How should the Consent Form be completed?
The parent/guardian must complete the Consent Form. The parent/guardian should initial against each item 1-8. N.B. initials must be used, ticks aren’t acceptable. The parent must print and sign their name and date the Consent Form. The researcher must print and sign their name and date the Consent Form. When the patient is randomised the PREDNOS Study Number should be added to the Consent Form.
The parent does not want the child to give a blood sample can they still be included in the study?
Yes, it is perfectly acceptable for a child to take part in the PREDNOS trial but not give a blood sample. To indicate that the parent does not consent to a blood sample being taken from the child, the parent should not initial against item 7 on the Consent Form.
When should randomisation take place?
It is anticipated that the large majority of study patients will be recruited and randomised on or shortly after day 21 of initial open label therapy. This will:
i. allow Principal Investigators a sufficient period of time to recruit the patient
ii. allow parents adequate time to provide fully informed consent
iii. allow a sufficient time to have passed to ensure that steroid sensitivity will have been established in the majority (median time to response is 10-14 days).
iv. allow BCH pharmacy enough time to make up the study treatment blister pack and send to the patient’s home address so as randomised treatment can start at Week 5 (day 29).
How should the Prescription Form be completed?
The Prescription Form must be completed in full and signed before it is faxed to the Birmingham Children’s Hospital (BCH) Pharmacy, including the PREDNOS Study Number, Date of Randomisation and Date Study Medication Due to Start (this information is given when the patient is randomised). If any sections are not completed this could delay the dispatch date of the Study Medication. Please also ring BCH Pharmacy to confirm they have received the fax and post signed Prescription Form and Consent/Assent Form to BCH Pharmacy. All fax, tel and address details are included on the Prescription Form.
Where is the Consent Form sent?
The Consent Forms should be sent to Birmingham Children’s Hospital pharmacy, initially by fax and followed by a hard copy in the post, together with the Prescription Form. Please do not send the Consent Form to BCTU. The original copy of the consent/assent form should be kept in site file, one copy given to parent/patient, one copy for hospital notes (and one copy for Birmingham Children’s Hospital pharmacy).
How long should daily testing of urine continue for?
In routine clinical practice, we recommend that parents test their child’s urine on a daily basis, and this should be the recommendation for the trial. We are, of course, aware that in routine clinical practice parents don’t always do this, particularly where their child has been well and in remission for a long period – often here they only test the urine two or three times a week, with more focussed testing at the time of upper respiratory tract infections etc. So in short, we should recommend daily testing for the duration of the study, but accept that this will be likely to wane with time.
How should the blood collection materials be used?
If consent has been given blood will be collected into two 5ml EDTA containing blood tubes provided in the blood pack at some point during the first year of follow-up, preferably at the time of routine venepuncture for clinical purposes.
Samples should be labelled only with the patient’s study number and DOB (in mmm/yyyy format), thus maintaining strict anonymity. Samples can only be retained in a linked anonymised manner. Once collected, study sites should mail both blood samples to Dr Bockenhauer’s laboratory using pre-paid addressed packaging provided. See PREDNOS Protocol Section 4.20.2.
A PREDNOS samples log is provided in Section 4.10 of the Site File. Please note whether or not the patient/parent has consented to a blood sample being taken and if consent has been given, please note that date that the sample was taken and what date it was sent to Dr Bockenhauer.
Instructions for using the blood sample materials:
Unfortunately the syringes provided are for use in a vacutainer system, which is not generally used in paediatric practice. Furthermore, it is not possible to attach needles to the end of the syringes using a Luer lock system. Therefore we would be most grateful if you could collect the 10ml blood sample using whichever collection system is in routine use in your centre (e.g. syringe plus Butterfly) and put the sample into two standard 5ml EDTA containers. If your hospital does not have access to these, please let us know and we can forward these to you. Please label and place these EDTA containers into the screw top tubes to protect them in transport. Place the tubes in the cardboard box and post to GOS. The box is postage paid and pre-addressed.
How many tablet crushers are provided?
The Renal Trials Office at BCTU will provide one tablet crusher to each site initially. This will be sent to fully approved sites together with the Site File and Blood Sample Collection Pack before the Site Initiation. Once the centre has randomised a patient further tablet crushers will be provided on request.
Who supplies the Patient Diaries?
The Renal Trials Office at BCTU will provide the Patient Diaries, copies can be found in the Site File. Extra copies can be downloaded from:
Who supplies the Albustix?
These will be provided by Birmingham Children’s Hospital Pharmacy. A pot of Albustix will be sent together with Study Medication Blister Pack direct to the parent’s specified delivery address.
On what date should the Week 4 Assessment be completed?
The Week 4 Assessment is due 4 weeks (28 days) after the day the patient started open label treatment i.e. it is due on the same date as the patient is due to start study treatment (day 29). This is an important baseline assessment so should ideally be completed +/- 3 days from the due date. In exceptional circumstances it can be completed up to +/- 1 week from the due date.