Clinical Trial Site Selection Checklist Form
Use this checklist to evaluate whether a clinical trial site is a strong fit for study activation and operations.
Site Identification
Site Name
*
Site Address / Location
*
Street Address
Street Address Line 2
City
State / Province
Postal / Zip Code
Please Select
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
The Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Brunei
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Cook Islands
Costa Rica
Cote d'Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Democratic Republic of the Congo
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Polynesia
Gabon
The Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kosovo
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Nagorno-Karabakh
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Turkish Republic of Northern Cyprus
Northern Mariana
Norway
Oman
Pakistan
Palau
Palestine
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
Portugal
Puerto Rico
Qatar
Republic of the Congo
Romania
Russia
Rwanda
Saint Barthelemy
Saint Helena
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
Somaliland
South Africa
South Ossetia
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard
eSwatini
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Transnistria Pridnestrovie
Trinidad and Tobago
Tristan da Cunha
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States
Uruguay
Uzbekistan
Vanuatu
Vatican City
Venezuela
Vietnam
British Virgin Islands
Isle of Man
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Other
Country
Primary Site Contact Name
*
First Name
Middle Name
Last Name
Primary Contact Email
*
example@example.com
Primary Contact Phone Number
*
Please enter a valid phone number.
Format: (000) 000-0000.
Study Fit and Site Capabilities
Therapeutic area match
*
Oncology
Cardiology
Neurology
Endocrinology
Infectious Diseases
Gastroenterology
Dermatology
Other
Experience with similar trial phase
*
Phase I
Phase II
Phase III
Phase IV
Bioequivalence
Device Study
Other
Patient population match
*
Pediatric
Adult
Older Adult
Women of Childbearing Potential
Healthy Volunteers
Disease-Specific Patients
Rare Disease Patients
Other
Can the site support the required visit schedule?
*
Yes
No
Partially
Operational Readiness
Staffing adequacy
*
Fully adequate
Adequate with minor gaps
Needs improvement
Not adequate
Principal investigator/sub-investigator availability
*
Fully available
Limited availability
Availability uncertain
Not available
Coordinator support
*
Dedicated coordinator in place
Shared coordinator support
Partial support available
No coordinator support
Pharmacy and laboratory access
*
Fully available onsite
Available via affiliate site
Available through referral/network
Not available
Equipment and technology readiness
EMR access
Internet/network access
Temperature monitoring equipment
Specimen storage equipment
Remote visit capability
Other
Anticipated activation timeline
*
Please Select
Immediately
Within 1 month
Within 2-3 months
Within 4-6 months
More than 6 months
Undetermined
Regulatory and Compliance Readiness
IRB / ethics review pathway in place
*
Yes
No
In Progress
GCP training status for key site staff
*
Completed
Partially Completed
Not Started
Required SOPs available and current
*
Informed Consent Process
Protocol Deviation Management
Adverse Event Reporting
Source Data Verification
Other
Site can maintain source documentation and audit readiness
*
Source Documents Stored Securely
Records Retained Per Policy
Audit Files Organized
Staff Available for Audit Support
Other
Facilities, Recruitment, and Final Review
Room Availability
*
Consultation room
Exam room
Infusion/treatment room
Procedure room
Other
Storage and Cold Chain Capacity
Ambient storage
Refrigerated storage
Frozen storage
Temperature monitoring
Backup power or alarm system
Not applicable
Other
Recruitment Feasibility and Patient Access / Retention Considerations
*
Overall Site Suitability Rating
*
Poor
1
2
3
4
5
6
7
8
9
Excellent
10
1 is Poor, 10 is Excellent
Final Reviewer Recommendation
*
Proceed
Proceed with conditions
Do not proceed
Submit Checklist
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