The STRESS-L trial team will contact each site individually to provide the greenlight to locally restart recruitment.
Please do not restart screening or recruitment until you have received this greenlight.
The following items must be in place prior to your site recommencing recruitment which have been previously addressed in the restart questionnaire circulated previously to your site. If further clarification of these points is required the trial team will be in touch to confirm prior to issuing the greenlight.
- Confirmation research staff and PI are in place and have capacity to restart trial
- Confirmation from pharmacy that IMP stock is in place with no access issues
- Confirmation temperature monitoring including reporting of temperature deviations has continued for IMP stock during temporary halt to recruitment
- Confirmation lab supplies for blood samples are in place with no access issues to centrifuge and storage freezer facilities. (Please note: blood samples should not be taken for suspected or confirmed positive COVID-19 patients
- Confirmation access to database is in place (click here to test access with log in: https://ctu.warwick.ac.uk/StressL)
- Greenlight from sponsor to restart recruitment
Frequently Asked Questions
Q: Are COVID-19 patients eligible for STRESS-L?
A: Yes. COVID-19 patients are eligible for the trial but blood samples should not be taken for these patients to reduce risk of viral transmission.
Q: If there is a delay in receiving a test result to confirm the patient is COVID-19 positive, should the patient be randomised?
A: Yes. This patient should be randomised to the trial however; blood samples should not be taken as they have suspected COVID-19. We do not expect this to occur often, as by the time the patient is eligible for randomisation in to the STRESS-L the clinical status of the patient should be known. If the patient is not suspected or has received a negative test result for COVID-19, blood samples must be taken for these patients.
Q: Will evidence of a COVID-19 test be required for the trial?
A: Confirmation of a COVID-19 –ve (negative) test will be required when shipping blood samples from site to sponsor. A column has been added to the Blood Sample Transport Form that you must initial to confirm a –ve swab was received. Written evidence of the COVID-19 test result is not required. Please note: This is not required for any blood samples taken pre COVID.
Q: Can we co-enrol with other COVID-19 trials?
The STRESS-L trial team are currently reviewing the possibility of co-enrolment with other COVID-19 trials. Currently approval is in place for the RECOVERY-RS trial.
A full list of all co-enrolment trials can be found on the trial website, which is regularly updated: https://warwick.ac.uk/fac/sci/med/research/ctu/trials/stressl/health/coenrolment/
Q: To reduce risk of viral transmission due to COVID-19 we are using an app to upload a photo of the signed consent form that we print off and place a copy of in the Investigator Site File. Is this acceptable for STRESS-L?
A: Yes, as long as the NHS Trust are happy this information is secure in transmission and storage to the app, the trial team do not object to printed copies of the consent forms in site files.
Q: What is the definition of an impartial witness?
An impartial witness is a person, who is independent of the study and who cannot be unfairly influenced by people involved with the study. Therefore, they must not be listed on the trial delegation or investigator training log. Examples of an impartial witness include non-research bedside nurses and clinicians.
Q: If an impartial witness is not available when consent is required from a Personal Legal Representative, can consent be initially sought from a Professional Legal Representative?
If an impartial witness cannot be identified at the time of consent you can initially obtain consent using a Professional Legal Representative instead and ensure this is communicated to the relative. Thereafter, when an impartial witness is available, you should seek verbal consent from the Personal Legal Representative. This consent process and justification for this must be clearly documented in the patient’s medical records.
Q: Are electronic signatures acceptable on delegation logs?
Yes. Electronic signatures of site staff and the PI is acceptable as long as the PI sends email confirmation to confirm the site staff member added has been delegated the relevant responsibility codes alongside the date the site staff member joined the trial.
Q: Please can you clarify the 1 week rule in regards to temperature excursions up to 25°C?
Temperature excursions that do not exceed 25.4°C for a maximum duration of 1 week are NOT reportable to AOP. The 1 week clock starts when the temperature exceeds 8.4°C and stops when the temperature returns to 2-8.4°C. Therefore, if multiple temperature excursions occur within a 1 week period but individually each temperature excursion does not exceed 1 week these are NOT reportable to AOP and you can continue using the IMP stock.
Stability data has confirmed temperature excursions up to 25.4°C for less than 1 week do not pose any negative impact on the project quality or safety; therefore, the IMP can continue to be used.
PLEASE NOTE: Although Appendix 1 states up to 25°C, rounding rules apply; therefore, temperature excursions between 25.1 – 25.4 are rounded down to 25°C.