Consent and recruitment
GHD, PIS
GHD
Children with I-GHD reversal under the care of a paediatric endocrinologist and/or a general paediatrician will be recruited from 12 UK and 5 Austrian centres. Administration of GH medication will be stopped for a minimum of 6 weeks prior to a GH re-test being performed in line with local protocols. If the patient is thought to be eligible after GH retesting, the clinical team will send the participant information sheet (PIS) to the patients’ parent/guardian, and they will be invited into clinic to discuss potential participation in the trial. It will be the responsibility of the principal investigator (PI) or their delegate to ensure written informed consent is obtained for each participant and/or parent/guardian prior to performing any trial-related procedures. The responsibility for obtaining consent may be delegated by the PI to another clinician as captured on the GHD Reversal Trial site signature and delegation log. If the potential participant and/or parent/guardian are willing to take part in the trial (and meet all of the eligibility criteria), they will be asked to sign and date the latest version of the GHD Reversal Trial informed consent form (ICF) and Assent Form if appropriate and the child will be randomised to one of the study arms. The participant and/or parent/guardian will give explicit consent for the regulatory authorities, members of the research team and or representatives of the sponsor to be given direct access to the participant’s medical records as required. This will be specified on the ICF.We will request consent for review of participants’ medical records and for the collection of blood samples to assess serum IGF-1 and lipid profiles (fasting lipids − serum triglyceride and serum total cholesterol) and peak stimulated GH.