Trial documents

Approved protocol

• RECAST-3 Protocol Final V5.0 20240507 Clean signed.pdf

Expression of interest

Trial documents

• 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 7 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

• 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 3 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

• 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

• 995104 - Iss 01 - Product Training Guidance - AT4 Electronic Tourniquet - RECAST-3.pdf

Sponsor 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 4 days ago)
• MA-09-24 /   (updated 5 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

• 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 3 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