Platform
Participants
Patients can be enrolled in the platform (i.e. co-enrolment of TRAITS platform participants) if they are already taking part in another study (either a non-CTIMP or CTIMP). Recruitment to the platform involves baseline data collection and research blood samples only. Therefore no formal written documentation is needed.
Trait Specific Protocol (TSP)
- Non-interventional studies
- Co-enrolment of TRAITS TSP participants to another non-interventional study (for example, sample only or questionnaire studies) is permitted and this does not require any formal written documentation.
- TRAITS participants can be co-enrolled in the following studies without the need for formal approval. Please note this list is not exhaustive. If you are unsure about co-enrolment please check with the trial team (TRAITS@ed.ac.uk)
- GenOMICC (GenOMICC)
- LiucuiD – Liquid biopsy In the Critically Unwell with acute Disease
- AFAR (Atrial Fibrillation After Resection (AFAR) – Health Research Authority (hra.nhs.uk))
- Synaptic – Study of Neurocognitive Associated Pathological and Transcriptomic Implications of Critical illness.
- Cardiac patients’ and their families’ perceptions of recovery after critical illness – a qualitative study at Edinburgh Napier University
- Interventional non-CTIMPs and CTIMPs
- Co-enrolment of TRAITS TSP participants to another interventional non-CTIMP (for example, diagnostic, device, or surgical interventions), or a CTIMP are permitted provided an assessment on the safety of the participants, interventions involved, participant burden and the potential impact on the study endpoints have been considered.
- The following interventional non-CTIMPs and CTIMPs have been assessed and co-enrolment agreements are in place:
- ABC Post ICU Trial (ABC Post ICU | The University of Edinburgh) (opens in new tab).
- MARCH (https://nictu.hscni.net/service/march-trial/) (opens in new tab)
- MOSAICC (https://www.icnarc.org/research-studies/mosaicc/) (opens in new tab)
- T4P (For sites | ICNARC) (opens in new tab)