White Papers & Resources | Clinical Research Publications

A Case Study to Identify Required Schedule of Activity Characteristic Attributes

The HL7 Fast Healthcare Interoperability Resources (FHIR) interoperability standard is now implemented widely to share healthcare records.

Journal of the Society for Clinical Data Management (2024)

Andrew Richardson PDF | 3.07 MB

The role of FHIR Resources in ensuring Semantic Equivalence in EHR2EDC direct data capture

The HL7 Fast Healthcare Interoperability Resources (FHIR) interoperability standard is now implemented widely ...

PHUSE Conference, Paper RE08 (2023)

Patrick Genyn | Andrew Richardson PDF | 0.469 MB

Efficiency Ratios as a Method for Reviewing Statistical Computing Environment Key Performance Indicators

Efficiency ratios are used extensively to measure business and operational performance in many sectors,...

PhUSE Conference 2017, Paper PP05

Andrew Richardson PDF | 0.485 MB

Developing MDR Metadata Requirements for Operational Implementation

Metadata Repositories are increasingly being turned to as the solution to the management and operational ...

PhUSE Conference 2016, Paper PP06

Andrew Richardson PDF | 0.438 MB

An Algorithm for Prioritizing Time Constrained Clinical Trial Activities

An algorithm is described that can be used to automatically prioritize clinical trial or other operational tasks ...

PHUSE Conference, Poster PP25 (2019)

Andrew Richardson PDF | 0.499 MB

A Model for Reviewing the Operational Implementation of CDISC Standards

Whilst progress has been made in establishing clinical data standards, their operational implementation continues to challenge ...

PhUSE Conference 2015, Paper CD06

Andrew Richardson PDF | 0.989 MB

APESS: A Unified Methodology for the Development and Review of Quantitative Analysis SOPs

A simple but well aligned methodology for creating and reviewing standard operating procedures and the associated process documentation ...

PhUSE Conference 2018, Frankfurt, Paper SI14

Anthony Rossini | Anne Mounier | Andrew Richardson PDF | 0.273 MB

Generating Schedule of Activities as FHIR Resources

To utilise data originating in EHRs, methods are required to link subjects data to the study Schedule of Activities ...

PHUSE EU Connect 2022, Paper TH07

Andrew Richardson | Derek Hummerston PDF | 0.532 MB

Key Performance Characteristics of the Dev-QC-Prod Process

The characteristics of the Dev-QC-Prod process, described as a state system, are investigated to provide deeper operational insight ...

PHUSE Liverpool 2020, Poster PP12

Andrew Richardson | Derek Hummerston | Jonathon Ventham PDF | 0.538 MB

Integrating Real World Data: Some Practical Considerations

Practical considerations for integrating real world data, covering regulatory acceptance, data sources, integration strategy and data quality ...

PHUSE Single Day Event, Beerse, September 2019

Berber Snoeijer | Andrew Richardson PDF | 4.40 MB

Protocols on FHIR: Exchanging Study Designs with EHR Systems

How the HL7 FHIR standard can be used to exchange clinical study designs and the Schedule of Activities with EHR systems ...

PHUSE US Connect, Paper DS04

PHUSE Research on FHIR Group PDF | 2.27 MB

Playing with FHIR: How the FHIR Standard is supporting Clinical Research

An introduction to FHIR, the HL7 standard for health care data exchange, and the ways it is now supporting clinical research ...

PHUSE EMEA Autumn SDE, Utrecht, September 2022

Andrew Richardson PDF | 2.64 MB

Approaches to Schedule of Activities (SOA) Specification for Automated Implementation

The Schedule of Activities lies at the heart of each clinical study, yet always requires interpretation and manual intervention ...

PHUSE EU Connect 2020, Paper ML05

Andrew Richardson PDF | 4.08 MB

The role of FHIR Resources in testing and validating an EHR to Sponsor data pipeline

A method for testing and validating the data pipeline between site EHR systems and the trial sponsor using FHIR resources ...

fhir4pharma (2024), Paper RE01

Patrick Genyn | Andrew Richardson PDF | 2.28 MB

Study Designs using FHIR: Schedule of Activities Exchange using FHIR Resources

Work by the PHUSE Research on FHIR project team on exchanging the study Schedule of Activities using FHIR resources ...

PHUSE Research on FHIR Project, Paper RW05

Geoff Low | Mike Ward | Andrew Richardson PDF | 2.98 MB