PiPS Pharmacy TrainingRandomisation Program and Intervention

Stock Control

Fiona StaceyPiPS Research Nurse

Trial of probiotic to prevent necrotising entrocolitis and infection

Package identifier

Expiry date

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

Package identifier

Expiry date

Inside are 91 sachets individually labelled

• 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)

• 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.

How to access the randomisation program

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1. Select your hospital from the drop down box

2. Enter your username3. Enter your password4. Click login

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Randomisation program homepage1. Click for help2. Status of packages at the site3. Main menu4. Emergency contact page (see

Guidance Sheet 9)

• 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

How to login an IMP shipment upon receipt

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1. Current status of packages at site and those due for delivery

2. Click here to complete receipt of the shipment

• 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

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1. Select all packs2. Click on available for use

Confirm by clicking ‘Yes’

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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

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• 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

Stocking the NICU with assigned packages

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1. Current status of packages at site and those assigned to the NICU

2. Click here to see ID numbers of assigned packages

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1. Select the packages that were stocked on the NICU

2. Click here to login packages

• Select ‘Yes’ to confirm the packages have been delivered to the NICU

• Doing so will allocate packages as available for randomisation

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

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

Add site name

Add sheet number

Complete these columns for deliveries from the supplier Always complete these columns

Complete these columns when the NICU is stocked

• 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, E1097E1106, E1118, E1124, E1130, E1145, E1153, E1161, E1177, E1189, E1192E1205, E1213, E1222, E1239, E1246, E1258, E1267, E1271, E1280, E1294

Completing the Stock Balance Log

Initial delivery of IMP

Restocking delivery of IMP

Initial stocking of NICU

Restocking of NICU

How to access details of all thepackages at your site

Site Randomisation Information

• 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.

If there is a problem with the randomisation program or website

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

Professor Kate Costeloe

PiPS Chief Investigator

Tel: 020 8510 7225

Kate.Costeloe@homerton.nhs.uk

Trial of probiotic to prevent necrotising entrocolitis and infection

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