Investigator Site File
DISCLAIMER: The below documentation is intended for the use of NHS Hospital Sites open to SWEET only.
Section 1: Reference Information
- Trial contacts and coordination team details: SWEET_Trial Reference & Contact Details_V2.0_17Apr2024
- Current ISF Version Control checklist: SWEET_VersionControlChecklist_v8.0_02Sep2025
Section 2: Protocol
- Current approved protocol: SWEET_Protocol_v5.0_28Jul2025
- Protocol deviation/non-compliance forms: CRF 10 - Protocol Deviation Form v1.0 10.10.2023
Section 3: Information for Participants
- Current approved patient information sheet: SWEET_PatientInformationSheet_v5.0_08Jul2025
- Current approved Data Handling Information sheet: SWEET_DataHandlingInformation_V1.0_28Jul25
- Current approved consent form: SWEET_InformedConsentForm_v6.0_26Jun2025
- GP letters: SWEET_GPLetter HTMe arm_v4.0_08Apr2024
- GP letters: SWEET_GPLetter Usual Care_v4.0_08Apr2024
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Any other written information given to patients: SWEET_PISCoverLetter_v1.0_08Jul2025
- Any other written information given to patients: SWEET_BaselineCoverLetter_v1.0_03Apr2024
- Any other written information given to patients: SWEET_Invitation letter v1.0 23.05.2023
- Any other written information given to patients: SWEET_Initial Appt Conf letter_v2.0_08Apr2024
- Any other written information given to patients: HT&Me login card v1.0 28.06.2023
- Any other written information given to patients: SWEET_FollowUpApptConletter_v2.0_08Apr2024
- Any other written information given to patients: SWEET_FollowUpCoverLetter_v2.0_28Jul2025
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Any other written information given to patients: SWEET_FollowUp_Postcard_v1.0_07May25
- ***NEW*** Any other written information given to patients: SWEET_EndOfStudyLetterInterventionArm_v1.0_18Nov25
- ***NEW*** Any other written information given to patients: SWEET_EndOfStudyLetterUsualCareArm_v1.0_18Nov25
Section 4: Main Ethics
- HRA/REC approval for protocol and supporting documentation: 23.SC.0254_300129_Letter_of_HRA_Approval_11.08.23
- HRA/REC approval for protocol and supporting documentation: Application 23SC0254 IRAS Project ID 330129 Favourable Opinion
- HRA/REC approval of amendments: Please see Amendments Page on the menu tab above.
Section 5: Individual Site Information and Approvals
- Site signature & Delegation Log: SWEET_DelegationLog_v2.0_21.08.2024
- SIV documents: SWEET_Site SIV & TrainingLog_2.0_27.06.2024
- Breast Cancer Now agreement (if applicable): BCN Homecare SLA_SWEET_Jan2025
Section 6: Manuals
- Current approved HT&Me How to guide: SWEET _HTMe - How to Guide V1.0 15.06.2023 CLEAN
- Current Approved Study Nurse Manual: SWEET:_HT&ME Study Nurse Manual V2.0 09.04.2024
Section 7: Monitoring
- Monitoring visit reports/letters/checklists: SWEET_Monitoring Visit Record Log_v1.0 12.10.2023
Section 8: General Site Information
- Study aids and promotional materials: SWEET_Participant Flow (SiteLed)_v1.0_12Apr2024
- Study aids and promotional materials: SWEET_Participant Flow (BCN)_v1.0_12Apr2024
- ***NEW*** Follow Up Guidance: SWEET_Follow Up Guidance_v1.0_10Nov25
Section 9: Data Collection
- Participant screening log: SWEET_ScreeningLog_v2.0_21May2024
- Participant enrolment (ID) log: SWEET Participant Enrolment Log v1.0 12.10.2023
- Sample Case Report Form & amendments: ***UPDATED***SWEET_CRF Booklet_BCN Led Model_v3.0_19Feb2026
- Sample Case Report Form & amendments: ***UPDATED***SWEET_CRF Booklet_Site Led Model_v3.0_19Feb2026
- Sample Case Report Form & amendments: SWEET Note to File_v1.0_27.06.2024
- Sample of Patient Questionnaire(s) & amendments: SWEET_Baseline Questionnaire Combined V2.0 24.11.2023 clean
- Sample of Patient Questionnaire(s) & amendments: SWEET_FollowUpQuestionnaire_v4.0_30Oct2024
- CDMS (Database) guidelines: SWEET_CDMS Guidelines_v1.0 05.02.2024
***SEE BOTTOM OF PAGE FOR INDIVIDUAL CRFS***
Section 10: Process Evaluation Documents
- Current approved HCP process evaluation information sheet(s):SWEET_HCPProcessEvaluation_PIS_v2.0_18Jun2025
- Current HCP process evaluation informed consent form(s): SWEET_HCPProcessEvaluation_ICF_v2.0 30Jan25
- Current HCP process evaluation informed consent form(s): SWEET_HCPProcessEvaluation_RemoteVerbalConsent_v2.0_17Mar25
- Process evaluation interview schedule and topic guide: SWEET_HCPTopicGuide_1.0 26.06.2023
- Process evaluation interview schedule and topic guide: SWEET_ParticipantTopicGuides_1.0 26.06.2023
Section 11: Trial Specific Working Instructions
- Copies of trial specific Working Instructions: SWEET_Hints&TipsForRecruitment_1.0 09.11.2023
Section 12: Tools and other miscellaneous documents
- Study Banner: SWEET_StudyBanner_v1.0_05Mar2024
- Study Poster: SWEET_StudyPoster_v1.0_05Mar2024
Link to Individual CRFs
| CRF Name | Link(s) |
| CRF 1- Registration CRF 2.0 30.01.2024 | CRF1 |
| CRF 2- Eligibility CRF 1.1 30.11.2023 | |
| CRF 3- Participant contact details 1.0 10.10.2023 | |
| CRF 4- Randomisation CRF 1.0 31.10.2023 | CRF4 |
| CRF 5- Baseline CRF 2.0 19.06.2024 | |
| CRF 6- Follow Up 1.0 24.11.2023 | CRF6 |
| CRF 7- Event form 1.0 10.10.2023 | CRF7 |
| CRF 8- Withdrawal form 1.0 10.10.2023 | CRF8 |
| CRF 9- Notification of Death Form 1.0 10.10.2023 | CRF9 |
| CRF 10- Protocol Deviation Form v1.0 10.10.2023 | CRF10 |
| SWEET Consultation Checklists 1 & 2 |