PiPS Training Using the Randomisation Program Fiona Stacey PiPS Research Nurse Trial of probiotic to prevent necrotising entrocolitis and infection

You will need access to the internet! The randomisation program is located at: It can also be accessed via the PiPS website at: pips/ pips/ We can add a shortcut to this website in your favourites or on your desktop, please just ask. Site login details will be provided during site training visit and can be found on the underside lid label of the PiPS Documentation Box and on the inside cover label of the PiPS Site File. How to access the randomisation program

Select your hospital from the drop down box 2.Enter your username 3.Enter your password 4.Click login

Randomisation program homepage 1.Click for help 2.Status of packages at the site 3.Main menu 4.Emergency contact page (see Guidance Sheet 9) 5.Click here to return to this page at any time 5

Randomising a baby into the trial Before attempting randomisation please ensue that: The Consent Form is correctly completed - Ensure all fields are completed -Dates and study number -Names and signatures - If multiple birth, state birth order - Hospital name NOT number - Question boxes MUST be initialled! Part A of Form 1: Trial Entry is completed

Select the ‘Randomise baby’ link to go to the randomisation page

Randomisation page Using the information entered into Part A of the Trial Entry Form, complete the sections on this page and click on ‘Continue’

If all the information is correct, confirm by clicking ‘Complete’

1 2 Allocation of identifiers 1.The baby has been allocated an unique Study Number (this will not change throughout the study) 2.The baby’s allocated intervention package (this package must only be used for this baby) 3 Randomisation printout 3.Please print out the randomisation details for the baby’s medical notes

Randomisation details printout The randomisation details printout will list the following details: Where, when and who completed randomisation Baby identifiable information Allocated study number and package Intervention course start and finish dates Stool sample collection dates These details can be printed any time by selecting the ‘Print randomisation details’ link from the main menu.

Package identifier Baby identifiers Security tab (top) Security tab (bottom) Top of pack gives instructions and information about the intervention Identifiers are located on the side of the pack

Form 1: Trial Entry

Intervention Schedule Label

There are certain scenarios where allocation of an additional package may be required. At randomisation: -If you cannot find the allocated package in the NNU stock (please check with pharmacy first to see if it has been delivered) -If you find the allocated package but is already open Later during the treatment course: -If the baby’s package is lost -If there is not enough sachets left in the package (due to wastage) to complete the treatment course Before allocation of an additional package please check with the trial office. Allocation of an additional package

Select the ‘Allocate additional package’ link to go to the Re-allocation page

Select the baby’s Study number from the drop down box 2.Enter the Package ID Number of the last allocated package 3.Enter start date and click on continue

If all the information is correct, click on ‘Allocate’ to confirm

1 2 1.The baby’s unique Study Number 2.The next allocated package

Site Randomisation Information Using the randomisation program you can also access details of: Randomisation details of all the babies recruited at your hospital The status and location of each intervention package allocated at your hospital Number of days in and how many days are left in a treatment course for a baby randomised at your hospital How many packages have been allocated to a baby at your hospital

The summary bar has been updated and shows the number of packages now available on the NICU and in the Pharmacy

1 3 1.Total number of packs available at site 2.Total number of packs available in the pharmacy 3.Number of packages assigned to the NICU 4.Total number of packs available on the NICU 24

Click on the ‘Package list (detailed)’ link

Detailed list of all packages at site and their current status.

Click on log out, please do not leave the browser open once completed

If in office hours contact the PiPS Trial Office. If out of hours then refer to ‘Guidance Sheet 9: Procedures for emergency queries’. A link to the emergency contact details can be found on all pages of the randomisation program. If there is a problem with the randomisation program or website

Additional Questions & Contact Details