IRT Training & Certification
Training is required for all individuals involved in conducting clinical trials, which includes the use of computerized systems such as IRT*. Regulatory guidelines indicate that “training should be documented, and the records retained and available for monitoring, auditing, and inspections.”
*EMA/INS/GCP/112288/2023. Good Clinical Practice Inspectors Working Group (GCP IWG)
IRT Training
IXRS University is Almac’s IXRS®3 training system that delivers user training via interactive online modules. The training curriculum is configured per study based on user role and included IXRS features.
Users will be required to complete training prior to the use of the IXRS for the study.
Each user is certified upon training completion and provided certificate via download. Study-level reports are available for sponsors to track training completion and as proof of compliance.
IXRS University – IRT Training and Certification
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IXRS University is seamlessly integrated into the system with Single Sign On, validated (21 CFR part 11 compliant), and available at study go-live.
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