Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT05141318
Eligibility Criteria:
Inclusion Criteria:
Patients:
* Patients of any age
* Ability to read English or Welsh (where age-appropriate).
* Capacity to give written informed consent, or assent for their family member to participate
* Attending ATMP treatment centre with a family member/carer.
* Being considered for, or have recently received, ATMP therapy for any diagnosed condition.
Family Members:
* Considered by the patient to be the person most affected by the patient's condition
* Adult family members aged 18 years or older.
* A family member or partner, living with or caring for, a patient who is being prepared to receive ATMP treatment or has recently received ATMP therapy for any diagnosed condition.
* Have capacity to give written informed consent and complete the interview and questionnaires.
Exclusion Criteria:
Patients:
* Adult patients: Lacking capacity, or unwilling to give written informed consent for their family member to participate.
* Gillick competent paediatric patients: unwilling to give written informed assent and/or consent for their family member to participate.
* Non-Gillick competent paediatric patients: patient's parent/guardian refuses to give consent or is unable to give consent on their behalf.
* Not being prepared for ATMP therapy, or is currently receiving ATMPs.
Family Members:
* Family members under 18 years of age.
* Not considered by the patient to be a family member or carer.
* Lacking capacity or willingness to give informed written consent to participate
* Having a severe handicap or disability that prevents the completion of interview and questionnaires.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05141318
Study Brief:
Protocol Section:
NCT05141318