Name: Implementing the ICF with a risk-based approach with the CRDe (en Inglés)
SKU: 59765131
Price: 185.18 PEN
Availability: InStock
Author: Frias, Aliuska ; Viada, Carmen ; Martinez, Liana
ISBN: 9786207429547

portada Implementing the ICF with a risk-based approach with the CRDe (en Inglés)

Implementing the ICF with a risk-based approach with the CRDe (en Inglés)

Formato

Libro Físico

Autor

Aliuska Frias

Carmen Viada

Liana Martinez

Editorial

Our Knowledge Publishing

Idioma

Inglés

N° páginas

Encuadernación

Tapa Blanda

Dimensiones

22.9x15.2x0.4 cm

Peso

0.11 kg.

ISBN13

9786207429547

Categorías

Tecnología: cuestiones generales

Implementing the ICF with a risk-based approach with the CRDe (en Inglés)

Aliuska Frias (Autor) · Carmen Viada (Autor) · Liana Martinez (Autor) · Our Knowledge Publishing · Tapa Blanda

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Reseña del libro "Implementing the ICF with a risk-based approach with the CRDe (en Inglés)"

Introduction: With the development of new technologies, the development of clinical trials (CTs) and electronic Data Collection Forms (DCRFs) has evolved. The traditional monitoring activity (MT) where 100% of the data was checked, has shifted to risk-based monitoring (RBM) and in particular, to comprehensive central monitoring (ICM). Aim: To implement ICM with the CRDe for a risk-based approach. Materials and Methods: Critical variables to be monitored in a clinical trial were selected. Key Risk Indicators (KRIs) were developed based on recommendations made by the regulatory agency. An MBR plan was developed. ICM was conducted at two points in time to measure the KRIs. Traditional monitoring was compared with comprehensive central monitoring for ICRs and to assess the transport, diet and accommodation costs generated by the monitoring activity. Results: 25 critical variables were chosen to be monitored in the selected clinical study, as recommended in the literature. With ICM, missing data were reduced by 83.03%, incorrect data by 97.36% and inconsistent data by 63.54%.