Click on STUDY/COUNTRY level.This is a view only screen!
To create a new Study/Country click on ADD in the lower right
toolbar in Selected
Studies/Countries and enter the data of the Study/Country Form.
To edit information on an existing study/country, highlight the
study/country and click on edit in the lower right toolbar in
Selected Studies/Countries and
edit the data of the Study/Country Form.
All studies/countries which you have selected in the
selection window are displayed here, i.e., as long as you
haven't entered a study/country and selected only your
current study in the selection window, this screen is empty.
If the screen is empty although you already created
study/countries, go back to the selection window and edit
your selection
This window is the Summary window of the Study/Country Form (3 tabs). It is a view only window. Editing information in the Selected Studies/Countries window itself is not possible
Selected Studies/Countries indicates the general characteristics of the currently highlighted study/country: Product, Country, Study No., Local Study Number, Short Study Title, Study ID, Coordinator (if applicable), Scientific Status, Target Number of Centers, Target Number of Patients.
Options linked to Selected Studies/Countries:This window is the Summary window of the Study/Country Form (3 tabs). It is a view only window. Editing information in the Selected Studies/Countries window itself is not possible
Selected Studies/Countries indicates the general characteristics of the currently highlighted study/country: Product, Country, Study No., Local Study Number, Short Study Title, Study ID, Coordinator (if applicable), Scientific Status, Target Number of Centers, Target Number of Patients.
PARAMETERS: to enter the
parameters of the study/country.
MANAGED COUNTRIES: to specify the
'Managed Countries' participating in a study.
ESSENTIAL
DOCUMENTS: to track the essential documents for
study/country level.
RECRUITMENT PLAN: to enter/edit
recruitment plan.
INTERNAL
PERSONNEL: to enter pre-selected correspondents, sponsor
and associated personnels, contacts for the study/country,
financial disclosure.
ASSOCIATED
PERSONNEL: to enter associated personnels and contacts for
the study/country.
PRE.SELECTED
COR. to enter pre-selected correspondents.
FINANCIAL DISCLOSURE: to enter
financial disclosure
REGULATORY AGREEMENT: to view
and/or enter information regarding center regulatory
approval.
MATERIAL: to
enter and track material used in the study (e.g., CRFs).
PROBLEMS: to
view and/or enter 'Problems' for a particular country
participating in a study.
SUMMARY:
to view and save summary of up to date patient statuses.
CENTRL. PROCEDURES: to track
centralized procedures such as lab.
EXTERNALIZED SERVICES: to
enter Organizations who are performing services for sponsor
with regard to the study/countr.y
FINANCIAL
CONTRACTS: to enter financial contracts of the
study/country.
DRUG KIT MANAGEMENT (Numbered,
Not
Numbered, Shipment,
Reception):
to manage drug kits for the study/country.
TRACKING: to
enter exchanges for the study/country.
FILES MANAGEMENT: to track the Trial master Files for
study/country level
EC/AUTHORITIES: to select the required EC/Authorities necessary
for the submission tracking for study/country level
SUBMISSIONS: to track all the submissions for study/country
level