Acute Sub-Study

Acute sub-study site guidance

This guidance only applies to the recruitment of participants to the Acute sub-study.

Only a very small number of sites are recruiting to the Acute sub-study, so this page won’t apply to everyone.

Photograph of an adult holding a baby

The GenOMICC Acute sub-study follows the same process as recruiting to GenOMICC, with only two key differences:

  1. Acute participants must be recruited and sampled within 48 hours of admission to critical care

  2. Acute participants are required to give three samples, the usual DNA sample, then two others.

Eligible participants

All participants who are eligible for GenOMICC are also eligible for the Acute sub-study (if they can be recruited and sampled within 48 hours of admission to critical care).

Our entry criteria is online: Entry criteria

Acute study documents

We have a separate information sheet and consent forms to use when obtaining consent for the Acute sub-study.

The documents have a GenOMICC Acute logo at the top, so it’s easy to tell them apart from the usual GenOMICC set. We’ll localise the forms for you and send them on, if you have not already received them.

Sampling schedule

We need three samples from GenOMICC Acute participants, and although there is no sample processing at site, some samples do need some shaking and tilting. The details are noted below:

Table showing Acute sampling details

Specimen kits

We have separate GenOMICC Acute UN3373 specimen kits. You’ll be able to identify them easily as they have a large GenOMICC Acute sticker on the front.

The return postage label is attached to the box and is already paid - these kits can be posted as normal through any Royal Mail post box.

Acute sampling kit

Each kit will have 3 tubes inside, already pre-labelled with the participant ID stickers. There will be 2 spare ID stickers for the consent form/s. (Any unused stickers should be discarded).

All 3 samples are returned at the same time in the same internal plastic bag and postage-paid specimen kit.

We have a sample ‘draw’ order, and the ID labels are numbered 1 to 3. Please fill number 1 first and so on. In the unlikely event the full amount of blood is not available, please send what you can.

There are instructions inside each kit to remind you of the sample draw order and what needs to happen with each tube (see image).

Acute sampling kit

REDCap case report form

No additional information is required for GenOMICC Acute participants other than confirmation of the date and time of recruitment and the date and time of sampling.

The ‘Sampling details’ page of REDCap will hold the additional data fields for the entry of this information as shown below:

Acute sampling details data collection

Potential issues

Some possible issues:

• We have a sample draw order to make sure samples are received in a specific order of importance in the unlikely event not all of the samples can be obtained. If this happens, simply send what you can and let us know.

• Sadly, if the blood tubes are not shaken or tilted where required, this will affect the quality of the sample and the lab can usually tell. We’ll let you know if there are any issues with quality.

• If sampling happens after 48 hours of admission to critical care, then patients can only be recruited to GenOMICC as normal in this instance.

We also have a PDF download of the above guidance available to download.

We’re here to help, so please don’t hesitate to contact us with any questions.