Protocol
31-Aug-2023 STRATA Protocol_V7.0 Clean
2023.01.06 STRATA Protocol Synopsis V3.0
Superseded
06-Dec-2022_STRATA_Protocol_V6.0_Clean[1]
2022.12.05 STRATA Protocol_V5.0 Clean
2021.12.16 STRATA Protocol_V4.0
2021.10.25 STRATA Protocol_v3.0_Clean
2021.06.24 STRATA Protocol_v2.0
2020.12.11 STRATA Protocol_v1.0
2022.05.16 STRATA Protocol Synopsis V2.0
2020.12.16 STRATA Protocol Synopsis V1.0
Safety Templates
2020.12.17 STRATA Pregnancy Notification Form v1.0
2020.12.17 STRATA SAE Summary Log V1.0
- Refer to https://www.uhbristol.nhs.uk/research-innovation/for-researchers/templates-and-sops/templates-and-guidance/ for the most up to date templates for SAE report form & follow-up report form
No longer in use
2021.04.29 STRATA Non-Serious AE Log v1.0
Recruitment Material
2021.12.21 STRATA Clinician Referral Form v2.0
2022.02.08 STRATA Clinician Referral Patient Invitation Email V1.0
15-Nov-2022_STRATA_Recruitment_Poster_B_v1.0[1]
2021.01.28 STRATA Recruitment Poster v2.0
2021.01.28 STRATA Website support Safety Information v2.0
15-Nov-2022 STRATA Newsletter Text v1.0
STRATA Recruitment Poster v1.0 C 15-Nov-22
Superseded
2020.12.17 STRATA Clinician Referral Form v1.0
Patient Study Invitation Pack
2020.12.17 STRATA Easy Read Participant Information Leaflet v1.0
2020.12.17 STRATA GDPR Data Information Sheet v1.0
2021.06.24 STRATA Preliminary Screening EoI Paper V2.0
2021.06.24 STRATA Preliminary Screening EoI Online v3.0
15-Nov-2022_STRATA_Participant_Information_Leaflet_v3.0_clean[1]
2021.10.25 STRATA Patient Invitation Letter v3.0_Clean
2021.10.25 STRATA Patient Invitation Email V1.0
Superseded
2021.01.28 STRATA Participant Information Leaflet v2.0
2020.12.17 STRATA Preliminary Screening EoI Paper V1.0
2021.01.28 Preliminary Screening EoI Online v2.0
GP Safety Check
15-Nov-2022_STRATA_GP_Safety_Check_Cover_Letter_in_Email_v3.0_clean[1]
28-Nov-2022_STRATA_GP_Safety_Check_Form_v3.0_clean[1]
2020.12.17 STRATA GP Patient Safety Check Reminder v1.0
2020.12.17 STRATA GP Safety Check Initial Email v1.0
2022.02.28 STRATA Post EoI Letter for Interested Individuals V1.0
Superseded
2020.12.17 STRATA GP Safety Check Cover Letter v1.0
2021.12.16 STRATA GP Safety Check Cover Letter v2.0
2020.12.17 STRATA GP Safety Check Form v1.0
2021.12.16 STRATA GP Safety Check Form v2.0
Eligibility Outcome
2021.06.24 STRATA Eligibility Assessment [Not Eligible] Letter v2.0
2020.12.17 STRATA Eligibility Assessment Outcome [Eligible] Letter v1.0
2020.12.17 STRATA Eligibility Assessment Outcome [Holding] letter v1.0
Superseded
2020.12.17 STRATA Eligibility Assessment [Not Eligible] Letter v1.0
Baseline
2020.12.17 STRATA Baseline Questionnaire v1.0
2020.12.17 STRATA Carer Baseline Questionnaire Booklet v1.0
2020.12.17 STRATA Carer Consent Form v1.0
2020.12.17 STRATA Carer Invitation Letter v1.0
2020.12.17 STRATA Carer Participant Information Leaflet v1.0
2020.12.17 STRATA E-Consent Supplementary Information v1.0
2020.12.17 STRATA Participant Alert Card v1.0
2020.12.17 STRATA Participant Written Consent Form v1.0
2021.01.28 STRATA Medication Instruction Booklet v2.0
2021.01.28 STRATA Welcome Letter v2.0
2022.02.28 STRATA Participant Decline Letter V1.0
GP Correspondence
2021.10.25 STRATA GP Notification Letter v3.0
2021.10.25 STRATA GP Update of Involvement Notification Letter v2.0
15-Nov-2022_STRATA_GP_End_of_Trial_Notice_v3.0_clean[1]
2021.10.25 STRATA GP Medication Discontinuation or Withdrawal Letter v2.0
2022.02.28 STRATA GP Medication Discontinuation Email from study team v1.0
Superseded
2020.12.17 STRATA GP End of Trial Notice v1.0
2021.10.25 STRATA GP End of Trial Notice v2.0
2020.12.17 STRATA GP Medication Discontinuation or Withdrawal Letter v1.0
2020.12.17 STRATA GP Update of Involvement Notification Letter v1.0
2021.01.28 STRATA GP Notification Letter v2.0
Follow up
Correspondence
2020.12.17 STRATA 1-2 Week Medication Dose Confirmation Letter v1.0
2020.12.17 STRATA 4 Week Medication Dose Confirmation Letter V1.0
2020.12.17 STRATA 8 Week Medication Dose Confirmation Letter v1.0
2020.12.17 STRATA 12 Week Medication Dose Confirmation Letter v1.0
2020.12.17 STRATA 36 Week Medication Dose Confirmation Letter v1.0
2020.12.17 STRATA Carers Questionnaire Reminders v1.0
2020.12.17 STRATA End of Trial Notice v1.0
2020.12.17 STRATA Generic Change of Dose Letter v1.0
2020.12.17 STRATA Medication Discontinuation Notice v1.0
2020.12.17 STRATA Questionnaire Reminder v1.0
15-Nov-2022_STRATA_Thank_You_Letter_v2.0_clean[1]
2020.12.17 STRATA Withdrawal from Trial Notice v1.0
2020.12.17 STRATA Template Study Newsletter v1.0
Superseded
2020.12.17 STRATA Thank You Letter v1.0
Questionnaires
2020.12.17 STRATA 1-2 Weeks Questionnaire – Safety Check v1.0
2020.12.17 STRATA 4 Weeks Questionnaire – Safety Check v1.0
2020.12.17 STRATA 8 Weeks Questionnaire – Safety Check v1.0
2020.12.17 STRATA 12 Weeks Questionnaire – Safety Check v1.0
2020.12.17 STRATA 16 Weeks Questionnaire – Follow Up v1.0
15-Nov-2022_STRATA_24_Weeks_Questionnaire_-_Follow_up_v2.0_clean[1]
15-Nov-2022_STRATA_36_Weeks_Questionnaire_-_Safety_Check_v2.0_clean[1]
15-Nov-2022_STRATA_52_Weeks_Questionnaire_Follow_Up_v2.0_clean[1]
2020.12.17 STRATA Carers 16 Week Questionnaire V1.0
2020.12.17 STRATA Carers 52 Weeks Questionnaire V1.0
Superseded
2020.12.17 STRATA 24 Weeks Questionnaire – Follow up v1.0
2020.12.17 STRATA 36 Weeks Questionnaire – Safety Check v1.0
2020.12.17 STRATA 52 Weeks Questionnaire Follow Up v1.0
QRI & Qualitative
2021.02.02 STRATA QRI_STAFF info leaflet v3.0
2021.01.05 STRATA QRI_Consent Form_PATIENT RECORDINGS v1.0
2021.06.24 STRATA QRI_Consent Form_Patient Recordings-Verbal_ v2.0
2021.06.24 STRATA QRI_Consent Form_STAFF v2.0
QRI Consent Form for Staff – Online
Superseded
2021.01.28 STRATA QRI_STAFF info leaflet v2.0
2021.01.05 STRATA QRI_Consent Form_Patient Recordings-Verbal_ v1.0
2021.01.05 STRATA QRI_Consent Form_STAFF v1.0