1. Do you need to change the way in which you identify potential participants? Has the clinical care pathway changed? | |
2. What are the infrastructure requirements for the proposed method of delivery (hardware, software, connectivity)? Are these supported by your organisation and available to potential participants? | |
3. Will Remote Trial Delivery introduce bias? If so, how can this be mitigated? | |
4. Are you able to provide participants with guidance and support in using the remote methods? | |
5. How will you ensure participants feel supported and have the opportunity to ask questions? | |
6. What training provision is there for your team and participants in any new methodologies? | |
7. Are the interventions, assessments and outcome measures validated for the planned use? | |
8. Will some aspects of trial delivery be more difficult (e.g. some safety assessments)? How will this be mitigated? | |
9. Are there any concerns regarding data security as a result of remote delivery? | |
10. Do you need to adapt your processes to ensure data integrity? | |
11. What additional processes for PI oversight do you need to develop? |