A Pilot Study into the Impact of Remote Monitoring on the Trial Site

Simple item page
dc.contributor.advisorStephen O. Mathew
dc.contributor.committeeMemberScott Maddux
dc.creatorPaulman, Brendan
dc.date.accessioned2019-08-22T21:43:50Z
dc.date.available2019-08-22T21:43:50Z
dc.date.issued2017-12-01
dc.date.submitted2018-05-22T12:18:08-07:00
dc.description.abstractRemote monitoring as the primary method of clinical trial oversight is increasingly common due to advancements in technology which allow SDV to be performed without site visits. However, remote monitoring often changes the workflow of the clinical trial site staff. This study aims to determine how remote monitoring affects the time allocation of site staff toward duties related to monitoring visits, and to identify which tasks are most affected when the sponsor uses a remote monitoring strategy. A survey was sent out to clinical research staff within BSWRI. Research staff tended to spend less time toward remote monitoring duties than on-site monitoring duties. Submitting source documents, regulatory, and AE documentation were identified as more time-consuming for remote monitoring, while preparing for visits and assisting the monitor while on-site were identified as more time-consuming for on-site monitoring. This study identified potential targets for improvements in the workflow of clinical trial sites.
dc.format.mimetypeapplication/pdf
dc.identifier.urihttps://hdl.handle.net/20.500.12503/29542
dc.language.isoen
dc.provenance.legacyDownloads7
dc.subjectMedical Sciences
dc.subjectMedicine and Health Sciences
dc.subjectMonitoring
dc.subjectremote monitoring
dc.subjectcentralized monitoring
dc.subjectSDV
dc.titleA Pilot Study into the Impact of Remote Monitoring on the Trial Site
dc.typeInternship Practicum Report
dc.type.materialtext
thesis.degree.departmentGraduate School of Biomedical Sciences
thesis.degree.disciplineClinical Research Management
thesis.degree.grantorUniversity of North Texas Health Science Center at Fort Worth
thesis.degree.nameMaster of Science

Files

Original bundle

Now showing 1 - 1 of 1
Thumbnail Image
Name:
2017_12_gsbs_Paulman_Brendan_practicum.pdf
Size:
2.14 MB
Format:
Adobe Portable Document Format
Download

Collections

School of Biomedical Sciences
Theses and Dissertations