Remove tag terminology
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June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

Rethinking Clinical Trials

Terminology is important in research work, and we should strive to be as precise as possible with the terminology we use. Real-world data (RWD) is a term with specific regulatory implications referring to health care data routinely collected from a variety of sources. and the FDA Draft Guidance for RWD/RWE. pctGR, @Collaboratory1.

Big Data 130
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Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD)

Rethinking Clinical Trials

Identifying whether there are codes to represent the measures in standard terminologies. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD) appeared first on Rethinking Clinical Trials.

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Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Rethinking Clinical Trials

Learn more Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Discussion Themes – How have clinician views changed in terms of patient-reported symptoms verses clinician understanding of symptoms? You will want a dedicated tool for adverse events.

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Grand Rounds August 5, 2022: Economic Evaluation of Platform Trial Designs (Jay JH Park, PhD, MSc)

Rethinking Clinical Trials

Adaptive trial design is an overarching terminology for trials that use accumulating data in a formal way. Faculty of Health Sciences. McMaster University. Platform Trial, Study Design, Pragmatic Clinical Trials. Key Points. Calling them out is step one. Read the full study. pctGR, @Collaboratory1.

Trials 130
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Moving to component management & traceability: progress, barriers, and the way forward

pharmaphorum

It’s important to identify appropriate terminologies to support componentization. The process starts adding fields to regulatory submission templates that will incorporate re-used information, then building templates with standardized structures and including structured data tags and sources.