Site Evaluation
Site Activation
Site Monitoring
Site Closeout
Potpourri
100
What type of responses require comments to be entered when completing a site evaluation visit report checklist?
A "no" response requires a comment.
100
When should you input Site Milestone dates into the Activity Plans tab?
As soon as possible during the Activation process.
100
Your draft report has been written, where do you indicate the report has been completed?
In Trip Report details view, enter date in "Trip Report completed" field. NOTE: This is a different place than the "Visit Completed" field.
100
True or False: Planned LPLV date in the Milestone Activities tab must be updated if original target date changes.
True- you must update planned start dates to Milestone activities asap once changes are known.
100
How do you add contacts as attendees in your report?
*In report view, click on "Attendees" field *Click on the personnel that were present and click "add" *To add Alcon personnel, click "All Contacts" and query for yourself and any other Alcon personnel that were present during the visit. Click on their name and click "add"
200
What 2 templates must be added to the Activity Plans tab at the beginning of a study (at site level)
1. Standard Protocol Milestone Activities/Site 2. Monitoring Visit Plan
200
True or False: After you click on the "Submit" button, a trip report becomes read-only.
True. If you notice that something is incorrect on your report after you have already submitted it, you can immediately put the report back to "in-progress" and correct your mistake, and re-submit.
200
Demonstrate how to verify if subjects have been enrolled at a given site.
In the main site view, select the "Subjects" view tab on the lower level and subjects should be listed here. *Also can run a query with "is not null" in the enrollment ID field.
200
What additional section needs to be completed in a site close-out visit report checklist?
Section E- Close-out activities
200
What must be done to ensure that the contacts at your site are available to be added to the Attendees list in your report? and how do you accomplish this?
The contact MUST be "affiliated" with that particular site (for that particular protocol) *Ensure the person is listed in the main Contacts tab, if not add the person and wait for CTMS admin to approve the addition *Query for your protocol specific site under the Site Management tab *Drill into the Contacts view tab on the lower level of the Site view *Click "new" add the Role of the person to be added *Under the last name field, click on the little box and search for your contact *Click add
300
Where can you look to find out if a CDA has been executed for a particular site?
*Under the main "Accounts" tab, query for your Account. *Click on the lower view tab "Agreements" *The CSA and CDA will be listed here. NOTE: CDA is not called "CDA". It will be called "Pharmaceutical Ocular Related Disorders" or "Surgical Ocular Related Disorders"
300
Your Site Initiation Visit report has been approved. How do you enter the initiated date for the site?
In the site form, enter the appropriate date in the "Site Initiated" field.
300
How do you apply a "Site Monitoring-Interim" report template to a site?
*Site Visits view tab *Click on Visit Start hyperlink *Select the 'Site Monitoring Report CS020A' in the Template field
300
How do you change a site status to "Closed"
*In site details view change Status field in form to "Closed" *Select appropriate date in the Site Closed field
300
Demonstrate how to add your Lead CSM or Manager to your CTMS calendar.
*Under the CTMS calendar tab: -Select "Access List" and click "New" button -Query for your LCSM or RM and click "OK"
400
Demonstrate how to apply a Monitoring Visit plan template to a site.
*Click on the Activity Plans view tab in the appropriate Site *Click the New button *Select Monitoring Visit Plan Template
400
What do you need to do to be able to update a returned Site Initiation Visit report?
Select "In progress" in the trip report's Status field.
400
Demonstrate how to create an additional Interim Site Monitoring report.
*Site Visit view tab *Click the "New" button *Select the "Site Monitoring-Interim" report from the list *Rename the report and add visit date, visit method, and "scheduled" to the report
400
Demonstrate how to reorder the columns of a returned report checklist in the following order: *Reviewer comments *Instructions *Response *Answer *Comments *Follow-up
Good for you!
400
Demonstrate how to reorder the Main Tabs that you see when your CTMS first opens.
*Click on the Site Map (Globe icon) in the upper left part of your screen *Click on "User Preferences" tab *Click on the "Tab Layout" *Use the check marks to hide or un-hide tabs you want to see in your layout *You will have to log out of CTMS and log back in for this change to take effect.
500
Demonstrate how to apply a Site Evaluation Report template to a Site.
*Site Visit view tab *On the Site Evaluation record -Update name "C11034 SEV JPeveto" -Update Visit Status field (scheduled) -Update Visit Date field with planned SEV date -Update Visit Method field (on-site or telephone) *Drill into the Visit Start Date hyperlink *Select Site Evaluation Report in the Template field pull down menu (always choose CS004 Revised, not CS004a)
500
Demonstrate how to print the Site Initiation Report.
*Scroll down in the Site Initiation report view *Click on the "Alcon Reports Selection" view tab *Select appropriate report *Click "Run" *Close the blank window (only in training database) *Click "Run" again *Print report
500
Demonstrate how to route a Site Interim Report for content review and approval.
*Ensure you're the Primary owner in the Owned By field *Click the Select button in the Assigned to Last Name field *Find and select your manager as appropriate reviewer *Click the Submit button
500
Demonstrate how to access a returned Site Close-out Report
*Query for your Site in "Site Management" tab *Click on "Site Visits" view tab *Click on the Visit date for the returned report *Change the Report Status back to "In-Progress" *Check the report for Reviewer Comments and correct items and re-submit to Reviewer
500
Site A wants to add a Satellite site with the same name as their main site. Demonstrate how to add this new location to their Account.
*Query for Site A under the main Accounts tab *Drill down into the lower "Addresses" tab *Click "New" *Enter site's new address. If this will be the primary address, you can change the "primary" check to this address. NOTE: this method only works if both locations have the same name, i.e. "City Eye Clinic". If the two locations have different names, you will have to set up a new account for the satellite site with the different name.
M
e
n
u