Maintaining electronic regulatory binder at clinical trials site improves efficiency

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dc.contributor.authorHemlata, Sukhijaen_US
dc.contributor.authorKhanna, Deepikaen_US
dc.date.accessioned2020-05-06T08:33:34Z
dc.date.available2020-05-06T08:33:34Z
dc.date.issued2019-07
dc.description.abstractRegulatory binder is one of the essential documents that isrequired to be maintained by all clinical sites throughout the conduct of clinical trials and post completion of clinical trials. Managing regulatory binders for multiple studies has been challenging due to large volume of documents that needs to be maintained in a paper form especially when the site has 150-200 open studies. To utilize electronic regulatory binders to replace paper based regulatory binders for improve efficiency while maintaining regulatory compliance. Use of document management system effectively allows sites to store regulatory binders electronically.Electronic regulatory binders provide a new way of managing tons of documents in a simplified fashion that helps in redefining the process, tracking documents, reducing physical storage requirements, retention, preparation for monitoring visits, and in prompt audits.en_US
dc.identifier.affiliationsDepartment of Surgery, Center of Expertise Healthy Ageing, Hanze University of Applied Sciences, Groningen, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Radiology, Center of Expertise Healthy Ageing, Hanze University of Applied Sciences, Groningen, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Epidemiology, Center of Expertise Healthy Ageing, Hanze University of Applied Sciences, Groningen, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Rehabilitation and Health Psychology, Center of Expertise Healthy Ageing, Hanze University of Applied Sciences, Groningen, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Nuclear Medicine and Molecular Imaging and Intensive Care, University of Groningen, University Medical Center Groningen, Groningen, The Netherlandsen_US
dc.identifier.affiliationsResearch Group Healthy Ageing, Allied Health Care and Nursing, Center of Expertise Healthy Ageing, Hanze University of Applied Sciences, Groningen, The Netherlandsen_US
dc.identifier.citationHemlata Sukhija, Khanna Deepika. Maintaining electronic regulatory binder at clinical trials site improves efficiency. International Journal of Clinical Trials. 2019 Jul; 6(3): 147-150en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/200929
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber3en_US
dc.relation.volume6en_US
dc.source.urihttps://dx.doi.org/10.18203/2349-3259.ijct20193218en_US
dc.subjectElectronic regulatory binderen_US
dc.subjectClinical trialsen_US
dc.subjectStudy binderen_US
dc.subjectInvestigator's study filesen_US
dc.titleMaintaining electronic regulatory binder at clinical trials site improves efficiencyen_US
dc.typeJournal Articleen_US
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