SA05 – 20/12/2022 (Cat A)


Please ensure that your site has received local R&D approval to implement SA05 before downloading these documents or implementing this amendment.

As a Substantial amendment REC/MHRA/HRA approvals were required, and have been provided below.

Documents

EVIS Locked Tool 307862_Substantial Amendment 05_Download
EVIS-CTA-MhraProductsForm_ReadyForSubmission_20_12_22Download
EVIS-Clinical-Information-Sheet-INTERVENTION-v3.0-20.12.2022-1Download
EVIS-Clinical-Information-Sheet-USUAL-CARE-v3.0-20.12.2022-1Download
EVIS-PIS-ICF-Personal-Legal-Rep-England-Wales-NI-v2.0-16-Dec-22-Cle…-1Download
EVIS-PIS-ICF-Personal-Legal-Rep-England-Wales-NI-v2.0-16-Dec-22-TC….Download
EVIS-PIS-ICF-Prof-Legal-Rep-England-Wales-NI-v2.0-16-Dec-22-Clean-1Download
EVIS-PIS-ICF-Prof-Legal-Rep-England-Wales-NI-v2.0-16-Dec-22-TCDownload
EVIS-PIS-ICF-Prof-Legal-Rep-Scotland-v2.0-16-Dec-22-Clean-1Download
EVIS-PIS-ICF-Prof-Legal-Rep-Scotland-v2.0-16-Dec-22-TCDownload
EVIS-PIS-ICF-Recovered-Capacity-England-Wales-NI-v2.0-16-Dec-22-Clean…-1Download
EVIS-PIS-ICF-Recovered-Capacity-England-Wales-NI-v2.0-16-Dec-22-TCDownload
EVIS-PIS-ICF-Recovered-Capacity-Scotland-v2.0-16-Dec-22-Clean-1Download
EVIS-PIS-ICF-Recovered-Capacity-Scotland-v2.0-16-Dec-22-TCDownload
EVIS-PIS-ICF-Summary-v2.0-16-Dec-22-Clean-2Download
EVIS-PIS-ICF-Summary-v2.0-16-Dec-22-TCDownload
EVIS-PIS-ICF-v2.0-16-Dec-22-Clean-2Download
EVIS-PIS-ICF-v2.0-16-Dec-22-TCDownload
EVIS-PIS-ICF-Welfare-Attorney-Welfare-Guardian-Scotland-Clean-1Download
EVIS-PIS-ICF-Welfare-Attorney-Welfare-Guardian-Nearest-Relative-Scotlan…-1-1Download
EVIS-Protocol-V2.0-16-Dec-22-Final-Clean-1Download
EVIS-Protocol-V2.0-16-Dec-22-Final-TCDownload
EVIS-Summary-of-Protocol-Changes-V1.3-to-V2.0-16-Dec-22-1Download
EVIS-Protocol-V2.0-16-Dec-2022-Schedule-of-Assessments-1Download
EVIS-REC-Cover-Letter-SA05-21.12.2022Download
EVIS-MHRA-Cover-Letter-SA05-16.12.2022Download
IRASForm_20_12_22Download
22-SS-0009-AM07-IRAS-Project-ID-307862-Favourable-opinion-letterDownload
Notice-of-acceptance-of-AmendmentDownload