eSource data

eSource data

In a clinical trial, source data that is captured initially into a permanent electronic record used for the construction and evaluation of a clinical study. Any changes made in a permanent record can be assessed via an audit trail.
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The company's eSource data has been accepted by both the Food and Drug Administration and the European Medicines Agency in successful regulatory submissions.
Accessed on-site or via the Instem Cloud, the Alphadas software solution suite is a proactive early phase CTMS, eSource data capture and reporting system.
These publications provide clarity around strategies and approaches which can be taken to ensure regulatory confidence in eSource data.
SGS began the process of implementing an eSource data capture system in its Antwerp, Belgium clinical pharmacology unit.
An early-phase eSource data capture, trial management and clinical site automation specialist, Logos leveraged Medidata's Web Services API to integrate data from its ALPHADAS([R]) Phase I solution with Medidata Rave([R]), an industry-leading system for capturing, managing and reporting clinical research data.
The combination of Cogstate's scientific and adult learning expertise with Clinical Ink's eSource data capture platform will deliver a single solution for sponsors looking to transcend traditional paper-and-pencil assessment scales in clinical trials.
Study Archive - PHT's Study Archive provides trial documentation in PDF format and eSource data in XML format, on media that is guaranteed by the manufacturer to be readable for 100 years.
This thought-provoking session will debate current esource data definitions and delve into scenarios that demonstrate the use of multiple electronic sources, along with regulatory hurdles.
Steve Wilson, FDA CDER Deputy Director of Biometrics, emphasized his perspective of "pro-science, pro-standards, pro-technology, and pro-critical path," and the need to ensure the collection of quality data, with the mention of several relevant initiatives, including the CDISC Operational Data Model (ODM), CDISC eSource Data Interchange document, CDISC/HL7 Protocol Representation Group, and standard data collection.
Kubick will participate in an eSource panel that focuses on industry issues and the development of recommendations relevant to the eSource Data Interchange (eSDI) for clinical trials, as detailed by the group's previously issued whitepaper.
The high quality of timestamped eSource data and the simple, intuitive user interface of the LogPad are especially important for respiratory trials where frequent assessments are critical to supporting efficacy.
eSource data, or data captured initially into a persistent electronic form, optimizes the clinical trial process by eliminating transcription errors and in the end, shortening the length of the trial.