Study Conduct Overview

The following information is for healthcare professionals only. If you are a potential PALomino study patient, please click here.

US

Syneos Health will act as the Coordinating Center and will oversee the conduct of the study in the US. The Coordinating Center will obtain central institutional review board (IRB) approval in accordance with US Code of Federal Regulations (CFR) 21 CFR 56.109 and 45 CFR 46.117(c)(2).

The Coordinating Center will obtain or collect the informed consent from eligible patients and will interact with the patient’s and the patient’s baby’s HCPs to collect the study data.

The patient contacts the Coordinating Center directly. The Coordinating Center will either consent the patient verbally or provide the Informed Consent Form (ICF) to the patient via mail or email at their request. In addition, the patient will be asked to complete the Medical Information Release Form (MIRF) process either verbally or in writing. The MIRFs will allow the Coordinating Center to contact the patient’s HCPs (e.g., PKU-treating physician, Obstetrician, Pediatrician) to confirm baseline information at the time of enrollment and to collect follow-up information during the pregnancy and through 1 year after the baby’s birth. All patient and HCP contact information will be confidential.

Once the patient is enrolled in the study, the Coordinating Center will contact the appropriate HCP (e.g., PKU physician, Obstetrician, Pediatrician) to request the data elements of interest collected in the study. The HCP may provide this information over the phone, or the Coordinating Center can provide study worksheets for the HCP to complete. The Coordinating Center will then enter the patient information into the study database.
If the Coordinating Center receives information that is not clear, the applicable HCP will be contacted to provide clarification. This may be done over the phone or via email.

EU

In each participating country, a Coordinating Registry Physician (CRP) will be selected as the primary physician providing oversight of the study in their respective country. The CRP will be responsible for obtaining Ethics Committee (EC) and any other applicable regulatory/country specific approvals along with communicating directly with regional HCPs about the study.

Patients or HCPs interested in learning more about the study will contact the country level CRP. In some countries, verbal consent may be allowed if acceptable per local guidance and regulations. The country specific CRP should be contacted for more information.

Once the ICF has been signed, the CRP will enroll the patient in the study.

Once the patient is enrolled in the study, the CRP will contact the appropriate HCP (e.g., PKU physician, Obstetrician, Pediatrician) to request the data elements of interest collected in the study. The HCP may provide this information over the phone or the CRP can provide study worksheets for the HCP to complete. The information will then be entered in the study database.

If the CRP receives information that is not clear, the applicable HCP will be contacted to provide clarification. This may be done over the phone or via email.