Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-
controlled prophylaxis study
Data Management Overview v2.0, 6th July 2020
2V2.0, 06 July 2020
Trial Data Overview
3V2.0, 06 July 2020
Site Staff Access to AxiomCOPCOV – Study Coordinator (Research Nurse) Training Workflow
1. Fusion Video Training
Trials Unit will provide Fusion Video Training Link to Site Personnel –
User will send their details of video completion to Axiom Customer Care at the end of the Video by completing Registration -
Registration:
Please click , enter your contact details, and click the Submit Details button.
2. Fusion User Registration
Once Step 1 is completed, our Customer Care Team will send an email with Fusion User Registration Details including the Study URL, as well as Training Certificate
3. Fusion User Activation
Axiom Customer Care to activate Users once Fusion Video Training has been completed, Fusion User Registration has been completed and Trials Unit has confirmed Site Assignment
4. Principal/Sub-Investigator Additional Video Upon first login Investigators will need to watch an additional ~10 minute video before they can enter data
4V2.0, 06 July 2020
• Expressions of Interest downloaded by the Trials Unit into an Excel spreadsheet
• Secure transfer to site via Trials Unit eRoom
• Access provided to site staff identified as responsible for downloading spreadsheet (minimum 2 per site for cross cover)
• Staff requiring access will be sent individual User Request Form for completion and return to Trials Unit (via a secure server)
• Login details will be sent to users via email
• Automatic email notification sent to users when file is uploaded by Trials Unit
• Login, download and save spreadsheet to Trust network
• Frequency of transfer will depend upon rate of completion
Site Staff Access to Recruitment Data
5V2.0, 06 July 2020
• Participant Card given upon enrolment
• Provides participant with:• Instructions on:
• Logging in to the Axiom Fusion website where they will enter Baseline/Visit 1 data etc.
• Downloading and logging in to the Axiom ePro Smartphone app where they will enter daily symptom check data
• Study team contact details
• Follow up visit dates
• COPCOV Study Subject eDiary User Guide
• Confirm WiFi available in clinic area for participant to download app
Participant Data Collection – Axiom ePRO
6V2.0, 06 July 2020
Participants will use this phone app to enter daily symptom check data
Participant Data Collection – Axiom ePRO (cont.)
7V2.0, 06 July 2020
• Participants will receive a notification on their phone each day as a reminder
• AND when a FU visit is due
Participant Data Collection – Axiom ePRO (cont.)
8V2.0, 06 July 2020
• Participants will use this website to enter baseline/visit 1, FU and some other data
• It works better on a PC, laptop or tablet/iPad
• Possible on a phone but awkward
Participant Data Collection – Axiom Fusion
9V2.0, 06 July 2020
Participant Data Collection – Axiom Fusion1. Select the form to complete from those available on the left e.g. baseline
2. The form will open for you to enter the data
10V2.0, 06 July 2020
Participant Data Collection – Axiom Fusion
Add other forms as required e.g. concomitant medication
11V2.0, 06 July 2020
Staff Data Collection – Axiom Fusion
Log in.
The Home screen will display
12V2.0, 06 July 2020
Staff Data Collection – Axiom Fusion
Select the “Manage Subjects” tab to see a list of the participants at your site.
Add a new participant by selecting “add subject” from the Page actions on the left.
13V2.0, 06 July 2020
Staff Data Collection – Axiom Fusion
• For site staff to complete a participant facing eCRF• Select the page action button
• This will unlock the page and allow entry of the visit details.
• If the post day 90 follow-up visit is not required, indicate as “Not
Applicable”
• Once data entry is complete on any form, mark the form as SDR to
enable review by monitors/data managers
• Select the page action button
14V2.0, 06 July 2020
Site Data Management
• Monitor participant status (well/unwell from dashboard)• Monitor daily ePRO data entry by participant• Ensure completeness of Axiom Fusion data if entered by participant • Reports available to assist with this process
• Subject e-diary data listing• Unwell subjects report
• Emergency paper CRFs are available if you cannot access Axiom
15V2.0, 06 July 2020
Select the “Subject eDiary” tab
View eDiary Overview Screen in Fusion
16V2.0, 06 July 2020
Click on column title to sort
View eDiary Overview Screen in Fusion
17V2.0, 06 July 2020
1. Access the available reports within Fusion by selecting the “ Reports” tab, and clicking on the title
2. Select the site from the Page actions then click on “submit”
3. The report is available from your “downloads” folder
eDiary Data Listing
18V2.0, 06 July 2020
1. Access the available reports within Fusion by selecting the “ Reports” tab, and clicking on the title
2. Select the site from the Page actions then click on “submit”
3. The report will display in your screen. If desired you can export as Excel or PDF.
Unwell Subjects Report
19V2.0, 06 July 2020
Central Data Management
• Data will be reviewed and queries raised within the Axiom Fusion system by the central Data Management team• Queries should be responded to within 5 working days• To correct entries within Axiom, amend the data• A prompt box will appear for you to record the reason for change
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Additional InformationReference Documents:• COPCOV UK CRF Completion Guidelines• COPCOV UK CRF Binder• User guides within Fusion
• e.g. Tips and Tools - ePRO Portal and Eligibility Review Tips and Tools
• COPCOV Study Subject eDiary User Guide
Always refer to https://www.copcov.org/sites.html for correct version of documents
If you have any further questions please contact [email protected]
V2.0, 06 July 2020