Participant Safety and Medical Care
- Monitors participants closely for adverse events (AEs) and serious adverse events (SAEs).
- Provides or arranges appropriate medical care for study-related injuries.
- Ensures participants meet eligibility criteria to minimize risk.
- Ensures study procedures are justified and risks are reasonable in relation to anticipated benefits.
- Confirms participants understand the information and have time to ask questions.
- Adjusts treatment or withdraws a participant if continued participation could cause harm.
- Ensures qualified staff perform all trial procedures.
- Promptly reports SAEs and safety concerns to the sponsor, IRB, and regulatory authorities as required..
- Reviews safety data continuously and implements corrective actions when needed.
- Protects participant privacy and confidentiality.
- Ensures data are securely stored and only accessible to authorized personnel.
- Uses coded or anonymized data when possible.
- Risk Minimization
- Ongoing Safety Monitoring and Reporting
- Confidentiality and Data Protection
