Is a study synopsis or protocol available? Yes - Provide Later Yes - NDA Required No
NDA contact email *
Business name *
NDA instructions or comments
What are the primary objectives of the study? Objectives are not yet finalized Obectives are finalized - specify below Unsure - dicentra to advise
Please specify the primary objectives below
What is the study phase or category? Not yet determined Phase 0 - Exploratory/Observational or First-in-Human Study Phase I - Initial Safety Evaluations Phase II - Explore Efficacy While Maintaining Safety Phase III - Final Confirmation of Safety and Efficacy Phase IV - Study Conducted After Market Approval Not applicable - behavioural, usability, observational, or no investigational product Unsure - dicentra to advice
Describe the intended study population Population is not yet finalized Population details finalized - specify below Unsure - dicentra to advise
Has the target sample size been determined? No-not yet determined Yes A preliminary estimate is available Unsure - dicentra to advise
Please specify the target sample size
Please provide preliminary estimate
Is sample-size calculation or justification support needed? Yes No Not yet determined Unsure - dicentra to advise
What is the target indication, intended purpose, or planned use? Not yet finalized Describe target indication below Unsure - dicentra to advise
Please describe the target indication, intended purpose, or planned use below:
Describe the study design
Study procedures Not yet determined Describe procedures below Procedures are still being developed Unsure - dicentra to advise
Briefly describe the procedures participants will undergo
Is the number of Canadian sites known? Not yet determined Yes Preliminary estimate Unsure - dicentra to advise
Number of planned Canadian sites 0 (sites don't apply) 1 2 3-5 6+ decentralized
Are the Canadian provinces or territories known? Not yet determined Yes Partially Unsure
Are the Canadian sites identified? Not yet determined All sites are identified Some sites are identified Unsure - dicentra to advise
Is the number of U.S. sites known? Not yet determined Yes Preliminary estimate Unsure - dicentra to advise
Number of planned U.S. sites 0 (sites don't apply) 1 2 3-5 6+ decentralized
Are the U.S. states known? Not yet determined Yes Partially Unsure
Are the U.S. sites identified? Not yet determined All sites are identified Some sites are identified Unsure - dicentra to advise
Is the number of EU/EEA sites known? Not yet determined Yes Preliminary estimate Unsure - dicentra to advise
Number of planned EU/EEA sites 0 (sites don't apply) 1 2 3-5 6+ decentralized
Are the countries or Member States known? Not yet determined Yes Partially Unsure
Are the EU/EEA sites identified? Not yet determined All sites are identified Some sites are identified Unsure - dicentra to advise
Describe the product, device, intervention, procedure, test, or technology being studied
What type of medical device is involved In-vitro Diagnostic Device Non-IVD Medical Device Both Not yet determined Unsure - dicentra to advise
Is the regulatory classification of the device known? No - not yet classified Yes Partially - known in some jurisdictions Unsure - dicentra to advise
Canadian device class Class I Class II Class III Class IV
US device classification Class I Class II Class III
EU device class Class I Class II Class III
Product, device, or intervention name
Manufacturer
Is the product currently marketed in any jurisdiction? No Yes Marketing application in progress Unsure - dicentra to advise
Is a placebo, comparator, control product, or reference method involved? Yes No Not yet determined Unsure - dicentra to advise
Describe the comparator or control
Additional product comments
Has the requirement for a Health Canada Investigational Testing Authorization been determined? Yes - an ITA is requried Yes - an ITA is not required An ITA has already been submitted An ITA has already been authorized Assessment is underway Not yet determined Unsure - dicentra to advise
Current ITA status Not started Strategy/planning Documents in preparation Under internal review Submitted Questions received from Health Canada Authorized Not applicable Unsure - dicentra to advise
ITA Responsibility dicentra Shared responsibilty Sponsor To be determined
Has the requirement for a Clinical Trial Authorization application been determined? Yes - an application is required Yes - an application is not required An application has already been submitted Authorization has already been received Assessment is underway Not yet determined Unsure - dicentra to advise
What type of CTA is needed? Natural Health Product clinical-trial authorization Pharmaceutical Clinical Trial Application Biologic Clinical Trial Application More than one pathway may apply Not yet determined Unsure - dicentra to advise
Current status of application Not started Strategy/planning Documents in preparation Under internal review Submitted Questions received Authorized Not applicable Unsure - dicentra to advise
CTA Responsibility dicentra Shared responsibilty Sponsor To be determined
Has the need for Research Ethics Board been assessed? Yes - REB approval is required Yes - REB is not required Assessment is underway Not yet determined Unsure - dicentra to advise
Has IND applicability been determined Yes - an IND is required Yes - an IND is not required An IND has already been submitted An IND is already active Assessment is underway Not yet determined Unsure - dicentra to advise
Current IND status Not started Strategy/planning Documents in preparation Under internal review Submitted Questions received from Health Canada Authorized Not applicable Unsure - dicentra to advise
IND responsibility dicentra Shared responsibility Sponsor Not yet determined
Has the U.S. device-study risk determination been completed? Yes - Significant risk Yes - Nonsignificant risk Yes - Exempt Assessment is underway Not yet determined Unsure - dicentra to advise
Has IDE applicability been determined? Yes - an IDE application is required Yes - the abbreviated IDE pathway applies Yes - the study is IDE exempt An IDE has already been submitted An IDE has already been approved Assessment is underway Not yet determined Unsure - dicentra to advise
Current IDE status Not started Strategy/planning Documents in preparation Under internal review Submitted FDA questions received Approved Abbreviated IDE/IRB pathway Exempt Unsure - dicentra to advise
IDE responsibility dicentra Shared responsibility Sponsor To be determined
Has the need for ethics approval been assessed? Yes - IRB approval is requried Yes - IRB approval is not required Assessment is underway Not yet determined Unsure - dicentra to advise
Has the applicable EU medicinal product clinical trial route been determined? Yes - a clinical trial application is required Yes - no clinical trial application is required Submission is underway Authorization has been received Assessment is underway Not yet determined Unsure - dicentra to advise
What is the status of the clinical trial application Not started Strategy/planning Documents in preparation Under internal review Submitted Questions received Authorized Not applicable Unsure - dicentra to advise
Clinical trial application responsibility dicentra Shared responsibility Sponsor To be determined
Has the applicable medical device clinical investigation route been determined? Yes - an application is required Yes - an application is not required Submission is underway Approval/authorization has been received Assessment is underway Not yet determined Unsure - dicentra to advise
What is the status of the application Not started Strategy/planning Documents in preparation Under internal review Submitted Questions received Authorized Not applicable Unsure - dicentra to advise
Application responsibility dicentra Shared responsibility Sponsor To be determined
Has the applicable IVD performance study route been determined? Yes - a performance study application is required Yes - an application is not required Submission is underway Approval/authorization has been received Assessment is underway Not yet determined Unsure - dicentra to advise
What is the status of the application Not started Strategy/planning Documents in preparation Under internal review Submitted Questions received Authorized Not applicable Unsure - dicentra to advise
Application responsibility dicentra Shared responsibility Sponsor To be determined
Has the need for REB approval been assessed? Yes - REB approval is required Yes - REB approval is not required Assessment is underway Not yet determined Unsure - dicentra to advise
Does the study involve human participants, identifiable human data, or human specimens? Yes No Not yet determined Unsure - dicentra to advise
What is the current ethics-approval status? Submission is not started Submission is underway Approval is needed Approval has already been obtained Ethics review has been determined to not apply Applicability assessment is underway Unsure - dicentra to advise
Approving board name
If other please specify
Sites covered by approval
Are amendments or continuing reviews expected? Yes No Not yet determined Unsure
Does dicentra need to manage ongoing ethics activities? Yes No Shared responsibility Unsure - dicentra to advise
Questions, comments, or issues regarding the ethics approval status?
Board name
Who is responsible for the active submission dicentra Site Shared responsibility Sponsor To be determined
Questions, comments, or issues regarding the current ethics submission?
Who should be responsible for the ethics submission? dicentra Site Shared responsibility Sponsor To be determined
Is a central board expected? Yes No Not yet determined Unsure
Are local or site-specific boards expected? Yes No Not yet determined Unsure
Are any sites academic or hospital-based? Yes No Not yet determined Unsure
Are translations expected? Yes No Not yet determined Unsure
Is continuing review expected? Yes No Not yet determined Unsure
Questions, comments, or issues regarding the upcoming ethics submission?
Who made the determination? Sponsor Ethics board Regulatory authority Another party Unsure
Please provide the rationale
Do you require assistance with your Study Protocol Yes No Unsure
Do you have an Investigators Brochure/Instructions for Use? No Yes A draft exists Unsure
Have Informed Consent Forms been prepared? No Yes A draft exists Unsure
Have Case Report Forms been developed? No Yes A draft exists Unsure
Have participant recruitment materials been developed? No Yes A draft exists Unsure
Has a Trial Master File been established? No Yes A draft exists Unsure
Have product or device labels been prepared for the study? No Yes A draft exists Unsure
Has a Statistical Analysis Plan already been prepared? No Yes A draft exists Unsure
Questions, comments, or issues regarding Essential Documents?
How would you like dicentra to support the management of your study? dicentra will serve as the primary CRO and manage the study dicentra will manage selected portions of the study Our team will manage the study internally We're not sure yet
Questions, comments, or issues regarding Project Management?
Questions, comments, or issues regarding Quality Management?
Questions, comments, or issues regarding Site Managment?
Questions, comments, or issues regarding Monitoring?
Questions, comments, or issues regarding Participant Recruitment?
Which EDC Platform are you using?
Anything else you'd like dicentra to know about your data management requirements?
Is there anything else you'd like dicentra to know about your statistical requirements?
Is there anything else you'd like dicentra to know about your medical writing or publication requirements?
Is there any other services you'd like dicentra to provide that hasn't already been captured?
When would you like the study to begin? As soon as possible Within the next 3 months WIthin the next 6 months from now More than 6 months from now Timeline not yet determined
Approximately how long do you expect the study to run Less than 3 months 3-6 months 6-12 months 12-24 months More than 24 months Not yet determined
Has a budget been established for this project Yes Preliminary Budget Not Yet Prefer to Discuss
Additional Timeline or Budget Comments?
Additional pass-through cost comments
Is there anything you'd like us to know about your previous CRO experience?
Is there anything else you'd like dicentra to know about your study or proposal requirements?
