site assessment questionnaire

8/3/2019 Site Assessment Questionnaire

1/21

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

Site Assessment Questionnaire v2.0 (04Apr2011) Page 1 of 21


2/21

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:



Phone Number:Fax Number:

E-mail Address:Study Coordinator:N/AName:Official Address:






3/21

Pharmacist: N/AName:Official Address:




Test Article Shipment/Receipt:N/A





All Other Study Supplies:N/A







4/21

Regulatory Manager:N/AName:Official Address:




Central Unit Manager:N/AName:

Official Address:




Data Manager or Data Entry Staff:N/AName:Official Address:






5/21

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







6/21

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






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



7/21

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.



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



8/21

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



9/21

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



10/21

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



11/21

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



12/21

Is the site using a local laboratory(ies) forclinical testing?


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?


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):



13/21

Is the trial site using a locallaboratory(ies) for research specimenanalysis?


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:



14/21

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.



15/21

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):



16/21

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.



17/21

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:



18/21

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?



19/21

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



20/21

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



21/21

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)