Site Assessment Questionnaire (Pre-visit)



Tool Summary Sheet

|Tool: |Site Assessment Questionnaire (Pre-visit) |

|Purpose: |To obtain information for assessment of site experience, capabilities, facilities, and overall preparedness for|

| |successful execution of study specific protocol requirements. |

|Audience/User: |CROMS, OCTOM, clinical site PI, clinical site study coordinator, NIDCR and program officials |

|Details: |This document serves as a guide for the collection of pertinent site information in the early stages of study |

| |start up. Information collected will inform CROMS/OCTOM in moving the site towards successful site activation. |

|Best Practice Recommendations:|This document may be used in conjunction with a teleconference at which the information is collected OR the |

| |questionnaire may be distributed for completion prior to the teleconference. It is at the discretion of the |

| |project leader to determine the best approach on a site by site basis. |

| |Known information will pre-filled to assist the site in completion. Additionally, questions that are not |

| |relevant will be eliminated (i.e., shaded grey) and will not be asked. |

| |Update the template to reflect study specific requirements ensuring that key points are captured (e.g., study |

| |supplies, staff experience, facility requirements, IRB). |

Tool Revision History:

|Version | |

|Number |Date |Summary of Revisions Made: |

|3.0 |29NOV2011 |Added Tool Summary Sheet and revised informed consent references |

| | | |

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. If a question is shaded grey, it is not applicable for your site and does not need to be answered.

[pic]

|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: |[pic] | N/A |

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: |

|Pharmacist: 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: |

|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: |

|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: |

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 team’s therapeutic specialty(ies)? | |

|Does the Principal Investigator have previous experience with: | N/A |

|Clinical Research? | |

|Study Therapeutic Area? | |

|Study Subject Population? |Yes Number of Studies:_____ No |

|Test Article/ Similar Product |Yes Number of Studies:_____ No |

|Similar Research Studies? |Yes Number of Studies:_____ No |

| |Yes Number of Studies:_____ No |

| |Yes Number of Studies:_____ No |

|Does the Study Coordinator have previous experience with: | N/A |

|Clinical Research? | |

|Study Therapeutic Area? | |

|Study Subject Population? |Yes Number of Studies:_____ No |

|Test Article/ Similar Product |Yes Number of Studies:_____ No |

|Similar Research Studies? |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 | N/A |

|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| N/A |

|population? | |

| |____ Total number “Open and Enrolling” |

| |____ Total number in “Follow-up Phase” |

|Does the PI and site personnel have sufficient time to: | |

|Conduct the study? | |

|Be available for monitoring visits? | |

|Attend study meetings? |Yes No |

| |Yes No |

| |Yes No |

|Will a licensed dentist or clinician be available on-site for study-related | Yes No |

|dental or medical decisions? | |

|Has the investigator(s) and/or site ever been inspected by a regulatory | Yes No |

|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

|Does the site intend to advertise for clinical study subjects? | Yes No |

|What languages are spoken in the target community from which subjects will be|Percentages of Population Represented: |

| | |

|Languages Spoken: | |

| | |

| | |

| | |

| |___% of Gen. Pop. |___% of Target Screening Pop. |

| | | |

| | |___% of Target Screening Pop. |

| |___% of Gen. Pop. | |

| | |___% of Target Screening Pop. |

| | | |

| |___% of Gen. Pop. | |

|Do the investigator and site personnel have adequate language capabilities | Yes No |

|for communication with the target community? | |

|Will consent documents, handouts, or advertisements be required in additional| Yes No |

|languages? | |

|If Yes, describe how the documents will be translated: | |

|Are there any foreseeable obstacles to enrollment, such as conflicts of | Yes No N/A |

|interest, site issues, or other enrolling studies? | |

|When will the site conduct study screening and other protocol required |Days/Hours of Visits: |

|visits? | |

|Can subjects reach site personnel at all times? |Yes No |

Protocol and Study Design

|Do you or any of your staff require additional training on the protocol or | Yes No N/A |

|study procedures in the following areas? | |

|If Yes, indicate areas: | |

|Study objectives? | Yes No |

|Inclusion/exclusion criteria? | Yes No |

|Study procedures including participant 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 |

|Investigator’s Responsibility for Protocol Conduct (delegation of tasks, | Yes No |

|participant safety, protocol compliance, participant confidentiality)? | |

Clinical Monitoring

|Will the study PI and staff be willing to allow a monitor (CRA) to come at least| Yes No |

|one time per year to ensure the protection of human rights (review of consent | |

|documents) and adherence to the protocol? | |

|Will the monitor have adequate workspace to conduct the visit? | Yes No |

|Will the monitor have access to the medical records (paper and electronic) so | Yes No |

|that adequate review of source documentation can be completed during the visit? | |

|Which source documents are usually kept in the participant’s medical record? | Consent document(s) |

| |Progress notes |

| |Medical history |

| |Clinical reports (e.g., lab, X-ray, ECG) |

| |Study specific worksheets |

| |Other, specify: |

Facilities and Equipment N/A

|Is there adequate examination/procedure room space to conduct assessments as | Yes No |

|specified in the protocol? | |

|Is there access to emergency equipment and facilities? | Yes No |

|Please describe the site emergency response plan: |

|Are the specific types of clinical equipment needed for this study available | Yes No N/A |

|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? | Yes No |

|Is there on-site access to the following equipment for both staff and CRAs: | |

|Telephone? | |

|Fax machine? | |

|Copier |Yes No |

|Computer with internet access for eCRF monitoring (if applicable) or internet|Yes No |

|availability? |Yes No |

| |Yes No |

|Will the CRA have adequate work space for monitoring activities? | Yes No |

|Does the site have adequate, secure storage for study records? | Yes No N/A |

|Where are the study source documents and are paper CRFs stored during study |Location of Source Documents: |

|conduct? | |

| |Location of Paper CRFs: |

|Are the source documents, including medical records, paper or electronic? | Paper Electronic |

|If electronic, will the CRA have access to them? | Yes No |

|If paper CRFs are being used, are they located off-site, outside the | Yes No N/A |

|site/clinic? | |

|If Yes, describe the frequency and method for transporting the data to the | |

|off-site location: | |

Laboratory N/A

|Will the CRA have access to the clinical laboratory facilities/equipment? | Yes No N/A |

|Are the specific types of clinical laboratory equipment needed for this | Yes No N/A |

|protocol available and maintained properly? | |

|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. Clinical site to clinical laboratory(ies)? |

|5b. Clinical site to research laboratory(ies)? |

|Is the trial site using a central/core laboratory? | Yes No N/A |

|If Yes, complete the following: | |

| |Name: |

|Name of central/core laboratory: | |

|Purpose of the laboratory? |Clinical safety Research specimen |

|IATA certification present for all site staff who will handle/ship hazardous | |

|materials |Yes No |

|Known difficulties/barriers with shipment from this site? | |

|Has this site previously worked with a central/core laboratory? |Yes No |

| | |

| |Yes No |

|Is the site using a local laboratory(ies) for clinical testing? | Yes No N/A |

|If Yes, complete the following: | |

| | |

|Name of local clinical lab for safety testing: | |

|Is the lab qualified/certified to perform procedures for the study? |Name: |

|Are the following available for review: | |

|Lab certification? |Yes No |

|Lab normal ranges? | |

| |Yes No N/A |

| |Yes No N/A |

|Is the trial site using a local laboratory(ies) for research specimen | Yes No N/A |

|preparation and storage? | |

|If Yes, complete the following: | |

|Name/location of local lab performing specimen preparation, storage, and/or |Name: |

|shipping: |Location: |

|List the storage equipment, security procedures, temperature monitoring | |

|procedures, backup power supply, etc.: |Storage, security, temperature monitoring, backup: |

|Contact person(s) for specimen preparation, storage, and/or shipping: | |

| |Contact person(s): |

|Is the trial site using a local laboratory(ies) for research specimen | Yes No N/A |

|analysis? | |

|If Yes, complete the following: | |

|Name/location of local lab performing on-site analysis: | |

|Protocol-related tests to be conducted by this facility: |Name: |

|Is staff available to perform protocol-related procedures? |Location: |

|Contact person(s) for research lab | |

|Are lab certification, reference values, and quality control procedures |Tests: |

|available for review? | |

|Are standard written policies and procedures for daily running/maintenance of|Yes No |

|lab equipment available? | |

|Describe the method to ensure refrigerator/freezer temperatures are |Contact person(s): |

|maintained within required ranges during normal work hours and procedures in | |

|the event of power outage or mechanical problem. |Yes No |

| | |

| |Yes No |

| | |

| |Description: |

|If your site is outside the United States, please answer the following | N/A |

|questions about clinical laboratory(ies): | |

|Does it have national or international certification? | |

|List the certification (if available) | |

|Does the lab perform quality control procedures and maintain copies of the |Yes No N/A |

|testing results? | |

|Does the lab maintain copies of the analyte reference value? |Certification: |

| | |

| |Yes No N/A |

| | |

| |Yes No N/A |

|Have protocol-specific lab requirements (specific collection/storage tubes, | Yes No N/A |

|labeling, storage temperatures, shipping schedule, etc.) been discussed with | |

|the laboratory(ies)? | |

Study Product/ Study Supplies N/A

|Is there adequate storage for test article in accordance with the protocol, | Yes No |

|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? | Pharmacy |

| |Nursing Station |

| |Clinic |

| |Off-site Facility |

| |Other, specify: |

|Describe security measures related to test article. |

|Do(es) the storage area(s) meet requirements such as temperature monitoring, | Yes No N/A |

|protection from light, and humidity? | |

|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 | Yes No |

|personnel and/or pharmacy personnel? | |

|Are the study personnel and/or pharmacy personnel familiar with test article | Yes No |

|accountability documentation? | |

|Who will administer the test article? |

Data Management N/A

|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 site’s research-specific electronic data management system 21 CFR Part| Yes No N/A UNK |

|11 compliant? | |

|Who at the site has the responsibility for: |

|Overall clinical data management (Name/Title): |

|On-site data analysis process (Name/Title): |

|Is there a site management group responsible for data review or analysis? | Yes No N/A |

|Is a Data Coordinating Center (DCC) used for this protocol? | Yes No N/A |

|If Yes, list the name | |

| | |

| |Name: |

|Are hospital/clinic records paper-based or electronic? | Paper-based Electronic Both |

|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 records will be available for CRA review? |Description: |

| | |

| | |

| | |

| |Clinic/hospital Research chart |

|If electronic information/data is used, describe general security and confidentiality measures. |

|Are clinic/hospital medical record storage facilities located near the trial | Yes No N/A |

|site? | |

|Which source documents are usually kept in the subject’s medical record? | Consent document(s) |

| |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. |

|Does the site have an SAE reporting system? | Yes No |

|If Yes, describe who is responsible for notifying the Independent Safety | |

|Monitor, IRB, Sponsor/NIDCR, and the chain of events. |Description: |

| | |

|Who has primary and secondary responsibility for reviewing and signing SAE | |

|reports? |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 | Yes No |

|off-site? | |

|If Yes, describe any special procedures for records review. | |

| |Description: |

Site Management N/A

|Who is responsible for the day-to-day management of the site? |

|Name/Title: |

|Does the site have a written Quality Management Plan (QMP)? | Yes No UNK |

|If Yes: | |

|Has the QMP plan been implemented? | |

|Was a copy provided to the NIDCR? | |

|Date QMP was written or last reviewed: |Yes No UNK |

|Who has responsibility for the day-to-day implementation of the QMP? |Yes No UNK |

|If No: |Date: |

|Does the site currently perform QM procedures? | |

|If Yes, describe the current QM process: |Name/Title: |

|Describe the communication methods available at this site. | |

| | |

| |Yes No UNK |

| | |

IRB/IEC and Regulatory Requirements N/A

|Who is responsible for maintenance of the site’s 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? |

|Are there any obstacles to timely IRB/IEC approval? | Yes No |

|If Yes, explain obstacles. | |

|Will submission to additional site committees (e.g. Research, Bio-Safety) be | Yes No |

|required? | |

|If Yes, list the names of the committees and any anticipated time | |

|constraints. |Name: |

|Do submissions need to be completed in a certain order? | |

|If Yes, provide the order: |Yes No |

|Does the site’s IRB/IEC have a Federalwide Assurance (FWA)? | Yes No |

Documentation of Policies and Procedures N/A

|Does the site have written SOPs/procedures for clinical research? | Yes No |

|If Yes, what SOPs does the site have? | |

|Does the site have a copy of the IRB/IEC policy concerning investigator | Yes No |

|obligations? | |

Training N/A

|Has the staff received training on ICH, GCP, and applicable regulatory | Yes No |

|training? | |

|Has the site staff completed the required Human Subjects Protection Training?| Yes No |

|Have key site personnel received training on NIDCR Investigator obligations | Yes No |

|for clinical research? | |

|If Yes, how were they trained? | |

|If Yes, when was the training completed? | |

| |Web-cast Investigator’s Meeting On-site |

| |training |

| | |

| |Training date: |

|Has the staff identified any additional training needs for site personnel? | Yes No |

|If Yes, list training needs: | |

|Are training records maintained for study staff, both general and study | Yes No |

|specific? | |

International Sites N/A

|Can the Principal Investigator and other site personnel communicate with the | Yes No |

|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? | |

|CRFs | |

|Source Documents | |

|Regulatory Documents |English Other: |

| |English Other: |

| |English Other: |

|Is the consent process conducted in English? | Yes No |

|If No, identify the language(s): | |

|Describe the site’s Informed Consent process: |

|Is there a written document, oral description, or other procedure? |

|Who will conduct the consent process? |

|Are all subjects literate? | Yes No |

|If No, identify the procedure for obtaining and documenting the Informed | |

|Consent process, including whether a short oral consent document is | |

|available: | |

|Are there local customs of which NIDCR should be made aware: | Yes No |

|If Yes, describe: | |

|Is there a community advisory board? | Yes No |

|Does the community leader, or village or tribal chief understand and support | Yes No |

|the study? | |

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

|Are there any country-specific requirements or potential difficulties that | Yes No |

|might interfere with regulatory approvals or subject enrollment? | |

|If Yes, please describe: | |

Conclusion

|Additional Comments: | None |

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_______________________________________ ________________________

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

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