Before learning RDC Onsite, you must understand the basic structure or elements of RDC Onsite. When you login to RDC Onsite, you will automatically redirect to Home page then you can see some links and options which helps you to operate RDC system. Each and every element contain sub-items or sub-menu.

Now when you enter your login username and password then you will automatically redirect to RDC Onsite home page and it is something like this. See below image:

OC RDC Home Page

We know that RDC Onsite is web application or just like a website. So every page of RDC Onsite consist three part: Top page header section, Middle Work Space and Page footer section.

1. Page header section located at the top of every page. It provide information about current session and Global links for logging out, password change and getting help. Header options always available and do not change when you navigate from page to page.

2. The center part of page is called work space where you perform your daily tasks and activities. It contain tabs to navigate other pages and tools which helps you to view, enter and update patient data. Content of the work space varies depending on the page.

3. The page footer is same as top header section. It contain About RDC link, page navigation links (same as page tabs) and all global links found in header section. Again footer options always available and do not change when you navigate from page to page.

Home Page or Page Tab Options

You can see the Page tab in above image. Page Tab have main tabs items and other sub-menu items.

Page-tab

1. Home Page

Home Page is nothing else it is just a main page displays after log in. Home page is the starting point for all tasks or activities. In home page you can see all the patient related activities, current sites and studies. You can select one or more patients and then select an action to perform, such as the patient casebooks. You can directly search a specific patient with the help of patient ID, view patient summary report and check news updates from sponsor.

2. Casebooks Page

Another tab is Casebooks, here you can view the patient data and CRFs with spreadsheet and grid pattern. It is a unique page in RDC onsite for several reasons:

  • It is used for data entry work for a CRF
  • Casebooks show the complete status of CRFs, like expected, and entered CRFs which is displays in spreadsheet format. On the other hand other pages show information in a list format.

3. Review Page

Review pages have some other sub menu items through which you can check CRFs, discrepancies, investigator comments and special listings.

  • In CRFs sections you can review CRFs for verification and approval
  • In Discrepancies link, you can view, correct and manage discrepancies to ensure that data is complete, accurate and compliant as per study protocol.
  • In Investigator Comment sections, you can view, add and update investigator comments to a response in the CRF.
  • In last Special listings section, you can see additional information like adverse events (AEs) and concomitant medications (ConMeds).

Note: Review Special Listings is only work with the combination of Thesaurus Management System (TMS). So first check TMS is properly installed or integrated with Oracle Clinical Database.

4. Reports Page

In Reports page you can view, generate and print patient data reports. You can monitor in-process reports and search specific reports.

Session Information in RDC Onsite

RDC Onsite header section have a specific feature, it displays information about your session of every page. Session is the time period of your operation in RDC Onsite. It records your all login and logout details and time. It displays following details in particular format:

Logged in as username (role, database); Last Refresh dd-mmm-yyyy hh:mm:ss

See below Image:

session

In above Image you can see, session information displays, username which is given by sponsor. User Role is main factor here which give you the permission and authorities to access and modify data. As per user role you can perform specific task you can complete and grant you specific privileges. See user role and permissions

Next is database name, It is again very important factor in RDC Onsite. All study related data and modification are saved in selected database. Last one last refresh date and time, here you can see your last refresh time and on the basis of this you can prevent your session from session timeout issue. By default, RDC Onsite timeout is 30 minutes after inactivity. But you sponsor can change this timeout limit.

If you are inactive for this specified period of time then RDC Onsite will automatically times out and redirect to log in screen.

 Caution: Unsaved work is lost when a session times out. To avoid losing your work when RDC Onsite times out, check the timeout period for your study, and routinely save your work. As per RDC Onsite documents and it is for security purpose of unauthorized use of RDC Onsite.

Global Links in RDC Onsite

You can see Global Links in header and footer section of RDC Onsite. It contain logout, Preferences, Change password and Help links.

1. Logout: It appears when you log in to RDC Onsite home page. It is not present in Login screen because you are not logged in.

2. Preferences: Here you can change the view of page and items per pages, Format of dates and select you local time zones.

3. Change password: Already discussed in my previous post

4. Help: Open and search online helps

Note: Global Links may be different from default links. Sponsor can customize RDC Onsite as follow:

  • Preference Link unavailable
  • Rename change password link
  • Add link that displays information of your site, sponsor or CRO. By default it is Contact Us and sponsor can rename this link.