EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 1_Version 2.0 dated 29/07/15 Page 1 of 3 EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 2_Version 4.0 dated 23/08/18 Page 1 of 3

Guidance Sheet 2: Randomisation

Complete Section A of Form 1: Trial Entry and check that the baby is eligible.

o The randomisation program will not accept a baby who does not meet the eligibility criteria.

Log in to the randomisation program at https://rct.npeu.ox.ac.uk/babyoscar/login.php. o Your login details can be found on the inside cover of the Baby-OSCAR Site File

and on the underside of the Baby-OSCAR Documentation Box lid.

Select ‘Randomise baby’ from the menu and enter the relevant information from Section A of Form 1.

o The baby is only recruited and randomised into the Baby-OSCAR trial when you confirm the data you entered is correct.

o The randomisation program will then provide you with a 5 digit numeric ‘Study (ID) Number’ and 5-character alphanumeric ‘Trial Medication Pack ID’.

Check that the correct ‘Trial Medication Pack ID’ is available and unopened on the NICU. o If the package is missing contact the pharmacy to confirm that it has been

delivered to the NICU. o If it still cannot be located, or the package is open select ‘Allocate other pack’

from the main menu and the randomisation program will allocate a new ‘Trial Medication Pack ID’ number.

o If this package cannot be found, or is opened contact the Trial Co-ordinating Centre.

Before logging out print the randomisation details for the baby twice; one copy is to go into the baby’s clinical notes, and the other in the data collection file. Ensure that the following information is recorded:

o Study (ID) Number and Trial Medication Pack ID number in Section B of Form 1 o The baby’s Study (ID) Number in the space provided on the allocated package label o Baby’s initials and date of birth, on the trial medication pack o Date of the last dose in Section B of ‘Form 2: Trial Medication’ o Study Number on the Consent Form.

Form 1 should be completed and returned to the Trial Co-ordinating Centre in the FREEPOST envelope provided within 7 days of randomisation.

o Please remember to complete the Trial Participant Log in the Baby-OSCAR Data Collection File.

EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 2_Version 4.0 dated 23/08/18 Page 2 of 3

Prescribe the trial medication as soon as possible so that the first dose can be administered soon after randomisation after 6 hours of age, and within 72 hours of birth.

o Remember to record the date and time of all doses in Section B of ‘Form 2: Trial Medication’.

o The trial medication must be prescribed on the baby’s drug chart to be given intravenously once daily using the wording ‘Baby-OSCAR clinical trial medication, loading dose 2 ml/kg, maintenance doses two and three, 1 ml/kg, [enter 5-character alphanumeric value e.g. P1234]’.

o The Pack ID ‘P1234’ (1 letter, 4 digits) of the allocated package is an essential component of the prescription.

Randomisation Backup: If there are problems accessing the randomisation program during normal working hours, please contact the Trial Co-ordinating Centre on 01865 617 965. If outside normal working hours please use the out-of-hours contact procedure, as described in Guidance Sheet 7: Procedures for emergency queries.

For information on how to use the randomisation program please refer to the presentations in the ‘Neonatal Staff’ section of the Baby-OSCAR website (www.npeu.ox.ac.uk/baby-OSCAR).

EudraCT No: 2013-005336-23, REC Ref: 14/EM/0172 Guidance Sheet 2_Version 4.0 dated 23/08/18 Page 3 of 3

Guidance Sheet 2: Randomisation

Complete Part A of Form 1: Trial Entry

Do not randomise the baby into the study

If you experience problems with internet access or the randomisation program:

During normal office hours contact the Trial Office at the NPEU on 01865 617 965

If outside normal working hours please use the out-of-hours contact procedure described in Guidance Sheet 7: Procedures for emergency queries

Before logging out print the randomisation details for the baby twice; ensure that the following information is recorded:

i. Study (ID) Number and Trial Medication Pack ID number in Section B of Form 1

ii. The baby’s Study (ID) Number in the space provided on the allocated package label; Baby’s initials and date of birth on the trial medication pack

iii. Study (ID) Number on the Consent Form.

Prescribe and give the first dose of the medication from the allocated package as soon as possible (see Guidance

Sheet 3)

Complete Form 1 and return to the Trial Co-ordinating Centre within 7 days of randomisation using the

FREEPOST envelope. Remember to update the Trial Participant Log

YES

Is the baby eligible and has informed consent been obtained?

Access to the internet

NO

Experiencing technical difficulties

Log in to the randomisation website at:

https://rct.npeu.ox.ac.uk/babyoscar/

Login details can be found in the Baby-OSCAR Site File and Documentation Box

Enter relevant information from Part A of Form 1: Trial Entry

Confirm the data entered are correct

Randomisation is complete when a Study (ID) Number and Trial Medication Pack ID Number for the trial medication have been allocated