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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