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Key resources

1. Links

• OpenClinica database: 
• Florence Healthcare eISF:
• 51³Ô¹ÏÍø OpenClinica training: /clinical-trials-unit/clinical-data-systems/cds-openclinica/training-openclinica-40/ (Code is CDSTraining_123)
• Florence training: 

2. Video tutorials

Randomisation on OpenClinica []. When viewing the video, for best resolution please ensure you have selected 1080 HD playback quality in Youtube’s settings.

3. Study Documents

•  (V3.0 09/01/2026)
•  (V2.1: 12/12/2025)
•  (V2.0 22/10/2025)
• Verbal Consent Statement (V2.1 12/12/2025)
• Cot Cards
• Paper note labels
• COLLABORATE Fliers

4. Study Manuals

• OpenClinica eCRF completion guidelines for consent and randomisation (V1.0 05/02/2026)
• Safety Reporting Manual (V1.0 09/02/2026)
• Vitamin and Mineral Supplementation Guidance (V1.2 21/01/2026)
• Discretionary Fortification Guidance (V1.2 21/01/2026)

5. Administrative documents

• Training summary
• User Activation Form
• File note template
• File note log
• Paper SAE form
• Protocol signature page
• Delegation log

6. Documents for consent and randomisation roles only

• SIV slides for consent and randomisation (v1.3 18/06/2026)
• OpenClinica eCRF completion guidelines for consent and randomisation (v1.0 19/06/2026)
• Please view randomisation video in the 'Video tutorials' section above
• Local study training attendance log (v1.0 04/06/2026) 

Training instructions for core study team

Ensure the following documents have been sent to collaborate@imperial.ac.uk , and you have received approval from the COLLABORATE team before you start undertaking any study duties:

1. Signed onto the study delegation log by PI
2. NIHR R3 GCP training certificate
3. Signed copy of CV
4. Completed training summary

If database access is required, additionally send:

1. Completed UAF form (study manager/monitor completes the final sign off)
2. Completed OpenClinica training certificate (study team to complete Data entry-study training, PI and sub-PI to complete Investigator training)

All resources can be accessed in the ‘Key Resources section’ above. Please note either wet ink signatures or digital signatures with the Adobe digital certificate are accepted by the sponsor.

Instructions for digitally signing on Adobe

Training for staff at recruiting locations, who are doing consent and randomisation duties only

A streamlined training process has been set up for staff working at participating COLLABORATE locations who are doing consent and randomisation duties only. This is to support rapid user activation to undertake these time-sensitive study duties.   

Documenting verbal consent and conducting randomisation requires individual access to the OpenClinica study database. Follow the below steps to confirm your study training, and have your OpenClinica account issued.

IMPORTANT please read:

Eligibility

• This process is only applicable for members of the clinical care/research team at participating locations who need to consent and randomise COLLABORATE participants, and will not be undertaking any other research duties.

Before you submit your request

• It is mandatory to be signed on by the PI (or authorised delegate) on the delegation log before completing the below form, and a copy must have been sent to collaborate@imperial.ac.uk . If you have not been signed on the delegation log/ this has not been received by the central team, your request will be rejected. Please refer to the delegation log for which duties can be delegated to users undertaking this training route.
• Ensure you have completed 1 of the 3 study training options:
  • Option 1: Self-directed training
    • Review the following documents available in the Key Resources section above: Study Protocol, PIS 1, PIS 2, Verbal consent statement, SIV slides (including GCP awareness slides)
  • Option 2: Attended a local training meeting
    • Local training to cover essential study documents and procedures, including: eligibility criteria, informed consent, randomisation, timeframes and principles of GCP
    • Attendance logs for local meetings need to be sent to collaborate@imperial.ac.uk , please check this has been sent or your form will be rejected. A template attendance log and slides are available in the Key Resources section.
  • Option 3: Attended a Live Site Initiation Visit (SIV) delivered by the Study manager/Monitor
    • Attendance logs for SIVs are held centrally and will be checked
• Ensure you have reviewed the OpenClinica training materials (Please review the OpenClinica eCRF completion guidelines for consent and randomisation, and randomisation video tutorial available in the Key Resources section above)

Submitting your user approval and OpenClinica access request

1. Check the above steps have been completed (you are signed onto the delegation log with a copy sent to the study inbox, you have completed one of the study training options, and reviewed the OpenClinica training materials).
2. Complete the  to confirm your study training and user account details

• Ensure you fully complete the form and enter your correct email address or your request will be unsuccessful.
• A copy of your responses will be sent to the email address provided

3. Wait for an email confirmation of approval from collaborate@imperial.ac.uk, who will also confirm your OpenClinica account has been requested

• • All submitted forms are reviewed and approved by the study manager/monitor. If for any reason your form has been rejected you will be notified and will be required to re-submit.

4. Forward the approval email to your lead research nurse for filing in the eISF

If you have any queries please contact collaborate@imperial.ac.uk