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dc.contributor.authorLe Gouill, S
dc.contributor.authorDreyling, M
dc.contributor.authorCaballero, MD
dc.contributor.authorAndre, M
dc.contributor.authorDoorduijn, J
dc.contributor.authorJurczak, W
dc.contributor.authorJerkeman, M
dc.contributor.authorGhia, P
dc.contributor.authorZinzani, P-L
dc.contributor.authorDa Silva, MG
dc.contributor.authorDimopoulos, M
dc.contributor.authorTrneny, M
dc.contributor.authorDelarue, R
dc.contributor.authorWalewski, J
dc.contributor.authorGisselbrecht, C
dc.contributor.authorLópez-Guillermo, A
dc.contributor.authorRule, Simon
dc.date.accessioned2022-03-18T14:42:08Z
dc.date.available2022-03-18T14:42:08Z
dc.date.issued2017-12
dc.identifier.issn2572-9241
dc.identifier.issn2572-9241
dc.identifier.otherARTN e4
dc.identifier.urihttp://hdl.handle.net/10026.1/18956
dc.description.abstract

Year after year, clinical research teams and investigating physicians are subjected to an exponential growth in administrative burden, paperwork, and regulation associated with clinical trials. The universal explanation for this ever-increasing workload is that it represents “good clinical practice” and is all about the safety of the patient and the integrity of the research. So whenever an investigator asks the question “Why should I fill out this document again?,” “Why should I write this sentence in the patient’s record again?,” “ Why should I sign all these electronic files?,” “Why should I write the date again,” the answer is immutably identical, it is GCP. This magic sentence stops all discussion because the risk for an investigator to be seen not to be respecting “good practices” could be a death sentence for his/her center and calls into questions his/her professional integrity and that of his (or her) collaborators. Once the words GCP have been pronounced, you have to resign yourself, obey and sign (or click, or write, or listen, or ask the patient to sign here and here, there and there, in two copies if not more).

dc.format.extente4-e4
dc.format.mediumElectronic-eCollection
dc.languageen
dc.language.isoen
dc.publisherLippincott, Williams & Wilkins
dc.titleIs Good Clinical Practice Becoming Poor Clinical Care?
dc.typejournal-article
dc.typeEditorial
plymouth.author-urlhttps://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000791289000004&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008
plymouth.issue1
plymouth.volume1
plymouth.publication-statusPublished
plymouth.journalHemaSphere
dc.identifier.doi10.1097/hs9.0000000000000004
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/Peninsula Medical School
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBR
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
dc.publisher.placeUnited States
dcterms.dateAccepted2017-10-20
dc.rights.embargodate2022-3-19
dc.identifier.eissn2572-9241
dc.rights.embargoperiodNot known
rioxxterms.versionofrecord10.1097/hs9.0000000000000004
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2017-12
rioxxterms.typeJournal Article/Review


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