Show:
CTMS-Site&Subject
Study Start-Up
Site
Essential Documents
eTMF
100
I need to put SIF information in this database
What is CTMS?
100
You ask me questions and document my answers on a form to determine if I can participate in your study?
What is Feasibility?
100
This form shows who at the site are given certain tasks to do during the trial and they have been trained on them?
What is a Delegation of Authority Log?
100
Investigator(s) will supply this essential document to subject(s) who freely give permission to participate in the clinical trial
What is the Informed Consent?
100
I need to update this to show how many documents are expected and how many are received
What is a Placeholder?
200
This person's role is "Safety Responsible"
What is the Principle Investigator?
200
All site information is recorded on this form to start entering me into CTMS at study start-up?
What is SIF (Site Information Form)?
200
Site must submit me before the trial starts. It shows whether specimens are in range?
What is Lab Ranges for tests/Normal Values?
200
To document competence of facility to perform required test(s) and support reliability of results.
What is a Lab Certification/accreditation for medical/lab/technical procedure tests?
200
I file the Protocol template in this location for CCO.
What is Country level?
300
I will be receiving SUSAR Safety Reports. Where would you add my role?
What is Safety Distribution Tab?
300
Identified, Feasibility, Pre-Study, Selected, Committed, Active, Follow-up, Prematurely terminated, Clinical Closure.
What is Site Status Flow?
300
What must a site have before they can be selected. This is the first point of contact when we call a site.
What is a Study Coordinator?
300
By having this granted by official or legal authority to perform medical acts and procedures and are not permitted by persons without one
What is a Medical License?
300
I am the cover sheet for Lab Normal Value
What is PD24?
400
I am the only document tracked in CTMS?
What is the approved ICF (Informed Consent Form) each version and all amendments?
400
I am entered in CTMS to track drug available at site, site activation date, clinical closure?
What are Milestone Dates?
400
We are not located where mostly subjects are seen who are participating in the clinical trial?
What is Satellite Sites?
400
To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects
What is a CV (Curriculum Vitae) aka resume!
400
I send this to CDC with an eTMF cover sheet to file instead of the TMF
What are forms with a wet signature?
500
You use me because my satellite site requires a separate drug shipment or study supplies that cannot be provided to the main site and dispatched to satellite facility?
What is Method 2?
500
The Country Operations Rep. must confirm that these documents are present and completion prior to the investigational site is activated and investigational medicinal product can be shipped to investigative sites
What is the Green Light Approval for Site Activation and Protocol Amendment Implementation - Inverventional Studies?
500
You need to send me to the site so that they know how to file and track files for the study
What is an eBinder?
500
To document that relevant and current scientific information about the investigational product has been provided to the investigator
What is the Investigator Brochure?(IB)
500
I am your guide on where to file documents in the eTMF
What is RRM Navigator?