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: Back-up Study Coordinator: NIDCR Protocol Number: Other Protocol Number Used by this Site: N/A, specify reason: N/A N/A

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/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: Study Coordinator: 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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Pharmacist: 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: 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:

N/A

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Regulatory Manager: 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: Central Unit Manager: 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: Data Manager or Data Entry Staff: 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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Investigator and Staff Qualifications/Site Experience N/A Where is the study being conducted? Dental clinic Outpatient setting, community based Name of location: Outpatient clinic, hospital based Inpatient unit, please describe:

Other, please describe: What is the research teams therapeutic specialty(ies)? Does the Principal Investigator have previous 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 have previous 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 studies conducted by the site met enrollment goals and timelines? If less than 100%, describe why the goals and timelines were not met: How many studies are the PI and site personnel currently conducting with this population?

N/A _____%

N/A ____ Total number Open and Enrolling ____ Total number in Follow-up Phase

Does the PI and site personnel have sufficient time to: A. Conduct the study? Be available for monitoring visits? Attend study meetings? Will a licensed dentist or clinician be available on-site for study-related dental or medical decisions? Yes Yes Yes Yes No No No No

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Has the investigator(s) and/or site ever been inspected by a regulatory agency? If Yes, when was the inspection done and by what agency? Specify who was inspected, PI or site. Study Populations and Accrual Goals N/A 1. Does the site intend to advertise for clinical study subjects? What languages are spoken in the target community from which subjects will be screened for participation? Languages Spoken: A. B. C.

Yes

No

Yes

No

Percentages of Population Represented: ___% of Gen. Pop. ___% of Target Screening Pop. ___% of Target Screening Pop. ___% of Target Screening Pop. ___% of Gen. Pop.

___% of Gen. Pop.

Do the investigator and site personnel have adequate language capabilities for communication with the target community? Will informed consents, handouts, or advertisements be required in additional languages? If Yes, describe how the documents will be translated:

Yes

No

Yes

No

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Are there any foreseeable obstacles to enrollment, such as conflicts of interest, site issues, or other enrolling studies?

Yes

No

N/A

When will the site conduct study screening and other protocol required visits? Can subjects reach site personnel at all times? Protocol and Study Design 1. Do you or any of your staff require additional training on the protocol or study procedures in the following areas? If Yes, indicate areas: A. Study objectives?

Days/Hours of Visits:

Yes

No

Yes

No

N/A

Yes Yes Yes Yes Yes Yes Yes Yes Yes

No No No No No No No No No

Inclusion/exclusion criteria? Study procedures including participant follow-up? Participant completion/Early termination? Laboratory procedures? Processing and/or shipping of biological specimens? AE/SAE reporting and management? Investigator/staff responsibilities? Investigators Responsibility for Protocol Conduct (delegation of tasks, participant safety, protocol compliance, participant confidentiality)?

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Clinical Monitoring 1. Will the study PI and staff be willing to allow a monitor (CRA) to come at least one time per year to ensure the protection of human rights (review of informed consents) and adherence to the protocol? Will the monitor have adequate workspace to conduct the visit? Will the monitor have access to the medical records (paper and electronic) so that adequate review of source documentation can be completed during the visit? Which source documents are usually kept in the participants medical record? Yes No

Yes Yes

No No

Informed consent Progress notes Medical history Clinical reports (e.g., lab, Xray, ECG) Study specific worksheets Other, specify:

Facilities and Equipment N/A 1. Is there adequate examination/procedure room space to conduct assessments as specified in the protocol? Is there access to emergency equipment and facilities? Yes No

Yes

No

Please describe the site emergency response plan: Are the specific types of clinical equipment 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 the maintenance schedule:

Does the staff have adequate space for data entry/management? Is there on-site access to the following equipment for both staff and CRAs: A. Telephone? Fax machine? Copier Computer with internet access for eCRF monitoring (if applicable) or internet availability? Will the CRA have adequate work space for monitoring activities? Does the site have adequate, secure storage for study records? Where are the study source documents and are paper CRFs stored during study conduct?

Yes

No

Yes Yes Yes Yes Yes Yes

No No No No No No N/A

Location of Source Documents: Location of Paper CRFs:

Are the source documents, including medical records, paper or electronic? If electronic, will the CRA have access to them? If paper CRFs are being used, are they located off-site, outside the site/clinic? If Yes, describe the frequency and method for transporting the data to the off-site location:

Paper Yes Yes

Electronic No No N/A

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Laboratory N/A 1. Will the CRA have access to the clinical laboratory facilities/equipment? Are the specific types of clinical laboratory equipment needed for this protocol available and maintained properly? Yes No N/A

Yes

No

N/A

Describe the equipment present for processing specimens for transfer to laboratory 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. 5b. Clinical site to clinical laboratory(ies)? Clinical site to research laboratory(ies)? Yes No N/A

Is the trial site using a central/core laboratory? If Yes, complete the following:

A. Name of central/core laboratory: Name: Purpose of the laboratory? Clinical IATA certification present for specimen all site staff who will handle/ship hazardous Yes materials Yes Known difficulties/barriers Yes with shipment from this site? Has this site previously worked with a central/core laboratory?

safety No No No

Research

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Is the site using a local laboratory(ies) for clinical testing? If Yes, complete the following: A. Name of local clinical lab for safety testing: Is the lab qualified/certified to perform procedures for the study? Are the following available for review: Lab certification? Lab normal ranges? Is the trial site using a local laboratory(ies) for research specimen preparation 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: Yes Yes Yes No No No N/A N/A

Yes

No

N/A

Name: Location:

Storage, security, temperature monitoring, backup:

Contact person(s):

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Is the trial site using a local laboratory(ies) for research specimen analysis? 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 quality control 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 questions about 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? Have protocol-specific lab requirements (specific collection/storage tubes, labeling, storage temperatures, shipping schedule, etc.) been discussed with the laboratory(ies)? Study Product/Study Supplies N/A 1. Is there adequate storage for test article in accordance with the protocol, ICH, GCP, and national laws or regulations, and (if applicable) international health and safety agreements? From where will the test article be stored and dispensed?

N/A

Yes

No

N/A

Certification:

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

Yes

No

Pharmacy Nursing Station Clinic Off-site Facility Other, specify:

Describe security measures related to test article.

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Do(es) the storage area(s) meet requirements such as temperature monitoring, protection from light, and humidity?

Yes

No

N/A

Describe storage location(s)/equipment, mechanism for temperature monitoring, backup power supply, etc.

If an off-site facility is used, describe procedures to transport test articles to the off-site facility, maintenance of test article at the appropriate temperature (cold chain), storage prior to dispensing, test article accountability, return of unused test article to the pharmacy, etc.:

Have dispensing and transport procedures been discussed with the study personnel and/or pharmacy personnel? Are the study personnel and/or pharmacy personnel familiar with test article accountability documentation? Who will administer the test article?

Yes

No

Yes

No

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, who does data entry of eCRFs.) Is the sites research-specific electronic data management system 21 CFR Part 11 compliant? Who at the site has the responsibility for: A. Overall clinical data management (Name/Title): On-site data analysis process (Name/ Title): Yes No N/A UNK

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Is there a site management group responsible for data review or analysis? Is a Data Coordinating Center (DCC) used for this protocol? If Yes, list the name

Yes Yes Name:

No No

N/A N/A

Are hospital/clinic records paper-based or Paper-based electronic? Both A. If electronic or both paper and electronic, describe the medical Description: records system and how these records will be provided for review by the CRA. If paper-based, which records Clinic/hospital will be available for CRA chart review?

Electronic

Research

If electronic information/data is used, describe general security and confidentiality measures. Are clinic/hospital medical record storage facilities located near the trial site? Which source documents are usually kept in the subjects medical record? Yes No N/A

Informed consent Progress 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 completes the SAE form, related CRFs and if applicable, data entry into eCRFs.

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Does the site have an SAE reporting system? If Yes, describe who is responsible for notifying the Independent Safety Monitor, IRB, Sponsor/NIDCR, and the chain of events. Who has primary and secondary responsibility for reviewing and signing SAE reports?

Yes

No

Description:

Primary: Secondary:

Describe the site procedures for SAE reconciliation between the safety and clinical databases, if applicable. Is long-term storage for study records (after study close-out) maintained offsite? If Yes, describe any special procedures for records review. Site Management N/A 1. Who is responsible for the day-to-day management of the site? Name/Title: Yes No

Description:

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Does the site have a written Quality Management Plan (QMP)? If Yes: A. Has the QMP plan been implemented? 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. IRB/IEC and Regulatory Requirements N/A

Yes

No

UNK

Yes Yes Date:

No No

UNK UNK

Name/Title:

Yes

No

UNK

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 be considered? What is the expected timeframe between meeting and issue of written approval by the IRB/IEC?

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Are there any obstacles to timely IRB/IEC approval? If Yes, explain obstacles. Will submission to additional site committees (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: Does the sites IRB/IEC have a Federalwide Assurance (FWA)?

Yes

No

Yes

No

Name: Yes No

Yes

No

Documentation of Policies and Procedures N/A 1. Does the site have written SOPs/procedures for clinical research? If Yes, what SOPs does the site have? Does the site have a copy of the IRB/IEC policy concerning investigator obligations? Training 1. Has the staff received training on ICH, GCP, and applicable regulatory training? Has the site staff completed the required Human Subjects Protection Training? Have key site personnel received training on NIDCR Investigator obligations for clinical research? Yes No Yes No Yes No

N/A

Yes Yes

No No

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A. If Yes, how were they trained? If Yes, when was the training completed? Has the staff identified any additional training needs for site personnel? A. If Yes, list training needs: Are training records maintained for study staff, both general and study specific? International Sites 1. Can the Principal Investigator and other site personnel communicate with the CRA in English during monitoring visits? If No, describe method for working with an English speaking CRA: In which language(s) are the following documents written? A. CRFs Source Documents Regulatory Documents

Meeting

On-site training

Training date: Yes No

Yes

No

N/A Yes No

English English English

Other: Other: Other:

Is the consent process conducted in English? 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 for obtaining and documenting Informed Consent, including whether a short oral Informed Consent Form is available: Site Assessment Questionnaire v2.0 (04Apr2011) Page 20 of 21 Yes No

Are there local customs of which NIDCR should be made aware: If Yes, describe: Is there a community advisory board?

Yes

No

Yes

No

Does the community leader, or village or tribal chief understand and support the study?

Yes

No

Describe how the community has been engaged in the research process:

Are there any country-specific requirements or potential difficulties that might interfere with regulatory approvals or subject enrollment? If Yes, please describe: Conclusion Additional Comments:

Yes

No

None

___________________________________ ________________________ Name/Title of person completing questionnaire (dd/mmm/yyyy) Date

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