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> Clinical research site qualifications checklist
Clinical research site qualifications checklist
Site Qualification Checklist for Clinical Research
Site Infrastructure
- Ensure access to facilities suitable for conducting research studies
- Confirm availability of necessary equipment and supplies for study procedures
- Verify access to technology needed for data collection and storage
Access to adequate facilities for study conduct
Availability of appropriate equipment and supplies
Access to necessary technology for data collection and storage
Personnel Qualifications
- Verify qualifications of Principal Investigator
- Confirm availability of trained study coordinators and staff
- Ensure sufficient staff members to support study activities
Presence of qualified Principal Investigator
Availability of trained study coordinators and staff
Adequate number of staff members to support study activities
Regulatory Compliance
- Review documentation of IRB approval for study protocols
- Confirm compliance with Good Clinical Practice guidelines
- Ensure adherence to FDA regulations for clinical research
Documentation of IRB approval for study protocols
Compliance with Good Clinical Practice guidelines
Adherence to FDA regulations for clinical research
Patient Population
- Verify access to appropriate patient population for study enrollment
- Confirm ability to recruit and retain study participants
- Ensure experience working with diverse patient populations
Access to appropriate patient population for study enrollment
Ability to recruit and retain study participants
Experience working with diverse patient populations
Data Management
- Confirm availability of secure data storage and management systems
- Verify implementation of data quality control measures
- Ensure ability to generate accurate and timely study reports
Availability of secure data storage and management systems
Implementation of data quality control measures
Ability to generate accurate and timely study reports
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