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Do you provide your Satellite Site(s) with a dedicated inventory of Investigational Product?
Are you interested in conducting a COVID-19 related clinical trial
Do you have an SOP which supports calibration of the temperature monitoring equipment?
Does your Facility have computers which are dedicated to research studies?
Does the IRB/ERB/Ethics Committee require payment prior to release of final approval documents?
Patient Population Demographics
Academic / Phase IV trials
Is documentation kept on equipment calibration / control / maintenance / defects?
Can your Facility support patient visits on weekends?
If other provide details
Does the Facility have the required licenses or registrations to receive, store, dispense and return controlled substances as required by local law?
Does the Facility have the ability to handle radio-labelled Investigational Product?
Does your Facility have other review boards that need to approve the study prior to IRB/ERB/Ethics Committee submission?
Early bactericidal activity trial (Phase IIa trials: short term dose-ranging in patients)
Therapeutic area(s)
Is your Facility adequately staffed to support studies with both blinded and un-blinded Investigational Product?
TB Question 1
Do you have back-up power on site in case of outages?
What Electronic Data Capture (EDC) systems has your staff used for clinical trials?
If Other Line-Probe assays, please comment:
Are you able to store study medication at your clinical site? (requires restricted access)
If Other solid media, please comment:
Do you have the ability to recruit, consent and monitor participants remotely? If yes, please provide details
Do you have methods to identify MTB-complex from the positive cultures?
Do you have Affiliated Research Centre/Sites or Satellite Sites/Clinics?
IP recipient name
Site contact(s)
Check all equipment that will be available to Monitors
Does your Facility have a written SOP/Policy/Procedure to ensure that Investigational Product is appropriately maintained during transportation to Satellite Site(s)?
Do you have facilities to separate DS-TB subjects from the MDR-TB subjects?
If Yes, provide details about the role various committees play in your site's review and submission process. If you have multiple local IRBs, explain what drives the decision on which IRB to use.
Local IRB/ERB/Ethics Committee
How long is the anticipated turnaround time for sample results?
Does your Facility have secure storage for patient records?
Is your Facility affiliated with a government agency or part of a government funded health service?
How many COVID-19 participants could be enrolled per week?
Do you have access to the below Line-Probe assays (check all that apply)?
Minus 70 degrees Celsius freezers?
Study Type
Describe additional Investigational Product Storage & Handling Capabilities
Describe Other EDC Systems
Does your Facility have access to translators and translation support for study conduct
Minus 200 degrees Celsius freezer?
Specialties
Do you have a pharmacy located at your site?
Do you have isolation facilities for smear-positive TB?
Serial Sputum Culture Conversion Phase IIb trials (Proof of Concept for combination in patients)
Does your Facility have a written SOP/Policy/Procedure for: Minor Assent for pediatric populations?
For Facilities with satellite Centre/Sites, where is the monitor required to access source documents?
Please list any access limitations/requirements for the Electronic Medical Records
Do you have access to Phenotypic Drug Susceptibility Testing?
Please describe the country COVID-19 epidemiology?
Does the Investigational Product Storage Room provide Min/Max temperature monitoring?
In case of an emergency, do you have immediate/direct access to:
Do you have access to cultures on solid media listed below?
If interested what support do you need to help your team get started quicker?
Minus 800 degrees Celsius freezer?
What is the meeting frequency of your Local IRB/ERB/Ethics Committee?
Does the Investigational Product Storage Room have a temperature alarm?
If yes, indicate how many in space below
What study types does your Facility have experience with?
Does the Facility have storage space for Study-Related materials?
Please indicate if you have access to the following tests
Do you have the ability to generate a temperature monitoring log for this Investigational Product Storage Room?
Will your Facility require language translations for consents?
Does the Facility have access to local IT support?
Do you have access to the following:
Does your Facility use an external program to conduct research training?
Does the course content include GCP?
Please provide program course name
How long before IRB/ERB/Ethics Committee review is the Submission Packet required?
Do you have Electronic Health Records (EHR)/ Electronic Medical Records (EMR)?
Are there any other steps that the Sponsor should be aware of for your IRB/ERB/Ethics Committee review and submission?
Do you have staff (e.g. field workers) who would actively search for trial participants who missed their study visit?
Is an equipment maintenance schedule available?
Overview / description
Does your Facility have a written SOP/Policy/Procedure for: Informed Consent?
If a patient experiences an emergency, how long does it take to transfer your patient to the hospital?
Pediatric trials
Does your Facility have the ability to collect PK/PD samples beyond normal business hours?
If other provide details
If yes, indicate how many in space below
Department Contact Phone Number
Are processes in place to assure that “all” equipment (including back-up equipment) is periodically calibrated, controlled & maintained?
If other provide details
Minus 20 degrees Celsius freezers?
If other provide details
Does your Facility have the necessary equipment to treat medical emergencies
Do you have access to the below Acid Fast Bacilli (AFB) smears (Check all that apply):
Is your Facility capable of administering infusions?
Describe any additional equipment relevant to Clinical Trials
If Other liquid media, please comment:
From the time you receive the final protocol, taking into account Health Authority, Ethics Committee approval, contracting with the sponsor, any other approvals, how long (on average), does it take to start enrolment at your site? (Duration in months):
Is there isolated space that can be designated for COVID-19 therapeutic or vaccine trials including screening and follow up where appropriate?
Lab name
Does your Facility perform IRB/ERB/Ethics Committee submissions?
Patient Population Comments
Does the IRB/ERB/Ethics Committee require contract/budget approval prior to release of final approval documents?
Department Contact Email Address
Do you have an established Community Advisory Board (CAB) or Community Engagement Approach?
Does the site have continuous (24/7) temperature monitoring device for its freezers and fridges with an alarm that is calibrated, uniquely identified, allows for routine printouts of temperature logs?
If other GeneXpert, please comment
If other Acid Fast Bacilli (AFB) smear, please comment:
Laboratory technicians (for TB culture specimen processing):
Is your Facility able to initiate study activities prior to IRB/ERB/Ethics Committee protocol approval?
Do you have a process or program in place to retrain research staff when a protocol is amended?
Does your Facility have the ability to manage on-site or off-site destruction of Investigational Product?
Can your Facility support in-patient admissions for research studies?
Does your site have experience in clinical trials within the past 5 years?
Does your country have a national TB program?
Is there laboratory capacity to process and run COVID-19 swabs on site?
Do you have stable electricity on site?
Does your Facility have a dedicated department or group to perform IRB/ERB/Ethics Committee submissions?
Please explain how is your clinic trained to manage emergency events or anaphylaxis:
Do you have a relationship with a local hospital where patients can be hospitalized and remain in your care and continue participation in a trial?
Do you have access to any of the following consultants (Check all that apply):
Does your Facility have a training program for the research staff?
Does your Facility have the ability to manage on-site or off-site destruction of controlled substances when appropriate?
Does your institution and/or local regulation mandate the distribution of safety reports
Does the study staff that prepares or transports dangerous goods have training that meets the IATA International Air Transport Association (US) or other countries hazardous training requirements for shipping dangerous goods?
Identify the Diagnostic Equipment available at or near the Facility to support Research studies?
Department Contact Name
Does your study staff have sufficient English knowledge to understand communications in English?
Does your Facility have the ability to collect and store PK/PD specimens?
What type of source documents will be used?
Does your Facility have a written SOP/Policy/Procedure for destruction of Investigational Product?
Is all equipment uniquely identified?
If Other, please specify:
Is there a possibility to arrange medication delivery to study participants, where needed?
On average, how long would it take from start of screening of a participant to receiving intervention after recruitment into the study?
If yes provide Languages
Do you have access to the below listed GeneXpert?
Is your Facility using a local lab?
Does your Facility have patient record archiving on-site?
Does your Facility have a written SOP/Policy/Procedure for: Other vulnerable populations?
Lab contact
What type of computer operating system(s) does your institution use to support studies?
Does your Facility have an SOP or process that ensures routine calibration and maintenance of general equipment? Examples of general equipment include: scale, pulse oximeter, stadiometer, sphymomanomer, etc.?
Confirmatory Phase III Trials (Registration endpoint is a relapse-free cure)
What types of IRB/ERB/Ethics Committee does your Facility use? (Select all that apply.)
If patients are coming from outside your facility/practice, will you have access to their medical history?
What EMR/EHR system do you use?
Study phase capabilities
Field/social workers/Directly Observed Therapy (DOT) Coordinator(s):
Is there a plan for remote engagement with patients?
If located in the US, has your Facility used or are you able to use the informed consent short form?
Do you have access to cultures on liquid media listed below?
Refridgerator?
Is the Investigational Product Storage Room secured with controlled access?
Can the site collect any of the following samples (Check all that apply):
Does your Facility limit or prohibit access and use of external web-based tools or Centre/Sites for clinical research
Is the storage area for controlled substances securely constructed Yes with restricted access in accordance with local law?
Identify the Investigational Product preparation capabilities at your Facility
Local lab accreditation
Does your Facility typically allow the collection of Pharmacogenomic (PGX) samples for research purposes?
Can you dispense supply of investigational medicine for a research participant to take at home?
What type of internet access does your Facility have?
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