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PHOENIX trial documents

Initial Submission Documents:

HRA schedule – all activities

HRA schedule – no RT treatment

Statement of activities – all activities

Statement of activities – no RT treatment

Statement of Activities Summary Sheet

IRAS form

Protocol V1.0 (27/03/2017)

PIS AvB V2.0 (05/06/2017)

PIS AvBvC1vD1 HDR V2.0 (05/06/2017)

PIS AvBvC2vD2 HDR V2.0 (05/06/2017)

PIS AvBvC2vD2 IMRT V2.0 (05/06/2017)

Consent form V2.0 (05/06/2017)

GP letter V1.0 (28/03/2017)

Ethics favourable opinion

HRA approval

ARSAC PRA approval

Organisation Information Document (Non-Treating Sites)

Organisation Information Document (Treating Sites)

Substantial Amendment 1 Documents:

Cover letter

Summary of amendment

IRAS form

IRAS Amendment form

Amendment form IRAS highlight

ARSAC PRA amendment

Protocol V2.0 (17/10/2017) - clean

Protocol V2.0 (17/10/2017) – tracked changes

PIS AvB V3.0 (17/10/2017) - clean

PIS AvBvC1vD1 HDR V3.0 (17/10/2017) - clean

PIS AvBvC2vD2 HDR V3.0 (17/10/2017) - clean

PIS AvBvC2vD2 IMRT V3.0 (17/10/2017) - clean

PIS AvB V3.0 (17/10/2017) – tracked changes

PIS AvBvC1vD1 HDR V3.0 (17/10/2017) – tracked changes

PIS AvBvC2vD2 HDR V3.0 (17/10/2017) – tracked changes

PIS AvBvC2vD2 IMRT V3.0 (17/10/2017) – tracked changes

Consent form V3.0 (17/10/2017) – clean

Consent form V3.0 (17/10/2017) – tracked changes

REC Validation, categorisation and implementation information

Ethics favourable opinion

HRA Approval

Substantial Amendment 2 Documents:

Summary of amendment

IRAS Amendment form

Protocol V3.0 (14/06/2018) - clean

Protocol V3.0 (14/06/2018) – tracked changes

PIS AvB V4.0 (14/06/2017) - clean

PIS AvBvC1vD1 HDR V4.0 (14/06/2017) - clean

PIS AvBvC2vD2 HDR V4.0 (14/06/2017) - clean

PIS AvBvC2vD2 IMRT V4.0 (14/06/2017) - clean

PIS AvB V4.0 (14/06/2017) – tracked changes

PIS AvBvC1vD1 HDR V4.0 (14/06/2017) – tracked changes

PIS AvBvC2vD2 HDR V4.0 (14/06/2017) – tracked changes

PIVOTALboost PIS AvBvC2vD2 IMRT V4.0 (14/06/2017) – tracked changes

Consent form V4.0 (14/06/2017) – clean

Consent form V4.0 (14/06/2017) – tracked changes

REC Validation, categorisation and implementation information

Ethics favourable opinion

HRA approval

Substantial Amendment 3 Documents:

IRAS Amendment form

Protocol V4.0 (28/08/2018) – clean

Protocol V4.0 (28/08/2018) – tracked changes

REC Validation, categorisation and implementation information

Ethics favourable opinion

HRA approval

Substantial Amendment 4 Documents

IRAS Amendment form

Protocol V5.0 (24/05/2019) – clean

Protocol V5.0 (24/05/2019) – tracked changes

Summary of Amendment 4

REC Validation, categorisation and implementation information

Ethics favourable opinion letter

Ethics favourable opinion letter

HRA approval email

MACRO training videos

Module 1 - Logging In

Module 2 - Home Page and Tool Bar

Module 3 - Patient Navigation

Module 4 - Data Entry (Part 1)

Module 5 - Data Entry (Part 2)

Module 6 - Queries (DCRs)

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.