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National Institute of Dental and Craniofacial Research
Clinical Research Operations and Management Support
Pre-Visit Site Assessment Questionnaire
Completion Instructions
Please provide the information requested in this questionnaire. If a section
or specific question is not applicable, mark the N/A box or write in N/A.
Date Completed:
Site PI:
Site Name:
Address(es):
Study Coordinator:N/A, specify
reason:
Back-up Study
Coordinator:
N/A
NIDCR Protocol
Number:N/A
Other Protocol
Number Used by this
Site:
N/A
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Site Contact Information
Principal Investigator:N/A
Name:Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:E-mail Address:
Primary Contact for Site Communication:N/AName:Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:
E-mail Address:Study Coordinator:N/AName:Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:E-mail Address:
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Pharmacist: N/AName:Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:E-mail Address:
Test Article Shipment/Receipt:N/A
Name:Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:E-mail Address:
All Other Study Supplies:N/A
Name:Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:E-mail Address:
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Regulatory Manager:N/AName:Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:E-mail Address:
Central Unit Manager:N/AName:
Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:E-mail Address:
Data Manager or Data Entry Staff:N/AName:Official Address:
Daily Address, if different than above:
Street Address for Overnight Mail, if different than above:
Phone Number:Fax Number:E-mail Address:
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Investigator and Staff Qualifications/Site Experience
N/A
Where is the study being conducted?
Name of location:
Dental clinic
Outpatient setting, communitybased
Outpatient clinic, hospitalbased
Inpatient unit, please describe:
Other, please describe:
What is the research teams therapeuticspecialty(ies)?
Does the Principal Investigator haveprevious experience with:
Clinical Research?
Study Therapeutic Area?
Study Subject Population?
Test Article/ Similar Product
Similar Research Studies?
N/A
Yes Number of Studies:_____No
Yes Number of Studies:_____No
Yes Number of Studies:_____No
Yes Number of Studies:_____No
Yes Number of Studies:_____No
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Does the Study Coordinator haveprevious experience with:
A. Clinical Research?
Study Therapeutic Area?
Study Subject Population?Test Article/ Similar Product
Similar Research Studies?
N/A
Yes Number of Studies:_____No
Yes Number of Studies:_____No
Yes Number of Studies:_____No
Yes Number of Studies:_____No
Yes Number of Studies:_____No
What percentage of prior studiesconducted by the site met enrollmentgoals and timelines?
If less than 100%, describe whythe goals and timelines were notmet:
N/A
_____%
How many studies are the PI and sitepersonnel currently conducting with this
population?
N/A
____ Total number Open andEnrolling
____ Total number in Follow-upPhase
Does the PI and site personnel havesufficient time to:
A. Conduct the study?
Be available for monitoring
visits?Attend study meetings?
Yes No
Yes NoYes No
Will a licensed dentist or clinician beavailable on-site for study-related dentalor medical decisions?
Yes No
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Has the investigator(s) and/or site everbeen inspected by a regulatory agency?
If Yes, when was the inspection
done and by what agency?Specify who was inspected, PI orsite.
Yes No
Study Populations and Accrual Goals
N/A
1. Does the site intend to advertisefor clinical study subjects?
Yes No
What languages are spoken in the target
community from which subjects will bescreened for participation?
Languages Spoken:
A.
B.
C.
Percentages of PopulationRepresented:
___% of Gen.Pop.
___% of Gen.Pop.
___% of Gen.Pop.
___% of TargetScreening Pop.
___% of TargetScreening Pop.
___% of TargetScreening Pop.
Do the investigator and site personnelhave adequate language capabilities forcommunication with the targetcommunity?
Yes No
Will informed consents, handouts, oradvertisements be required in additionallanguages?
If Yes, describe how thedocuments will be translated:
Yes No
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Are there any foreseeable obstacles toenrollment, such as conflicts of interest,site issues, or other enrolling studies?
Yes No N/A
When will the site conduct studyscreening and other protocol requiredvisits?
Can subjects reach sitepersonnel at all times?
Days/Hours of Visits:
Yes No
Protocol and Study Design
1. Do you or any of your staffrequire additional training onthe protocol or studyprocedures in the followingareas?
If Yes, indicate areas:
Yes No N/A
A. Study objectives? Yes No
Inclusion/exclusion criteria? Yes No
Study procedures includingparticipant follow-up?
Yes No
Participant completion/Early
termination?Yes No
Laboratory procedures? Yes No
Processing and/or shipping of
biological specimens?Yes No
AE/SAE reporting and
management?Yes No
Investigator/staff
responsibilities? Yes No
Investigators Responsibility
for Protocol Conduct
(delegation of tasks,
participant safety, protocol
compliance, participant
confidentiality)?
Yes No
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Clinical Monitoring
1. Will the study PI and staff bewilling to allow a monitor (CRA) to
come at least one time per yearto ensure the protection ofhuman rights (review of informedconsents) and adherence to theprotocol?
Yes No
Will the monitor have adequate workspaceto conduct the visit?
Yes No
Will the monitor have access to themedical records (paper and electronic) so
that adequate review of sourcedocumentation can be completed duringthe visit?
Yes No
Which source documents are usually keptin the participants medical record?
Informed consent
Progress notes
Medical history
Clinical reports (e.g., lab, X-ray, ECG)
Study specific worksheetsOther, specify:
Facilities and Equipment
N/A
1. Is there adequateexamination/procedure roomspace to conduct assessmentsas specified in the protocol?
Yes No
Is there access to emergency equipmentand facilities?
Yes No
Please describe the site emergency response plan:
Are the specific types of clinicalequipment needed for this study
Yes No N/A
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available and adequately maintained?
4a. List the protocol specific clinical equipment available and themaintenance schedule:
Does the staff have adequate space fordata entry/management?
Yes No
Is there on-site access to the followingequipment for both staff and CRAs:
A. Telephone?
Fax machine?
Copier
Computer with internet
access for eCRF monitoring(if applicable) or internet
availability?
Yes No
Yes No
Yes No
Yes No
Will the CRA have adequate work spacefor monitoring activities?
Yes No
Does the site have adequate, securestorage for study records?
Yes No N/A
Where are the study source documents
and are paper CRFs stored during studyconduct?
Location of Source Documents:
Location of Paper CRFs:
Are the source documents, includingmedical records, paper or electronic?
Paper Electronic
If electronic, will the CRA have access tothem?
Yes No
If paper CRFs are being used, are theylocated off-site, outside the site/clinic?
If Yes, describe the frequencyand method for transporting thedata to the off-site location:
Yes No N/A
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Laboratory
N/A
1. Will the CRA have access to theclinical laboratory
facilities/equipment?
Yes No N/A
Are the specific types of clinicallaboratory equipment needed for thisprotocol available and maintainedproperly?
Yes No N/A
Describe the equipment present for processing specimens for transfer tolaboratory facility:
Who collects clinical specimens and how are they handled prior to transfer to
a laboratory facility?
How and when are samples transferred from:
5a. Clinical site to clinical laboratory(ies)?
5b. Clinical site to research laboratory(ies)?
Is the trial site using a central/corelaboratory?
If Yes, complete the following:
A. Name of central/core laboratory:
Purpose of the laboratory?
IATA certification present for
all site staff who will
handle/ship hazardous
materials
Known difficulties/barriers
with shipment from this site?
Has this site previously
worked with a central/corelaboratory?
Yes No N/A
Name:
Clinical safety Research
specimen
Yes No
Yes No
Yes No
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Is the site using a local laboratory(ies) forclinical testing?
If Yes, complete the following:
A. Name of local clinical lab forsafety testing:
Is the lab qualified/certified
to perform procedures for
the study?
Are the following available
for review:
Lab certification?
Lab normal ranges?
Yes No N/A
Name:
Yes No
Yes No N/A
Yes No N/A
Is the trial site using a locallaboratory(ies) for research specimenpreparation and storage?
If Yes, complete the following:
A. Name/location of local lab
performing specimen
preparation, storage, and/or
shipping:
List the storage equipment,security procedures,
temperature monitoring
procedures, backup power
supply, etc.:
Contact person(s) for
specimen preparation,
storage, and/or shipping:
Yes No N/A
Name:
Location:
Storage, security, temperature
monitoring, backup:
Contact person(s):
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Is the trial site using a locallaboratory(ies) for research specimenanalysis?
If Yes, complete the following:
A. Name/location of local lab
performing on-site analysis:
Protocol-related tests to be
conducted by this facility:
Is staff available to perform
protocol-related procedures?
Contact person(s) for
research lab
Are lab certification,
reference values, and qualitycontrol procedures available
for review?
Are standard written policies
and procedures for daily
running/maintenance of lab
equipment available?
Describe the method to
ensure refrigerator/freezer
temperatures are maintained
within required ranges during
normal work hours and
procedures in the event of
power outage or mechanical
problem.
Yes No N/A
Name:
Location:
Tests:
Yes No
Contact person(s):
Yes No
Yes No
Description:
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If your site is outside the United States,please answer the following questionsabout clinical laboratory(ies):
A. Does it have national or
international certification?List the certification (if
available)
Does the lab perform quality
control procedures and
maintain copies of the
testing results?
Does the lab maintain copies
of the analyte reference
value?
N/A
Yes No N/A
Certification:
Yes No N/A
Yes No N/A
Have protocol-specific lab requirements(specific collection/storage tubes,labeling, storage temperatures, shippingschedule, etc.) been discussed with thelaboratory(ies)?
Yes No N/A
Study Product/Study Supplies
N/A
1. Is there adequate storage fortest article in accordance withthe protocol, ICH, GCP, andnational laws or regulations, and(if applicable) internationalhealth and safety agreements?
Yes No
From where will the test article be storedand dispensed?
Pharmacy
Nursing Station
Clinic
Off-site FacilityOther, specify:
Describe security measures related to test article.
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Do(es) the storage area(s) meetrequirements such as temperaturemonitoring, protection from light, andhumidity?
Yes No N/A
Describe storage location(s)/equipment, mechanism for temperaturemonitoring, backup power supply, etc.
If an off-site facility is used, describe procedures to transport test articles tothe off-site facility, maintenance of test article at the appropriatetemperature (cold chain), storage prior to dispensing, test articleaccountability, return of unused test article to the pharmacy, etc.:
Have dispensing and transportprocedures been discussed with thestudy personnel and/or pharmacypersonnel?
Yes No
Are the study personnel and/orpharmacy personnel familiar with testarticle accountability documentation?
Yes No
Who will administer the test article?
Data Management N/A
1. Describe the data collection process at the site (i.e. Clinical data flow,how data is collected, who completes CRFs, and, if applicable, whodoes data entry of eCRFs.)
Is the sites research-specific electronicdata management system 21 CFR Part11 compliant?
Yes No N/A UNK
Who at the site has the responsibility for:
A. Overall clinical data management (Name/Title):
On-site data analysis process (Name/ Title):
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Is there a site management groupresponsible for data review or analysis?
Yes No N/A
Is a Data Coordinating Center (DCC) usedfor this protocol?
If Yes, list the name
Yes No N/A
Name:
Are hospital/clinic records paper-based orelectronic?
A. If electronic or both paper and
electronic, describe the medical
records system and how these
records will be provided for
review by the CRA.
If paper-based, which recordswill be available for CRA
review?
Paper-based Electronic
Both
Description:
Clinic/hospital Research
chart
If electronic information/data is used, describe general security andconfidentiality measures.
Are clinic/hospital medical record storagefacilities located near the trial site?
Yes No N/A
Which source documents are usuallykept in the subjects medical record?
Informed consentProgress notes
Medical History
Clinical Reports (e.g. lab, X-ray,ECG)
Study-specific worksheets
Other
Describe the adverse event and/or unanticipated problem data flow, including:
collection, review for causality, relatedness, intensity /grading, who completesthe SAE form, related CRFs and if applicable, data entry into eCRFs.
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Does the site have an SAE reportingsystem?
If Yes, describe who isresponsible for notifying the
Independent Safety Monitor,IRB, Sponsor/NIDCR, and thechain of events.
Who has primary and secondaryresponsibility for reviewing andsigning SAE reports?
Yes No
Description:
Primary:
Secondary:
Describe the site procedures for SAE reconciliation between the safety andclinical databases, if applicable.
Is long-term storage for study records(after study close-out) maintained off-site?
If Yes, describe any specialprocedures for records review.
Yes No
Description:
Site Management
N/A
1. Who is responsible for the day-to-day management of the site?
Name/Title:
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Does the site have a written QualityManagement Plan (QMP)?
If Yes:
A. Has the QMP plan beenimplemented?
Was a copy provided to the
NIDCR?
Date QMP was written or last
reviewed:
Who has responsibility for
the day-to-day
implementation of the QMP?
If No:
A. Does the site currently perform
QM procedures?
If Yes, describe the current
QM process:
Describe the communication
methods available at this
site.
Yes No UNK
Yes No UNK
Yes No UNK
Date:
Name/Title:
Yes No UNK
IRB/IEC and Regulatory Requirements
N/A
1. Who is responsible for maintenance of the sites regulatory files?
Name/Title:
List the IRB/IEC(s) that the site expects to use on this study.
IRB/IEC:
How frequently does the IRB/IEC meet?
What is the date of the IRB/IEC meeting at which the protocol may beconsidered?
What is the expected timeframe between meeting and issue of writtenapproval by the IRB/IEC?
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Are there any obstacles to timely IRB/IECapproval?
If Yes, explain obstacles.
Yes No
Will submission to additional sitecommittees (e.g. Research, Bio-Safety)be required?
A. If Yes, list the names of the
committees and any anticipated
time constraints.
Do submissions need to be
completed in a certain order?
If Yes, provide the order:
Yes No
Name:
Yes No
Does the sites IRB/IEC have aFederalwide Assurance (FWA)?
Yes No
Documentation of Policies and Procedures
N/A
1. Does the site have writtenSOPs/procedures for clinicalresearch?
If Yes, what SOPs does the site
have?
Yes No
Does the site have a copy of the IRB/IECpolicy concerning investigatorobligations?
Yes No
Training N/A
1. Has the staff received trainingon ICH, GCP, and applicableregulatory training?
Yes No
Has the site staff completed the requiredHuman Subjects Protection Training?
Yes No
Have key site personnel received trainingon NIDCR Investigator obligations forclinical research?
Yes No
Web-cast Investigators
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A. If Yes, how were they trained?
If Yes, when was the training
completed?
Meeting On-site training
Training date:
Has the staff identified any additional
training needs for site personnel?A. If Yes, list training needs:
Yes No
Are training records maintained for studystaff, both general and study specific?
Yes No
International Sites N/A
1. Can the Principal Investigatorand other site personnelcommunicate with the CRA inEnglish during monitoring visits?
If No, describe method forworking with an Englishspeaking CRA:
Yes No
In which language(s) are the followingdocuments written?
A. CRFs
Source Documents
Regulatory Documents
English Other:
English Other:
English Other:
Is the consent process conducted inEnglish?
If No, identify the language(s):
Yes No
Describe the method of obtaining Informed Consent:
Is there a written document, oral description, or other procedure?
Who will conduct the consent process?
Are all subjects literate?
If No, identify the procedure forobtaining and documentingInformed Consent, includingwhether a short oral InformedConsent Form is available:
Yes No
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Are there local customs of which NIDCRshould be made aware:
If Yes, describe:
Yes No
Is there a community advisory board? Yes No
Does the community leader, or village ortribal chief understand and support thestudy?
Yes No
Describe how the community has been engaged in the research process:
Are there any country-specific
requirements or potential difficulties thatmight interfere with regulatory approvalsor subject enrollment?
If Yes, please describe:
Yes No
Conclusion
Additional Comments: None
___________________________________
________________________
Name/Title of person completing questionnaire Date
(dd/mmm/yyyy)