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Thursday, November 26, 2020
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Welcome to the PORTEC-4a trial website

CRF PORTEC-4a trial

 TitleModified DateSize 
Registration and Randomisation CRF 19/8/2020167.04 KBDownload
Pathology review and profile CRF 2A6/28/2019272.81 KBDownload
CRF PORTEC-4a (complete)4/16/2019371.65 KBDownload
eCRF Completion Guidelines6/3/201689.79 KBDownload
SAE form5/31/2016191.82 KBDownload

METC and site initiation documents PORTEC-4a trial

 TitleModified DateSize 
Ethics approval amendments PORTEC-4a protocol version 2.5.1, July 31 2020 EN8/3/2020151.60 KBDownload
Ethics approval amendments PORTEC-4a protocol version 2.5.1, June 26 20208/3/2020174.37 KBDownload
Listing of PORTEC-4a protocol amendments version 2.5.17/9/20207.76 MBDownload
Listing of PORTEC-4a protocol amendments version 2.57/9/2020648.93 KBDownload
ABR form PORTEC-4a protocol v 2.5.1 - 125062020 (latest version)7/7/20207.76 MBDownload
Verzekeringsbijlage PIF PORTEC-4a versie 2.4 (Dutch)8/23/2018157.30 KBDownload
ABR form PORTEC-4a protocol version 2.4 12 June 20188/17/20188.06 MBDownload
Listing of protocol amendments PORTEC-4a protocol version 2.48/17/2018199.91 KBDownload
Ethics approval amendments PORTEC-4a protocol version 2.4 12 June 20188/17/20181.24 MBDownload
Ethics approval amendments PORTEC-4a protocol version 2.310/18/20161.29 MBDownload
Listing of PORTEC-4a protocol amendments version 2.3 10/11/201671.36 KBDownload
ABR form PORTEC-4a protocol v2.3 - 11092016 (previous version)7/7/20208.04 MBDownload
PORTEC-4 zakkaartje (Dutch)8/26/201677.25 KBDownload
Ethics Committee addition participating site MCH 080720168/2/20161.11 MBDownload
Ethics Committee addition participating site MST 270620166/28/20161.17 MBDownload
Verklaring proefpersonenverzekering PORTEC-4a trial (Dutch insurance statement)6/28/2016717.81 KBDownload
WMO verklaring proefpersonenverzerkering (Dutch insurance certificate)6/28/2016109.27 KBDownload
Site signature and delegation log6/3/201658.74 KBDownload
Kick-off meeting presentation slides6/3/2016887.79 KBDownload
Insurance information Form (Dutch)6/25/201673.08 KBDownload
Ethics Committee Approval PORTEC-4a trial8/2/20162.36 MBDownload
Wetgeving, GCP en trialcoordinatie (v Leeuwen)7/29/2013438.34 KBDownload

Pathology

 TitleModified DateSize 
Pathology Standard Operating Procedure 5/31/2016137.78 KBDownload
Pitfalls in EC pathologie (Bosse)7/29/20134.84 MBDownload

Contacts

NameRoleEmail addressTelephone number
Ms Karen Verhoeven-AdemaCentral datamanager - Trial coordinatork.verhoeven@iknl.nl088 234 6125
Prof dr Carien L. CreutzbergPrincipal investigatorc.l.creutzberg@lumc.nl071 526 5120
Dr Remi A. NoutCo-Principal Investigatorr.nout@erasmusmc.nl+31 10 704 1366
Dr Tjalling BosseCoordinating Pathologistt.bosse@lumc.nl +31 71 526 6639
Drs Anne-Sophie van den HeerikJunior Investigatora.v.m.van_den_heerik@lumc.nl+31 71 526 5539