form variable label coding 1 protocol anchor_centerprot Center ... - Plos

Variables212421332describe2PROTOCOL2specific2characteristics. # 1

form variable protocol anchor_centerprot

2

protocol center

3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

protocol protocol protocol protocol protocol protocol protocol protocol protocol protocol protocol protocol protocol protocol protocol protocol protocol

20

protocol piapplicant

21 22 23 24

protocol protocol protocol protocol

archive_id approval studyachronym studytitle contact_appl title_appl familyname_appl gvname_appl institut_appl street_appl postcode_appl town_appl country_appl tel_appl email_appl contact_pi contact_pipat

title_pi familyname_pi gvname_pi institut_pi

label Center.and.protocol.information Please.indicate.the.name.of.the.center.and.the.ethics. committee.providing.the.protocol Enter.local.archive.identification.number.of.the.protocol. Date.of.approval.by.ethics.committee Please.provide.the.study.acronym Please.provide.study.title.(quote!) Contact.data.of.the.local.applicant/local.PI/investigator Title.of.the.APPLICANT Family.name.of.APPLICANT Given.name.of.APPLICANT Name.of.the.department.of.the.APPLICANT Street.name.and.number.of.the.APPLICANT Postal.code.APPLICANT Town.of.the.APPLICANT Country.of.the.APPLICANT Telephon.number.APPLICANT Email.of.APPLICANT Contact.data.of.the.overall.principle.investigator Are.the.contact.data.of.the.overall.principle.investigator.given? Are.the.contact.data.of.the.local.principle.investigator.and.the. overall.principle.investigator.identical? Title.of.the.overall.Principle.Investigator Family.name.of.the.overall.Principle.Investigator Given.name.of.the.overall.Principle.Investigator Name.of.the.department.of.the.overall.Principle.Investigator

coding section.heading text text date text text section.heading Prof::Dr::Ms::Mr::unknown text text text text text text text text text section.heading yes::no yes::no Prof::Dr::Ms::Mr::unknown text text text

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form protocol protocol protocol protocol protocol protocol protocol protocol protocol

variable street_pi postcode_pi town_pi country_pi tel_pi email_pi language anchor_prop pilot

34

protocol completed

35

protocol completed_yes

label Street.name.and.number.of.the.overall.Principle.Investigator Postal.code.of.the.overall.Principle.Investigator Town.of.the.overall.Principle.Investigator Country.of.the.overall.Principle.Investigator Telephon.number.of.the.overall.Principle.Investigator Email.of.the.overall.Principle.Investigator Language.of.the.document Trial.Properties Is2the2trial2labeled2as2a2pilot2study? Is2the2trial2completed2according2to2correspondence2with2ethics2 committee? Yif.yes;.please.enter.the.exact.date.if.given:

coding

36

protocol completed_no

Y.if.no:.specify.reason.(choose.one)

37 38 39

protocol design protocol design_pararms protocol design_ratio

What2is2the2trial2design? Y.if.parallel.design:.indicate.number.of.study.arms Y.if.parallel.design:.indicate.the.ratio.of.randomization

40

protocol multicenter

Are.multiple.centers.included?

41 42 43

protocol multicenter_no protocol multicenter_type protocol randomization

Y.if.multi.center:.indicate.the.number.of.centers Y.if.multi.center:.indicate.type.of.multiYcenter What2is2the2unit2of2randomisation?

44

protocol target_pop

What2is2the2study2population2of2the2trial?

healthy2individuals::patients2suffering2 from2disease2or2at2risk2for2disease/event

45

protocol studypopulation

Please.specify.the.study.population.

text

text text text text text text English::German::French::other section.heading yes::no yes::no::unclear date stopped.for.benefit::stopped.for.harm::. stopped.for.futility::stopped.for.slow. recruitment::other parallel::cross4over::factorial::other number number single.center.trial::multi.center. trial::unclear number international::national.study::unclear individuals::clusters::body2parts

#

form

variable

46

protocol intervention

47

protocol intervention_desc

48

protocol control

49

protocol control_desc

50

protocol studylabel

51

protocol anchor_funding

52

protocol funding

53

protocol funding_industry

54

protocol funding_desc

55

protocol changes_prot

56 57

protocol changes_text protocol publ_status_anchor

label

coding medication::surgery2/2invasive2 What2is2the2type2of2experimental2intervention2(check2all2that2 procedure::rehabilitation::behavioral2 apply)? intervention::diagnostic2test::other Describe.experimental.intervention(s).in.detail. description no2active2treatment2/2standard2 What2is2the2type2of2control2intervention2(check2all2that2apply)? care::active2(drug2/2other2 treatment)::placebo2/2sham2procedure Describe.control.intervention(s).in.detail. description superiority2trial::non4inferiority2trial2/2 The2study2is2a: equivalence::unclear Study.Funding section.heading government2/2public::charity2/2private2 not2for2profit::industry2/2private2for2 What2is2the2funding2source2(check2all2that2apply)? profit::not2funded2/2only2in2house2 source::not2reported::reported,2but2 type2of2funding2unclear medication/device.only::more.than. Y.if.private.for.profit:.what.is.funded? medication/device::fully::unclear Describe.the.funding.source.of.the.study. funding.description trial2design2(e.g.2number2of2 arms)::experimental/control2 Does2the2correspondance/amendments2between2investigator2 intervention::sample2size/enrollment2 and2REB2mention2any2important2changes2with2respect2to2 issues::duration2of2follow2up::primary2 (check2all2that2apply): outcomes/analysis::subgroups::none::ot her Please.specify.any.changes.in.the.protocol: text Status.of.Publication section.heading

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63

64 65 66

67

form

variable

label coding Has.the.trial.of.this.protocol.been.published?.(will.be.evaluated. protocol publ_status yes::no::not.evaluated.yet::unclear by.the.team.in.Basel,.please.see.description.before.answering) publication.in.journal::only.abstract.for. protocol publ_status_type Yif.the.trial.was.published,.what.was.the.type.of.publication? conference::only.book::other Y.if.the.trial.was.published,.please.specify.the.first.author,.title,. protocol publ_status_typedescr text name.of.e.g..journal,.conference.or.book,.and.year. Y.if.the.trial.was.published,.what.is.the.source.of.this. protocol/correspondence.with. protocol publ_status_source information? REB::literature.search::author.survey Has.the.trial.been.stopped.early?.(MERGED.information,.please. protocol publ_stop yes::no::unclear::not.evaluated.yet see.description.before.answering) stopped.because.of.slow. Yif.trial.was.stopped.early,.what.was.the.reason.(check.all.that. recruitment::stopped.for. protocol publ_stop_dep apply)? benefit::stopped.for.harm::stopped.for. futility::other protocol/correspondence.with. protocol publ_stop_report Yif.trial.was.stopped.early,.what.is.the.source.of.this.information REB::publication::author.survey protocol anchor_clinicalarea Clinical.Area.and.Setting section.heading protocol clinicalarea Clinical2area2is... medical::surgical::paediatrics::other neurology::cardiovascular::respiratory::g astro/intestinal::nephrology::rheumatolo gy::infectious. protocol clinicalarea_med Y.if.medical.area,.choose.from.the.list: disease::oncology::intensive. care::hematology::endocrinology::derma tology::anaesthetics::psychiatry::other

#

form

variable

label

68

protocol clinicalarea_surg

Y.if.surgical.area,.choose.from.the.list:

69

protocol clinicalarea_ped

Y.if.paediatrics,.choose.from.the.list:

70

protocol setting_pts

Setting..and.patient.recruitment

71

protocol setting_spec

The2setting2for2the2majority2of2recruited2patients2is2(check2all2 that2apply):

72

protocol setting_age

The2age4group2of2patient2population2is2(check2all2that2apply):

73 74

protocol anchor_outcomes protocol primoutcome

75

protocol primoutcome_prim

76 77

protocol primoutcome_txt protocol comendpnt

Outcomes Is2any2outcome2specified2as2primary2outcome? Y.if.primary.outcome.is.specified,.only.one..or.multiple. outcomes? Y.if.primary.outcome.is.specified:.please.specify Y.if.primary.outcome.is.specified,.is.it.a.composite.endpoint?

coding general.surgery::obstetrics./. gynecology::neurosurgery::ophthalmolo gy::earYnoseYthroat. (ENT)::cardiothoracic::urology::orthopedi cs::plastic.surgery::other neurology::cardiovascular::respiratory::g astro/intestinal::nephrology::rheumatolo gy::infectious. disease::oncology::intensive. care::hematology::endocrinology::derma tology::anaesthetics::general. surgery::neurosurgery::ophthalmology::e arYnoseYthroat. (ENT)::cardiothoracic::urology::orthopedi cs::plastic.surgery::other section.heading community::outpatient2 clinic::emergency2department::in4 patients2hospital2care::intensive2care2 unit adults2(>=162yrs)::only2elderly2(>=602 yrs)::pediatric(