DASH trial – Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage

Trial documents

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Site start up presentation	Site_initiation_and_training_presentation_Protocol v2.0.pptx For the summary of product characteristics (SmPC) for desmopressin, please go to https://medicines.org.uk/emc/product/5447/smpc
Approved protocol	Please click here to view superseded documents Protocol v2.1 signature page.pdf PROTOCOL DASH Final V2.1 - 05 May 2022.pdf
Amendments	Please click here to view all amendments
Statistical analysis plan	SAP dummy tables 1.0 26July2022.pdf SAP version 1.0 26July2022.pdf
Information sheets	Please click here to view superseded documents INFO SHEET Final version v2.0 26 August 2019.doc Nominee PIS Final version v2.0 26 August 2019.doc Short pictiorial IS Final clean v2.0 11 Jan 2019 .docx
Consent forms	Please click here to view superseded documents Full Nominee Consent form Final version v2.0 26 August 2019.doc Full Participant Consent form PARTICIPANT CONSENT FORM Final version v2.0 26 August 2019.doc
GP letter	Please click here to view superseded documents GP letter v2.0 26 August 2019.doc
Sponsor's documents	2018-2019_Clinical_trials_insurance.pdf 2019-2020 Insurance Clinical Trials.pdf 2020-2021-Clinical_Trials_Evidence_of_Cover.pdf 2021-2022_Insurance_Clinical_Trials_TWIMC.pdf Use_of_your_personal_data_in_research.pdf RF1 TA008 Attendance Investigator Training.doc RF1 TA011 Participant screening and enrolment log v1.0.doc RF2 TA008 Delegation Log.doc
Sponsor Standard Operating Procedures (SOPs)	SOP TA008 Trial InitiationV3.5.pdf SOP TA009 CRF Design V1.0.pdf SOP TA010 TMF and TSF V2.0.pdf SOP TA011 ParticipantRecruitConsentV1.0.pdf SOP TA012 Trial MonitoringV1.0.pdf SOP TA013 Protocol Amendments V4.5.pdf SOP TA014 SAE Reporting V3.0.pdf SOP TA015 Trial closure V3.0.pdf SOP TA016 Serious GCP Breach Reporting V1.5.pdf
Working practice documents	Please click here to view superseded documents WPD 10 Closedown 20220331 v2.1.pdf WPD_002_Storage_guidelines_for_Desmopressin_v3_20200117.pdf WPD_003_Entry_of_missing_data_20181126_v1.0.pdf WPD_006_Emergency_Unblinding_procedure_20190110_v1.0.pdf WPD_007_Uploading_scans_20190918_v1.1.pdf
Co-ordinating centre	Day 90 Practice Manager Postal Letter.sa03 track changes.docx Site monitoring visit - ISF checklist v2.0_20210824.docx Site monitoring visit - patient file checklist_v2.0 20210824.docx WPD_001_Data_management_20181126_v1.0.pdf WPD_004_Database_testing_and_change_control_20181005_v1.0.pdf WPD_005_Manual_randomisation_20181127_v1.0.pdf WPD_008_Site_monitoring_visit_20210824_v2.0.pdf
Approval letters	233744 18-0184 Further Information Favourable Opinion 22.08.2018 (2).pdf 233744 Letter_of_HRA_Approval 04092018 copy.pdf CTA Acceptance of Amended Request.pdf
HRA documents	233744 DASH HRA schedule-events v2 18072018.xls 233744 HRA DASH statement-activities v2 18072018.docx Fw IRAS Project ID 233744 CI absence.pdf
Documents for pharmacy site file	Please note that the temperature log, which had been appendix 1, has since been removed and the remaining appendices were re-numbered. Please click here to view superseded documents Appendix 1 DASH Temperature Excursion Reporting Form v1.docx Appendix 2 DASH Receipt of supplies Form v3.doc Appendix 3 DASH Transfer Request Form v1.doc Appendix 4 DASH Pharmacy - Site IMP Inventory Log v1.docx Appendix 5 DASH Stroke Unit - IMP Accountability log v1.docx Appendix 6 DASH return of supplies from stroke unit v1.doc Appendix 7 DASH IMP Destruction Log v2.doc Appendix 8 DASH prescribing and administration guide v3.doc Appendix 9 - DASH Cumulative temperature Excursion Form v1.docx Lead Pharmacist Declaration v1.docx Pharmacy File Index (Generic) v1.doc Pharmacy Manual v4 - signed copy.pdf Prescribing and administration guide 12 Oct 2018 final 2.pdf Scanned DASH Pharmacy manual signature page.pdf
Trial documents	Contact sheet. v4.0 20220107.pdf Patient details v1.0 310119.docx File Note DASH.docx Recruitment Fax Cover Sheet DASH v1.0 310119.docx Screening log Fax Cover Sheet DASH v1.0 310119.docx
Post-publication documents	Infographic_FINAL_v1.0_20230621.pdf Trial_Lay_Summary_Final_v1.0_20230621.pdf
Printable CRFs	(updated 1,585 days ago) Randomisation v1.1 Day 1 follow-up v1.1 Day 2 follow-up v1.0 Discharge or death in hospital v1.1 Serious Adverse Event v1.1 (see also list of sub-categories) Protocol violation v1.1 Site-to-site transfer v1.0 Data correction request v1.0
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