Research Study Clinical Trial Participant Subject Investigator Protocol Design Methodology Procedures Intervention Treatment Placebo Randomization Blinding Dose Route Control Experiment Observation Consent Agreement Voluntary Understanding Documentation Comprehension Decision Participation Explanation Information Disclosure Counseling Rights Autonomy Risks Benefits Alternatives Withdrawal Privacy Confidentiality 21 CFR 50.25 FDA Regulations Guidance Compliance Ethics Legal IRB Oversight Safeguards Protection Review Approval Monitoring Reporting Form Purpose Objective Hypothesis Procedure Evaluation Safety Efficacy Testing Data Collection Analysis Follow-Up Screening Inclusion Exclusion Enrollment Recruitment Site Duration Timelines Risk Assessment Adverse Events Side Effects Risk-Benefit Potential Direct Benefit Indirect Mitigation Well-being Anonymity Secure Storage Sharing Use De-identified Security Encryption Identity Standard Care Usual Diagnosis Medical Therapy Medication Support