HREC - Submission Documents
Standard Operating Procedures
Checklists
CV formats
Documentation
- Amendment form
- Trial/Study progress report
- Template for reporting of serious adverse events
- Template for line listing of adverse events and serious adverse events of MRC-approved protocols
- Guidance on how to apply for waiver of parental consent
Supporting documents
- Guidance on drawing up information sheets for human research projects
- Data storage
- Anthropometric measurements in children
- Guidance document on issues in research involving minors
- General hints and tips when submitting a protocol to the MRC Ethics Committee.
- Distress protocol
- Reimbursement of participants: NHREC information
- Clinical Trial Participant Time, Inconvenience & Expense (TIE) Compensation Model
- Application form for non-therapeutic research with minors
- WHO guidelines on paediatric and neonatal blood sampling