PiPS Pharmacy Training Randomisation Program and Intervention Stock Control

1. Trial of probiotic to prevent necrotisingentrocolitis and infection PiPS Pharmacy TrainingRandomisation Program and Intervention Stock Control Fiona Stacey PiPS Research Nurse

2. Top of pack gives instructions and information about the intervention Security tab (top) Identifiers are located on the side of the pack Package identifier Security tab (bottom) Expiry date

3. Inside are 91 sachets individually labelled Package identifier Expiry date

4. The supplier is Bilcare GCS • Delivery will be in set batches of 30 or 20 packages • Opposite is a sample of the batch delivery label • Deliveries will come with receipts detailing the consignment contents (sign-off receipts and store in the back of the PiPS Pharmacy File)

6. How to access the randomisation program • You will need access to the internet! • The randomisation program is located at: https://rct.npeu.ox.ac.uk/pips/login.php • We can add a shortcut to this website in your favourites or on your desktop, please just ask. • Pharmacy login details will be provided during site training visit and can be found on the inside cover of the Pharmacy File.

7. 1 2 4 3 Select your hospital from the drop down box Enter your username Enter your password Click login

8. 1 4 2 3 Randomisation program homepage Click for help Status of packages at the site Main menu Emergency contact page (see Guidance Sheet 9)

9. How to login an IMP shipment upon receipt • The PiPS Trial Office will initiate a shipment when the pharmacy stock level drops below 12 packs • The pharmacy will receive an email notifying them that a delivery has been dispatched • The first delivery to a site will contain 30 packages, thereafter restocking deliveries will only consist of 20 packages • Upon delivery check shipment for damage and inconsistencies (if you receive any damaged packages please retain for the PiPS Research Nurse) • Check-in the delivered packages using the Randomisation Program and update the Pharmacy Stock Balance Log • Sign-off the delivery receipt and store in the back of the pharmacy file

10. 1 2 Current status of packages at site and those due for delivery Click here to complete receipt of the shipment

11. The initial shipment IMP will contain 30 packages • Subsequent restocking deliveries will contain 20 packages • Check for any damage or inconsistencies by comparing the ‘package ID numbers’ on the packages with the delivery note and the randomisation program

12. 2 1 Select all packs Click on available for use

13. Confirm by clicking ‘Yes’

14. 1 2 3 4 Total number of packs available at site Total number of packs available in the pharmacy Number of packages assigned to the NICU Total number of packs available on the NICU

15. Stocking the NICU with assigned packages • The first stocking of the NICU will be with 12 packages, thereafter restocking of the NICU will be with 6 packages • The PiPS Trial Office will assign packages to the NICU for restocking when the NICU stock level drops below 6 packages • The pharmacy will receive an email notifying them to restock the NICU • The ID numbers of the assigned packages will be listed in the email and on the randomisation program • Only when the assigned packages have be stocked on the NICU should they be checked-in as available using the randomisation program • Update the Pharmacy Stock Balance Log

16. 1 2 Current status of packages at site and those assigned to the NICU Click here to see ID numbers of assigned packages

17. 1 2 Select the packages that were stocked on the NICU Click here to login packages

18. Select ‘Yes’ to confirm the packages have been delivered to the NICU • Doing so will allocate packages as available for randomisation

19. The package status summary is updated and shows the number of packages now available in the pharmacy and on the NICU

20. These links will only be available when a shipment is sent to the pharmacy or packages are assigned to the NICU

21. Add site name Complete these columns when the NICU is stocked Complete these columns for deliveries from the supplier Always complete these columns Add sheet number

22. Completing the Stock Balance Log • Each batch of packages sent from the supplier to the pharmacy will have package ID numbers in sequential order e.g. • Package ID numbers E1001 - E1011, E1013 - E1022...etc do not exist, hence you can record the delivery as E1000 - E1294. • When recording stocking of the NICU the assigned packages will not be in sequential order so you will have to write down each individual package ID number in the log. • If you make a mistake recording this information in the log, strike through once and sign and date the correction (do not use Tipp-ex!). E1000, E1012, E1023, E1038, E1041, E1059, E1064, E1076, E1085, E1097 E1106, E1118, E1124, E1130, E1145, E1153, E1161, E1177, E1189, E1192 E1205, E1213, E1222, E1239, E1246, E1258, E1267, E1271, E1280, E1294

23. Initial delivery of IMP Initial stocking of NICU Restocking delivery of IMP Restocking of NICU

24. Site Randomisation Information • How to access details of all the • packages at your site

29. If there is a problem with the randomisation program or website • 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 pager can be found on all pages of the randomisation program.

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

32. Trial of probiotic to prevent necrotisingentrocolitis and infection Professor Kate Costeloe PiPS Chief Investigator Tel: 020 8510 7225 Kate.Costeloe@homerton.nhs.uk Ms Fiona Stacey PiPS Research Nurse Tel: 020 8510 7168 Fiona.Stacey@homerton.nhs.uk Dr Paul Heal PiPS Trial Co-ordinator Tel: 01865 617924 paul.heal@npeu.ox.ac.uk