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ReCAST-3 site
ReCAST-3 trial
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Trial documents
Emergency numbers
For urgent medical enquiries (including unblinding), and for randomisation problems, you can contact the following emergency mobile numbers.
07810 540 604
07725 580 092
07798 670 726
Last updated: 23 September 2020
Approved protocol
» Please
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to view superseded documents
RECAST-3 Protocol Final V5.0 20240507 Clean signed.pdf
Expression of interest
» Please
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to view superseded documents
Trial documents
» Please
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to view superseded documents
(updated 11 days ago)
File Note RECAST-3 Site Delegation Log 20211007.pdf
RECAST-3 Co-enrolment Log for sites v2.0 20241018.pdf
RECAST-3 Contact sheet V1.5 20240212.pdf
RECAST-3 Eligibility Checklist V1.2 20241016.pdf
RECAST-3 England GP letter Final v2.0 20230905 Cln.doc
RECAST-3 Investigator Site File Index 20241211 V2.0.pdf
(updated 11 days ago)
RECAST-3 Medical Record Labels V1.0 20240216.docx
RECAST-3 Medical notes treatment delivery label template v1.0 20240409.docx
RECAST-3 Poster for staff only areas 20240524 v1.0.pdf
RECAST-3 Scotland GP letter Final Version V2.0 20230905 Cln.doc
RECAST-3 UKCRN Adoption Confirmation Email 20200325.pdf
File Note ISF - A.1 Trial Development Documentation 20221118.pdf
File Note TMF ISF - A.7 Database Build 20221118.pdf
File Note TMF ISF A.6 Randomisation and Blinding 20221118.pdf
File Note TMF ISF B.7 Biological Materials 20221118.pdf
File Note Template 20211027 V1.2.docx
Site Monitoring Visit Log 20211220 V1.0.docx
File note - sub-study not curently being delivered 20240321.pdf
Site training
» Please
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to view superseded documents
RECAST-3 AT4 Device training v1.0 20240617.pdf
RECAST-3 FAQs V4.0 20241017.pdf
RECAST-3 GCP for ward staff final version 1.2 20240416.mp4
RECAST-3 Investigator Training V3.1 20241107.pdf
RECAST-3 SAE electronic review process local PI Final v1.0 20241216.pdf
(updated 6 days ago)
RECAST-3 Ward Staff Training Log 20240419 V1.1.docx
RF1 TA008 Attendance Investigator Training RECAST-3 20231123 V1.0.doc
AT4 Device Interface controls V1.0 20240318.mp4
AT4 Device Participant set up and treatment delivery V1.0 20240318.mp4
AT4 Device Pre treatment checks V1.0 20240318.mp4
AT4 Device Troubleshooting V1.0 20240318.mp4
Data Corrections Guidance 20230307 V1.0.pdf
Information sheets and consent forms
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RECAST-3 England Consent form Final v3.0 20230905 Cln.docx
RECAST-3 England Consultee Declaration Form v3.0 20230905 Cln.docx
RECAST-3 England Consultee Information Sheet Final v3.1 20240507 Clean.docx
RECAST-3 England PIS Re-consent Final V3.1 20240507 Clean.docx
RECAST-3 England PIS V3.1 20240507 Clean.docx
RECAST-3 Scotland Consent Form Final Version V3.0 20231130 Cln.docx
RECAST-3 Scotland PIS Final Version V4.1 20240507 Clean.doc
RECAST-3 Scotland PIS Re-consent Final Version V4.1 20240507 Clean.doc
RECAST-3 Scotland Welfare Attorney Consent Form Final Version V3.0 20230905 Cln.docx
RECAST-3 Scotland Welfare Attorney Information Sheet Final Version V4.1 20240507 Clean.doc
RECAST-3 Telephone Consent Record V2.0 20230905 Cln.docx
Device documents
» Please
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to view superseded documents
995104 - Iss 01 - Product Training Guidance - AT4 Electronic Tourniquet - RECAST-3.pdf
Sponsor
documents
» Please
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to view superseded documents
Evidence of Cover Clinical Trials Insurance 01.08.2024 - 31.07.2025.pdf
RF1 TA011 Participant Screening and Enrolment Log.doc
RF2 TA008 Delegation Log and Codes (Ward Staff).doc
SOP TA008 Trial Initiation 20190128 V3.5.pdf
SOP TA010 TMF TSF 20180205 V2.0.pdf
SOP TA016 Serious GCP Breach Reporting 20180112 V1.5.pdf
Sponsorship Statement 20200310.pdf
REC documents
20-NW-0173 English REC Approval 20200527.pdf
20-SS-0047 Scottish REC Approval 20200611.pdf
277021 Letter of HRA Approval 20231204.pdf
MHRA documents
CI Professor Tim England CV Signed 20220608.pdf
CI Professor Tim England GCP 20220831.pdf
Substantial amendments
SA-07-24
/
SA-06-23
/
SA-05-23
/
Minor amendments
MA-10-24
/
(updated 8 days ago)
MA-09-24
/
(updated 8 days ago)
MA-08-24
/
MA-07-24
/
MA-06-24
/
MA-05-24
/
MA-04-24
/
MA-03-24
/
MA-02-24
/
MA-01-23
/
Trial working practice documents
» Please
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to view superseded documents
RECAST-3 WPD Log Updated 20240418.pdf
WPD 002 RECAST-3 Entry of Missing Data 20220923 V1.0.pdf
WPD 007 RECAST-3 Manual Randomisation 20220923 V1.0.pdf
WPD 010 RECAST-3 Site Closedown 20220923 V1.0.pdf
WPD 001 RECAST-3 Screening and Enrolment Log 20240410 V2.0.pdf
WPD 003 RECAST-3 Decontamination of RECAST-3 Equipment 20240410 V2.0.pdf
WPD 004 RECAST-3 Uploading Images to the RECAST-3 Database 20240410 V2.0.pdf
WPD 005 RECAST-3 Secure Vault Uploads - Site Process 20240410 V2.0.pdf
WPD 006 RECAST-3 Event Reporting 20240410 V2.0.pdf
WPD 008 RECAST-3 Protocol Deviations and Violations 20240410 V2.0.pdf
WPD 009 RECAST-3 Site Monitoring 20240918 V2.1 Clean.pdf
Newsletters
Newsletter Issue 1 June 2021.pdf
Investigator meetings
RECAST-3 Site Investigator Meeting final v1.0 20240912.pdf
RECAST-3 Site Investigator Meeting final v1.0 20241106.pdf
RECAST-3 Site Investigator Meeting v1.0 20240516.pdf
RECAST-3 Site Investigator Meeting v1.0 20240702 Final.pdf
RECAST-3 UKSF 2024 Investigator Meeting Slides Final V1.0 20241129.pdf
(updated 6 days ago)
Printable CRFs
See also:
list of recent changes
.
(updated 284 days ago)
Randomisation
v2.1
Day 1 follow-up
v2.0
Day 2 follow-up
v2.0
Treatment log
v1.0
End of treatment
v1.0
Discharge or death in hospital
v2.0
Serious Adverse Event
v2.0
(see also
list of sub-categories
)
Protocol violation
v2.0
Site-to-site transfer
v2.0
Data correction request
v2.0
Please log in to download a zip archive of printable CRFs.
Participant contact details should be submitted directly online.
A printable preview of the contact details form is available
here
.
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