DISCLAIMER: The below documentation is intended for the use of NHS Hospital Sites in set up for the SWEET RCT only.

1. Submissions, Amendments & Approvals

Initial Submission:

IRAS Form- Submitted 30062023

23.SC.0254_300129_Letter_of_HRA_Approval_11.08.23

Application 23SC0254 IRAS Project ID 330129 Favourable Opinion

Non-Substantial Amendment 03:

10534 - NSA03 - Amendment Tool - 2023-11-30

IRAS 330129_ Amendment

IRAS 330129 - notification of amendment

Substantial Amendment 01:

Amendment Tool

Submission

REC: 05/06/24

HRA: 20/06/24

2. Contracts & Funding

Funder Export_330129_SoECAT_SWEET

mNCA_July_2022 SWEET (WP3 clean) October 2023

SWEET - OID - V1.0 2023-06-27

3. Protocol

SWEET_Protocol_v4.0_08Apr2024

4. Patient Facing Documents

SWEET_PatientInformationSheet_v4.0_03Apr2024

SWEET_InformedConsentForm_v4.0_03Apr2024

SWEET_GPLetter HTMe arm_v4.0_08Apr2024

SWEET_GPLetter Usual Care_v4.0_08Apr2024

SWEET_BaselineCoverLetter_v1.0_03Apr2024

SWEET_Invitation letter v1.0 23.05.2023

SWEET_Initial Appt Conf letter_v2.0_08Apr2024

HT&Me login card v1.0 28.06.2023

SWEET_FollowUpApptConletter_v2.0_08Apr2024

SWEET_HCPProcessEvaluation_PIS_1.0 15.06.2023 clean

SWEET_HCPProcessEvaluation_ICF_1.0 24.05.2023

SWEET_HCPProcessEvaluation_RemoteVerbalConsent_1.0 24.05.2023 clean

SWEET_HCPTopicGuide_1.0 26.06.2023

SWEET_ParticipantTopicGuides_1.0 26.06.2023

SWEET_Baseline Questionnaire Combined V2.0 24.11.2023 clean

SWEET_FollowUpQuestionnaire_v3.0_08Apr2024

5. Other

SWEET_DelegationLog_V1.0Date18.08.2023