I-DSD/I-CAH/I-TS is approved by the National Research Ethics Service and Information Governance authorities in the UK. The information collected by the I-DSD/I-CAH/I-TS Registry is what is expected to be collected during routine clinical care and may be shared with approved users to perform or develop research studies. The Registry does not collect any information on names, addresses and local hospital numbers. Patients can also access their own information in the Registry and add patient reported outcomes. All information is kept strictly confidential and handled through secure password protected electronic systems and only those who are directly involved with the Registry are able to obtain access. All information is stored on a secure server in the University of Glasgow in compliance with the UK Data Protection Act (2018) and General Data Protection Regulation (GDPR 2016/679)
The following list contains documents that may be required by centres for obtaining local institutional approvals. Please contact us if you need a document that is not listed here.
- Ethical Approvals
- Conditions of Ethical Approval
- UK NHS IRB/Ethics application and Project Description
- Data Protection Approval Letter
- Data Access Policy
- Data Dictionary
- Data Flow in the Registry
- Data Sharing Agreement – Registry as Data Receiver (for centres adding patient data to the registry)
- Data Sharing Agreement – Registry as Data Supplier (for studies)
- Sample Participant Information Sheet – Adult, Child (further information sheets)
- Informed Consent Form
- Privacy Notice
The I-DSD/I-CAH/I-TS Registry is also on the UK NIHR Clinical Research Network Portfolio (Study Reference 12729).