Version Control
STRATA-Local-Site-File-Version-Control-V3.0
General Correspondence
There are currently no documents in this section.
Screening and Recruitment Records
Screening and Recruitment Log
2021.12.01 STRATA [SITE] Individual Screening & Group Activity Log V2.0
Superseded
2021.06.28 STRATA Screening and Recording Log V1.0
Site Information and Research Personnel
Delegation Log
Template
2021.08.12 Site Delegation Log v3.0
Superseded
2021.08.03 Site Delegation Log v2.0
2021.02.12 Site Delegation Log v1.0
UoB Associate Status
Please contact central study team: strata-rct@bristol.ac.uk
Superseded
Associate-request-form
Site Set Up
Study Specific Documents
Health Research Authority and Local R&D
Initial Approval letter
270727 HRA and HCRW approval 02.02.2021
270727 initial assessment letter 13.01.2021
Organisation Information Document
Outline Organisation Information Document
2020.11.25 STRATA Organisation_Information_Document_Non-Commercial_V1.0
SoECAT
2020.10.15 STRATA SoECAT_NIHRHTA_ALL_Rai_FinalV1.0
Research Ethics Committee
Initial Application
2021.01.11 STRATA Initial REC HRA Application
V1.0 270727 conditions met 02.02.2021
270727 favourable opinion with conditions 01.02.2021
Amendments
Amendment 01
270727 2019-4556 SubAm1 080721
21FT0008AM01_Favourable_opinion_of_a_substantial_amendment
Amendment 02
Amendment 03
270727 2019-4556 SubAm3 031121
Favourable_opinion_of_a_substantial_amendment
Amendment 04
270727 NSA4 Amendment confirmation
Amendment 05
270727 2019-4556 SubAm5 221221 Amendment 05
Favourable_opinion_of_a_substantial_amendment (17)
Amendment 06
Amendment 07
270727 NSA7 Amendment confirmation
Amendment 08
IRAS_270727_Favourable_opinion_of_a_substantial_amendment
IRAS Project ID 270727. HRA and HCRW Approval for the Amendment
270727 2019-4556 SubAm8 040322
Amendment 09
RE STRATA Ethics amendment Id nr 1868471
Amendment 10
Amendment 11
2019 004312 66 270727 2019-4556 SubAm11 151222
IRAS Project ID 270727. HRA and HCRW Approval for the Amendment
Superseded
22SC0296AM11Favourable_opinion_of_a_substantial_amendment – 2022-12-28T094507.642
Amendment 12
270727 2019-4556 SubAm12 080223
22SC0296AM12Favourable_opinion_of_a_substantial_amendment7March2023
IRAS 270727 HRA Approval 22SC0296 SubAm12
Amendment 13
NSA13 270727 Amendment Confirmation
MHRA IMP Information
IMP Pharmacy Related Documents
IMP Label
2020.12.11 STRATA UK IMP Bottle Label 25mg Sertraline_Placebo V1.0
2020.12.11 STRATA UK IMP Bottle Label 50mg Sertraline_Placebo V1.0
IMPD
07-Oct-2022_STRATA_IMPD_V2.0_clean[1]
Attachment 1 – FDA – Aurobino Sertraline Monograph
Attachment 1 – SmPC – Crescent 50mg tablets
Attachment 2 – QG TSE-BSE 2019
Attachment 3 – Qualicaps Example – CoA
Attachment 4 – BSE TSE Vivapur
Superseded
MIA
Renaclinical GMP Certificate MIA (IMP) 49160
Renaclinical MIA(IMP) 49160 v7
Pharmacy Manual
10-Nov-2022_STRATA_Pharmacy_Manual_V3.0_clean[1]
Superseded
2021.05.26 STRATA Pharmacy Manual V2.0
Prescription Form
2021.03.31 STRATA Prescription Form – Starter Pack Week 0 V2.0
2021.03.31 STRATA Prescription Form – Unscheduled Appointment V2.0
2021.03.31 STRATA Prescription Form – Week 4 V2.0
2021.03.31 STRATA Prescription Form – Week 8 V2.0
2021.03.31 STRATA Prescription Form – Week 12 V2.0
2021.03.31 STRATA Prescription Form – Week 36 V2.0
SmPC
FDA – Aurubindo Sertraline Monograph
Initial Application
2020.12.11 STRATA CTA Form V1.0 Signed
2020.12.24 CTA Notice of Acceptance (MHRA Approval)
Amendment 03
Notice of acceptance of Amendment
Amendment 05
2019-4556 SubAm5 Notice of acceptance of Amendment (MHRA Approval)
Amendment 11
Notice of acceptance of Amendment
Funding and Sponsorship Arrangements
Sponsor Insurance Documentation
Uni of Bristol – CT VOI 2021-1
Superseded
CT2407 insureconfirm 2020-21
CTR Policy Schedule
Sponsorship Letter
STRATA full sponsor letter 110522 FINAL
Superseded
STRATA full sponsor letter 110122 FINAL
STRATA full sponsor letter 211221 FINAL
STRATA full sponsor letter 071221 FINAL
STRATA full sponsor letter 121121 FINAL
STRATA full sponsor letter 051021 FINAL
STRATA full sponsor letter 120821 FINAL
STRATA full sponsor letter 210721 FINAL with Annex3
Contracts
Templates
STRATA mNCA – updated 2021 (FINAL CLEAN)
Model_NC_PIC_Agreement_v1-0_June2019
Superseded
STRATA mNCA
CRF Data Collection Form
CRFs are completed on the study database. However, paper alternatives are available upon request.
Baseline
Revised Clinical Interview Schedule (CIS-R)
Not available on website. Please contact the STRATA Central Study Team.
Site Training Documents
Protocol Breaches & Violations
Template
CAPA form Sept23 FINAL to be used for all
Superseded
2021.03.31 STRATA Protocol Deviation Report Form v1.0