Frequently Asked Questions
Here are some useful questions and answers we’ve collated along the way. We recommend checking here before contacting the ASCEND team, in case your query has already been answered.
Please check back as this section will be updated regularly.
Participant Expenses: Travel & Inconvenience
Are travel expenses are reimbursed?
Yes – Up to £100 per completed face-to-face visit (V1, V5, V6).
What proof is required for reimbursement?
Receipts or proof of cost must be submitted.
If screening and randomisation take place on separate days, how is reimbursement handled?
It is still considered one visit (V1) – only one £100 travel reimbursement is allowed.
Is there an inconvenience fee?
Yes, £100 inconvenience fee per completed face-to-face visit (V1, V5, V6).
Are expenses reimbursed if a visit is not completed (e.g., screen failures)?
Yes – but please bear in mind this may be reviewed if the number rises above levels seen at other sites.
Investigational Medicinal Product
Will we need to order more stock?
No. Double the amount of IMP/placebo needed to meet the recruitment target has been delivered to avoid any issues with supply
How are the IMP kits assigned to participants?
Each IMP kit is supplied with a kit/randomization number. Once the participant has been randomized, a blinded email will be sent to the study team (members designated to receive notification emails) and pharmacy team members, confirming the kit number to dispense.
Do I need a separate log on for the randomization system?
No – this is accessible via the study eCRF.
Do the site pharmacy teams require access to the eCRF/randomization system?
No – as they only receive notification emails. Email addresses will be uploaded into the randomization system.
Can our research nurses administer IMP?
Yes. Nurses are considered designees under the protocol.
Do nurses require direct doctor supervision to administer IMP?
No. Direct in-room supervision is not required. The investigator must provide supervisory support and be available if queries arise.
Does Pharmacy need to record when IMP is processed and temporarily removed from storage?
Yes. Please record the time taken out for processing and time returned to fridge (if applicable), to cover cancellations or delays.
How long can IMP be stored out of the fridge?
Up to 7 days cumulative at <30°C while in its carton.
What is the reportable temperature deviation range?
Outside 2–8°C. A temperature excursion reporting form must be completed.
How is IMP destruction documented?
Sites may use their own destruction log (template to be shared with Sponsor). Logs must be signed by delegated personnel. A Destruction Certificate is acceptable, but logs with signatures are also valid. Sponsor approval is required before destruction.
Can kit numbers be re-used/re-allocated?
No – once randomization has taken place, the kit number specified must be dispensed for the linked participant. In the event this kit is not used, it should be placed in quarantine with a notification sent to the Sponsor.
Screening and Randomisation
Can a patient be re-screened?
It is possible – please contact the ASCEND team with any specific scenarios
Can we use PIC sites to boost recruitment?
Yes! Please contact the ASCEND team ASAP with details as it takes time to set them up.
What are considered ‘safety’ bloods for eligibility review?
Liver function tests only, as per protocol v2.2 onwards.
Can visit 1 be split over two days?
Yes. From protocol v2.2 onwards, this can be done for any reason, as long as the visit is completed within seven days.
Is a gap between receiving flu/COVID vaccines and the study IMP recommended?
Yes – seven days if possible.
Remote Visits / Blood Sampling
Can visit 3 blood tests be taken remotely?
Yes they can – either at a local site or GP.
What if a GP is unable to carry out the blood testing required?
Please provide a phlebotomy form to participants and assist with arranging a phlebotomy appointment.
How will participants book a blood test within their visit window?
Participants will need to arrange phlebotomy appointments within the protocol defined window
Are pregnancy tests covered as standard of care?
No – the cost for this is included in the site funding provided
Are liver function tests considered standard of care?
No – they are trial-specific blood tests and the costs are included in the site funding provided
Laboratory Samples
Who will process blood samples?
All blood samples will be processed by the local hospital laboratory.
Do we need a lab manual for sample handling?
No. Local procedures should be followed – a lab manual will not be provided.
Do temperature excursion reports apply to blood samples?
No. Temperature excursion reporting refers only to IMP storage/handling.
Contraception
How long should contraception be used?
For the full 35-week study duration, until the last visit.
