Clinical Trial Site Assessment Form

Clinical Trial Site Assessment Form
Use this form to evaluate a clinical trial site’s readiness, capabilities, staffing, facilities, regulatory preparedness, recruitment potential, and overall suitability for trial participation.
Site Identification
Site Name
Site Address
Street Address
Street Address Line 2
CityState / ProvincePostal / Zip Code
Primary Contact Name
First NameMiddle NameLast Name
Primary Contact Role/Title
Primary Contact Email
example@example.com
Primary Contact Phone Number
Please enter a valid phone number.Format: (000) 000-0000.
Trial Experience and Capabilities
Number of Prior Clinical Trials Conducted
Therapeutic Areas of Experience
Other
Types of Clinical Trials Participated In
Notable Experience or Specialties
Staffing and Training
Principal Investigator Availability
Sub-Investigator Availability
Study Coordinator Availability
Pharmacy Support
Staffing and Training Status
Rows GCP Training Site-Specific Training Current Staffing Level
Principal Investigator
Sub-Investigator
Study Coordinator
Pharmacy Support
Laboratory Support
Regulatory Support
Regulatory Support
Facilities and Equipment
Clinic space availability
Exam room availability
Storage capacity for investigational products
Temperature monitoring capability
Other
Sample processing capability
Equipment availability and condition
Regulatory and Ethics Readiness
Ethics/IRB Approval Status
Available Regulatory Documents
Other
Available SOPs for Trial Conduct
Other
Source Documentation Readiness
Delegation Log Readiness
Ability to Maintain Essential Trial Records
Participant Access and Recruitment
Estimated monthly recruitment rate
Primary source of participants
Expected participant population and recruitment notes
Key inclusion/exclusion considerations affecting recruitment
Data Management and Quality Oversight
Electronic data capture / eSource use
Other
Internet access reliability
Primary query response workflow
Data entry responsibilities
Quality control practices
Other
Overall Site Assessment
Overall readiness rating
Key strengths
Key concerns
Follow-up actions required
Estimated activation timeline
Should be Empty:

Select theme:

Rows	GCP Training	Site-Specific Training	Current Staffing Level
Principal Investigator
Sub-Investigator
Study Coordinator
Pharmacy Support
Laboratory Support
Regulatory Support

Clinical Trial Site Assessment Form

Site Identification

Trial Experience and Capabilities

Staffing and Training

Facilities and Equipment

Regulatory and Ethics Readiness

Participant Access and Recruitment

Data Management and Quality Oversight

Overall Site Assessment