Training

All training should be documented to evidence of completion.

1. Online

• The person who has undertaken the training must submit a FULL electronic training log entry to document they have received/undertaken the training (this includes an electronic signature).

• Electronic training log records are submitted by accessing an online tool available at the following link; https://bctu-redcap.bham.ac.uk/surveys/?s=9CXYNHDKCD.

• The tool can be revisited to submit further records of training BUT existing records will not be “edited” (removing the requirement for user logins), instead the new submission(s) will be taken as an update(s)/addition(s) to the existing record.

• After each submission, a PDF file is generated which is available to download at that point but will also be emailed to the address provided in the submission. The final page contains a summary of the submission along with the signature – this is to be printed AND filed with the paper log as it serves as an extension of the log. Copies can be obtained from the Trial Office.

2. Paper log (hard copy)

• The person who has undertaken the training must sign the log to document they have received/undertaken the training.

• The tool can be revisited to submit further records of training BUT existing records will not be “edited” (removing the requirement for user logins), instead the new submission(s) will be taken as an update(s)/addition(s) to the existing record.

• The log is filed in Section 3 of the Investigator Site File (ISF) - the local team is to be contacted to arrange completion of the log. 

This is provided by the SUNRRISE team during the Site Initiation Visit (SIV). It will be face-to-face whenever possible and ideally near the time of opening. Once open, further study-specific training (i.e. new staff) can be delivered via teleconference/video conference by SUNRRISE team, disseminated by the PI (or delegate) or undertaken online (see below).

This training must be completed by anyone undertaking trial-related activities.

There are are slides sets providing a brief introduction and also information on supplies that can be viewed, but these do not need to be documented as described above.

The overall slide set, combining all study-specific training is also available: SUNRRISE Study-Specific Training v1.0 (01-Oct-2020)

Staff should also:

• have access to and consult the guidance documents provided in the Investigator Site File (ISF), which include completion of CRFs (Section 12), completion of Signature Sheet and Delegation log (Section 4), and Adverse Event Reporting Guidelines (Section 13).     
• familiarise themselves with local arrangements and logistics though discussion with the local PI/research team.

This will be provided by Smith & Nephew representatives who will liaise directly with sites to arrange this. We will provide Smith & Nephew with the PIs contact details unless provided with alternate contact. Once open, dressing application training (i.e. new staff) is to be disseminated by the PI (or delegate).

This training must be completed by anyone who will be applying dressings to a of trial participant.

• General information on PICO 7 dressings, including videos on how they work and application demonstrations, can be found on the Smith & Nephew website and on the Smith & Nephew YouTube channel, including the following:

This is delivered online and can be accessed at the following link; https://bctu-redcap.bham.ac.uk/surveys/?s=DFPM7YMKRJ 

The training must be completed by anyone who will be reviewing the wound a of trial participant.