Course Introduction
This course gives the student an introduction to Phase Forward a SaaS-based Integrated Clinical Research Suite which manages clinical development and safety processes from Phase 1 clinical trials through regulatory submission and post-approval monitoring. Phase Forward enables researchers, clinical development professionals, physicians, regulators and patients to more effectively and securely capture, contribute, access and share data.
You should have experience with all of the following:
· Medical industry concepts and terminology.
· Clinical trials processes and procedures.
· Using a personal computer and a mouse.
· Microsoft Windows operating system.
· Microsoft Internet Explorer.
· Microsoft Excel.
This course is intended for clinical trial professionals who are
responsible for reviewing electronic clinical data. This includes:
· Clinical Data Managers (CDM).
· Principal Investigators (PI).
· Other sponsors and CRO staff.
After completing this course, you should be able to
Log on to an InForm trial and manage a user profile.
Review clinical data in an InForm trial.
Lesson 1 An Overview of InForm Software 1
Objectives...........................................................................................................................1
Examining a typical InForm trial environment .........................................................................2
Examining InForm trials ...................................................................................................2
Introducing InForm trial concepts and terminology ..................................................................3
Examining site user activities ...........................................................................................3
Examining sponsor user activities ....................................................................................4
Examining the user activation process .......................................................................................5
Examining InForm trial security features........................................................................5
What if I forget my password ............................................................................................6
Lesson 2 Getting Around in an InForm Trial 7
Objectives...........................................................................................................................7
Examining InForm trial navigation features .............................................................................8
Examining the navigation features on the Case Books for Site page.............................9
Examining visit and form navigation features...............................................................10
Examining the navigation features on the home page ..................................................12
Lesson 3 Preparing an InForm Trial for Review 13
Objectives.........................................................................................................................13
Examining source verification activities...................................................................................14
Examining the signature status in a trial ......................................................................14
Examining how investigators sign eCRFs and CRBs ..............................................................16
Examining where a trial requires signatures.................................................................16
How do investigators sign eCRFs and CRBs..................................................................16
Examining signature tools for investigators ..................................................................16
Lesson 4 Performing End-Of-Trial Activities 19
Objectives.........................................................................................................................19
Examining sponsor end-of-trial activities .................................................................................20
Locking eCRFs and CRBs................................................................................................20
Signing eCRFs and CRBs ................................................................................................21
Producing data export listings.........................................................................................22
Examining the InForm trial locking features...........................................................................23
Examining the Lock eCRF feature..................................................................................23
Examining the lock visit feature .....................................................................................24
Examining the lock CRB feature.....................................................................................24
Examining the Listings Export Tool .........................................................................................25
Phase Forward Systems Support Analyst