Your checklists (
0
)
AI Checklist Generator
From the makers of
Manifestly Checklists
Sign in
Email address
Email me a magic link
Home
> clinical trial checklist
clinical trial checklist
Pre-trial Preparation
Identify the need for the clinical trial
Define the objectives and hypothesis
Develop the trial protocol
Obtain necessary approvals and permissions
Identify and select trial sites
Recruit and train investigators and site staff
Establish trial management and monitoring procedures
Develop data collection forms and case report forms (CRFs)
Obtain informed consent forms and documents
Trial Initiation
Conduct site initiation visits
Verify trial site readiness
Ensure necessary equipment and supplies are available
Train site staff on trial procedures and protocol
Randomize participants and assign treatment groups
Initiate participant enrollment
Trial Execution
Conduct participant screening and enrollment
Perform trial interventions and interventions
Collect and record trial data accurately
Monitor participant compliance and adherence
Ensure participant safety and welfare
Address and manage adverse events
Conduct interim data analysis, if necessary
Monitor trial progress and site performance
Ensure trial documentation is complete and up-to-date
Trial Closure
Complete participant follow-up and data collection
Conduct final data analysis
Prepare trial report and publication
Ensure data confidentiality and security
Archive trial documentation and records
Report trial results to relevant stakeholders
Conduct trial review and evaluation
Close trial sites and perform site closure visits
Regulatory and Ethical Considerations
Comply with applicable regulatory requirements
Obtain necessary ethical approvals and reviews
Ensure trial design and conduct adhere to ethical guidelines
Maintain participant confidentiality and privacy
Report serious adverse events promptly
Comply with data protection regulations
Quality Assurance and Control
Develop and implement quality control measures
Perform regular site monitoring and audits
Verify data accuracy and integrity
Address and correct non-compliance or deviations
Ensure trial conduct meets quality standards
Trial Documentation and Reporting
Maintain comprehensive trial documentation
Record all trial-related activities and events
Compile and submit trial progress reports
Prepare and submit final trial report
Archive trial documentation for future reference
Note: This checklist is a general guideline and may vary depending on the specific requirements and regulations of the clinical trial.
Download CSV
Download JSON
Download Markdown
Use in Manifestly
Use in Manifestly