in Industry Standards compliance to help clinical studies become more efficient, safer, and easier to submit to regulatory agencies.
21 Part 11 Compliant
Title 21 CFR Part 11 constitutes the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures. Commonly referred to as Part 11, it outlines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. The guidelines stated in Title 21 CFR Part 11 apply to all FDA program areas. They are intended to permit the widest possible use of electronic technology and work harmoniously with the FDA’s responsibility to protect the public health.
DATATRAK is committed to driving industry standardization and has been registered as a CDISC consultant, system integrator and subject matter expert in the following CDISC standards, where we hold certification:
- CDASH – Clinical Data Acquisition Standards Harmonization
- Define-XML – Transmission of metadata
- LAB – Laboratory Data Model
- ODM – Operational Data Model
- SDTM – Study Data Tabulation Model
- SEND – Standard for the Exchange of Nonclinical Data
- Terminology – Controlled Terminology
DATATRAK is a Registered Solutions Provider supporting CDISC standards and providing a rich form library that includes CDISC standard domains, exports to SDTM and more.
HL7 – Health Level Seven International
HL7 is one of several ANSI-accredited Standards Developing Organizations (SDOs) operating in the healthcare arena. By using the HL7 messaging protocol as a standard, all systems following the HL7 specifications are able to communicate easily with one another, without the need for information conversion. DATATRAK supports HL7 standards including DATATRAK ECG Listener utility which allows customers to effortlessly load ECG files into the clinical database.
ICH – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
It is important to harmonize the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development. ICH guidelines and DATATRAK help sponsors improve the accuracy, speed and visibility of their SAE collection and reconciliation process.