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A consensus guideline iRECIST was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline.
The clinical trial software configuration is used in the GORD use case and consists of components needed for design, deployment, and collection of trial data, backed by provenance and secure authentication framework for researchers.
When a new participant enters the trial, it is necessary to ensure all the initial paperwork is complete (consent form, survey 1, swab A and recruiter survey), arrange for collection of trial data as soon as possible from the clinic to ensure there are no problems, and that swab A has arrived at the laboratory.
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The delivery of the trial within the practices, and the collection and management of trial data was the responsibility of Clare Jones.
Clinical trial conduct includes training the sites on how to administer the assessment instruments and monitoring sites for appropriateness of trial data collection.
The equal status of the two primary outcomes was agreed at a meeting of the Trial Steering Committee on the 21st January 2005, where the analysis plan was finalised prior to completion of trial data collection.
For instance, Goodman and colleagues explored solutions to integrate the EMR and EDC systems to enable accurate and efficient collection of cancer clinical trial data [ 9].
AZ was responsible for collection of data, trial monitoring and revision of the manuscript.
Data will be collected using Oracle Clinical Remote Data Capture RDCC), which is a new generation of application system that enables collection and cleanup of clinical trial data using the Internet.
FP contributed to the conception and design of the trial, data collection, statistical analysis, and writing of the manuscript.
M.K. is the Chief Investigator for the economic evaluation, S.N., S.H., M.B. (Beynon), M.C., L.R. contributed to the planning and administration of questionnaire trial data collection, S.H., M.C., M.B. (Beynon), L.R. and A.S. maintained and provided data on participants.
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