Impact of a targeted monitoring on data‐quality and data‐management workload of randomized controlled trials: A prospective comparative study

Author:

Fougerou‐Leurent Claire12ORCID,Laviolle Bruno123ORCID,Tual Christelle12,Visseiche Valérie4,Veislinger Aurélie12,Danjou Hélène12,Martin Amélie12,Turmel Valérie12,Renault Alain13,Bellissant Eric123

Affiliation:

1. CIC 1414 (Clinical Investigation Center)INSERM Rennes France

2. Clinical Pharmacology DepartmentCHU Rennes Rennes France

3. Experimental and Clinical Pharmacology LaboratoryUniv Rennes Rennes France

4. Clinical Research ManagementCHU Rennes Rennes France

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference38 articles.

1. International council for Harmonisation of Technical Requirements for Pharmaceuticals for human Use (ICH).Integrated Addendum to ICH E6 (R1): Guideline for Good clinical Practice E6(R2)[Internet]. [cited 2017 Oct 23]. Available from:http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf

2. Measuring data quality through a source data verification audit in a clinical research setting;Houston L;Stud Health Technol Inform,2015

3. Quality assurance within the scope of Good Clinical Practice (GCP)-what is the cost of GCP-related activities? A survey within the Swedish Association of the Pharmaceutical Industry (LIF)'s members

4. The Value of Source Data Verification in a Cancer Clinical Trial

5. Monitoring the quality of conduct of clinical trials: a survey of current practices

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