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DASH-1 site
DASH trial
D
esmopressin for reversal of
A
ntiplatelet drugs in
S
troke due to
H
aemorrhage
Trial documents
Emergency contacts
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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
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to view superseded documents
Protocol v2.1 signature page.pdf
PROTOCOL DASH Final V2.1 - 05 May 2022.pdf
Amendments
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Statistical analysis plan
SAP dummy tables 1.0 26July2022.pdf
SAP version 1.0 26July2022.pdf
Information sheets
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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
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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
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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
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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
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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
See also:
list of recent changes
.
(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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