Trial Documentation

Please use the links below for the current protocol:

ECUSTEC Protocol v5.0 (24th June 2019)

 

ECUSTEC PIS/GP Letters/Consent Forms
Please use the links below for copies of the following forms:

ECUSTEC Parent Information Sheet v5.0 (24th June 2019)

GDRP Addendum to ECUSTEC PIS V1.0 110319

ECUSTEC Patient 16_18 Information Sheet v5.0 (24th June 2019)

GDRP Addendum to ECUSTEC 16_18yrs PIS V1.0 110319

ECUSTEC Younger Child Information Sheet v1.0 (7th Sep 2016)

ECUSTEC Older Child Informaton Sheet v2.0 (18th January 2018)

ECUSTEC Parent Consent Form v5.0 (24th June 2019)

ECUSTEC Patient 16_18 Consent Form v5.0 (24th June 2019)

ECUSTEC Assent Form v2.0 (20th April 2017)

ECUSTEC Initial Letter to GP v1.0 (7th Sep 2016)

ECUSTEC Day 60 letter to GP v1.0 (7th Sep 2016)

 

Please use the links below for copies of the following letters:

ECUSTEC Letter for Patient Identification Centres Parent v2.0 (18th January 2018)

ECUSTEC Letter for Patient Identification Centres 16_18 or Older Child v2.0 (18th January 2018)

 

Please use the links below for copies of the following documents:

ECUSTEC Parent Thank you Letter v1.0 (7th Sep 2016)

ECUSTEC Younger Child Thank you Card v1.0 (20th March 2017) - For more copies of these please contact the BCTU trials office.

ECUSTEC Older Child Thank you Letter v1.0 (7th Sep 2016)

ECUSTEC Patient 16_18 Thank you Letter v1.0 (7th Sep 2016)

ECUSTEC Patient Study Card v1.0 (7th Sep 2016)

ECUSTEC Meningitis Warning Card  V3 July 2017

ECUSTEC Stool Sample Collection Guide v1.0 (7th Sep 2016)

ECUSTEC Parent Trial Evaluation Questionnaire v1.0 (7th Sep 2016)

ECUSTEC Patient 16_18 Trial Evaluation Questionnaire v1.0 (7th Sep 2016)

ECUSTEC Older Child Trial Evaluation Questionnaire v1.0 (7th Sep 2016)

ECUSTEC Meningococcal Day 30 Letter Over 2 yrs v1.0 (7th Sep 2016)

ECUSTEC Meningococcal Day 30 Letter Under 2 yrs v1.0 (7th Sep 2016)

ECUSTEC Meningococcal Day 30 Letter 16_18 yrs v1.0 (7th Sep 2016)

 

Please use the links below for copies of the following worksheets:

Audiometric Assessment v1.0 (6th Oct 2017)

Central Nervous System Assessment v1.0 (6th Oct 2017)

CNS Day 60 Assessment Letter to Paediatrics  Neurologist v1.0 (23rd Nov 2017)

Eye Examination v1.0 (6th Oct 2017)

Neuropsychological Assessment v1.0 (6th Oct 2017)

 

Please use the links below for copies of the following forms:

Randomisation Form v3.0 (24th June 2019)

Baseline Form v2.0 (27th Aug 2018)

Treatment Form 1 v2.0 (27th Aug 2018)

Treatment Form 2 v2.0 (27th Aug 2018)

Initial Admission for Trial Treatment Form v3.0 (20th Aug 2019)

30 Day Follow-up Form v2.0 (27th Aug 2018)

60 Day Follow-up Form v2.0 (27th Aug 2018)

26 & 52 Week Follow-up Form v2.0 (27th Aug 2018)

Healthcare Contacts Form v2.0 (27th Aug 2018)

Pregnancy Notification Form v1.0 (29th June 2017)

Serious Adverse Event Form v2.0 (27th Aug 2018)

Stool Sample Result Form v2.0 (27th Aug 2018)

Exit Form v3.0 (22nd Mar 2019)

ECUSTEC Day 1 Certificate of Vaccination v3.0 (28th March 2018)

ECUSTEC Day 8 Certificate of Vaccination v3.0 (28th March 2018)

ECUSTEC Pre discharge Certificate of Vaccination v3.0 (28th March 2018)

Please contact us for copies of the following forms (we cannot add these questionnaires to the website for download as they are copyright protected):

ECUSTEC ABAS Questionnaire 0-5yrs

ECUSTEC ABAS Questionnaire 5-21yrs

Child Health Utility (CHU) 9D Under 5yrs

Child Health Utility (CHU) 9D 5yrs and Over

Paediatric Quality of Life Inventory (Parent Report for Infants ages 1-12 months) PedsQL

Paediatric Quality of Life Inventory (Parent Report for Infants ages 13-24 months) PedsQL

Paediatric Quality of Life Inventory (Parent Report for Toddlers ages 2-4 yrs) PedsQL

Paediatric Quality of Life Inventory (Parent Report for Young Children ages 5-7 yrs) PedsQL

Paediatric Quality of Life Inventory (Parent Report for Children ages 8-12 yrs) PedsQL

Paediatric Quality of Life Inventory (Parent Report for Teens ages 13-18 yrs) PedsQL

Please ensure you use the correct form for the age of the patient.