ENSURED
Research type
Research Study
Full title
A European non-interventional study to understand the criteria used and the time required for the clinical diagnosis in participants with refractory epilepsies associated with developmental delay.
IRAS ID
274369
Contact name
Sameer Zuberi
Contact email
Sponsor organisation
Zogenix International LTD
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review). The identified local site staff (or trained independent data abstractors, if requested by the site) will review the medical records of all participants meeting the eligibility criteria, who have provided a signed informed consent form (ICF) or an assent form for data collection and analysis. For participants who are less than 18 years of age, in addition to the assent form being signed by the participant, an informed consent would be obtained from parent legally authorized representative (LAR).
The data collection will consist of three parts:
1- Site specific data to assess site characteristics which will be collected only once at the time of site activation.
2- Participant information/data will be collected in electronic case report form by reviewer of medical record by the investigator or his/her delegate.
3- For participants attending the site spontaneously during the course of the study, the data will be updated with the most recent clinical status.
The participant will attend the study site only at a routine clinic visit for the ICF and assent form procedures and for integration of medical records with most recent clinical status and current treatment status. For participants not attending routinely at the site, ICF or assent form will be obtained remotely (where permitted) and only data from medical records already available will be collected.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0375
Date of REC Opinion
17 Mar 2020
REC opinion
Further Information Favourable Opinion