Trial documentation

The current documents being used as part of the SOLVE Trial are listed below:

Protocol v7.0 (includes Reference Safety Information and Trial Schema)

Case Report Forms:

Baseline and Birth Form v5.0

Treatment log v3.0

Screening log (electronic) v3.0

Product Defect Form v1.0

Eligibility & Randomisation Form v3.0

Questionnaire:

Maternal Satisfaction v3.0

Patient Facing Documents:

Patient Information Sheet (PIS) v4.0

Informed Consent Form (ICF) v2.0

Other Documents

Randomisation User Guide v8.0

Prescription Labels v5.0

GP letter (electronic) v1.0