Site Training Documents

Completing training – what site staff need to do

Some modules consist of a presentation only, whereas others may include additional documents. Please ensure you familiarise yourself with all documents associated with the relevant training module/s. You will see which training modules you are required to complete under the ‘Audience’ title for each module.

Training Log

To certify that you have completed the required training please complete the site training log. Training is self-directed and does not have to be completed all at once. When completing the form, please only select the training material that you have completed ON THE SAME DAY (complete a new form for training completed on other days). To complete the site training log click here.

 

Training Materials

Study Protocol

Audience

All staff involved with the study.

Download

In Study Specific Documents

 

Risk Protocol for Suicidal Thoughts and/or Ideation

Audience

All staff involved with the study.

Download

2022.04.01_RiskProtocol_SuicidalIdeation_V4.0

Superseded

2021.09.20_RiskProtocol_SuicidalIdeation_V3.0

2021.07.26_RiskProtocol_SuicidalIdeation_V2.0

2021.05.25_RiskProtocol_SuicidalIdeation_V1.0

 

Module 1: About STRATA

Audience

All staff involved with the study.

Download

2021.05.28 Site Training Module 1 About STRATA V1.0

 

Module 2: Patient Identification

Audience

All staff involved with identifying patients and the preliminary screening expression of interest stage.

Downloads

2022.05.20 Site Training Module 2 Patient Identification V3.0

2021.05.18_STRATA recruitment tips V1.0

Superseded

2021.05.28 Site Training Module 2 Patient Identification V1.0

2021.07.09 Site Training Module 2 Patient Identification V2.0

Additional Information

Please note staff recording discussions with potential participants for the QRI need to complete the QRI Staff Consent form here.

 

Module 3: Screening

Audience

All staff involved with patient (GP) safety checks at screening, and booking the baseline appointment.

Download

2021.05.28 Site Training Module 3 Screening V1.0

 

Module 4: Baseline Appointment Part 1

Audience

All staff conducting baseline study discussions, provisional eligibility checks, and informed consent.

Download

2021.06.14 Site Training Module 4 Baseline Part 1_V1.0

2021.11.02 Baseline appointment checklist V1.0

Additional Information

Please note staff recording discussions with potential participants for the QRI need to complete the QRI Staff Consent form here.

 

Module 5: Consent User Guide

Audience

All staff taking informed consent.

Downloads

2021.06.14 Site Training Module 5 Consent User Guide V1.0

2022.04.01_SiteTrainingConsent_CribSheet_V2.0

Video – Explaining the study and receiving informed consent:

Video – eConsent demonstration:

Superseded

2021.05.18_SiteTrainingConsent_CribSheet_V1.0

Additional Information

Please note staff recording discussions with potential participants for the QRI need to complete the QRI Staff Consent form here.

 

Module 6: Baseline Appointment Part 2

Audience

All staff confirming final eligibility, randomisation, and prescribing.

Download

2021.06.14 Site Training Module 6_Baseline Part 2_V1.0

 

Module 7: Follow Up: Safety Checks (1 to 2, 4, 8, 12, and 36 weeks)

Audience

All staff conducting safety checks, reviewing safety data, and prescribing.

Download

2021.06.25 Site Training Module 7 Safety Check Appointments_V1.0

2021.05.18_SiteTrainingSafetyCheckScripts_CribSheet_V1.0

2021.11.02 Safety check appointments checklist V1.0

Video – Example safety check appointment:

Module 8: Follow Up: Questionnaires (16, 24, and 52 weeks)

Audience

All staff involved in following up participant questionnaires at 16, 24, and 52 weeks.

Download

2021.10.28 Site Training Module 8 Follow Up Questionnaires_V1.0

 

Module 9: Pharmacovigilance (Safety Reporting)

Audience

All staff responsible for pharmacovigilance (recording/reporting of adverse events).

Download

2021.06.14 Module 9 Pharmacovigilance (Safety Reporting) V1.0

 

Module 10: Carer Study

Audience

All staff responsible for administrating the carer study.

Download

2021.10.07 Site Training Module 10 Carer Study Overview V1.0

 

Module 11: Change of Permissions / Withdrawal

Audience

All staff conducting baseline and follow-up.

Download

2022.05.20 Module 11 Change of Permissions Withdrawal V2.0

Superseded

2021.07.08 Module 11 Change of Permissions Withdrawal V1.0

 

Module 12: Introduction to the STRATA databases

Audience

All staff using the STRATA REDCap clinical and/or admin databases.

Download

2021.11.17 Module 12 Introduction to the STRATA databases V2.0

How to access University of Bristol Remote Desktop

 

Accessing STRATA Admin and Clinical Databases

Superseded

2021.07.30 Module 12 Introduction to the STRATA databases V1.0

 

Module 13: Study Medication Overview & Medication Status Calculator

Audience

All staff responsible for Baseline, Follow-up, and Safety Check appointments, and all staff involved in Prescribing.

Downloads

2021.10.07 Site Training Module 13 Study Medication Overview V1.0

2021.09.22 STRATA Medication Status Calculator MASTER V1.0