InForm4.6 Module E Enrolling a Patient V1.0 27Feb2013.ppt

Enrolling a patient in InForm 4.6 Course version 1.0 [27 February 2013]

Notes:This course will show you how to enter data in InForm version 4.6

The course is suitable for CTC or external staff in the following roles:

Clinical Trials Assistant

Data Manager

Site Data Manager/Study Nurse

Trial Coordinator

Project ManagerProject Manager

Prerequisites

Basic knowledge of Clinical Trials and Randomisation processes.

Competence in using web based software applications.

Completion of course: Introduction to InForm for CTC studies

Completion of course: Data Entry in InForm

© NHMRC Clinical Trials Centre, 2013 1


Notes:This course is divided into sections as listed above



Notes:



Notes:Most CTC InForm studies enrol patients using the ‘Enroll’ function in InForm.

However, some CTC studies may use an IVRS (phone-based voice recognition system) or other enrolment method, in which case this step will be skipped and you should refer to the Study Manual for study-specific enrolment instructions.

For the purpose of this training, we will enrol patients via the InForm ‘Enroll’ function.



Notes:To start screening a patient, click on the ‘Enroll’ button in the navigation bar at the left of the screen.



Notes:You will see the Screening Log page.

If you have access to more than one site in the training database, a dropdown list will appear at the top right corner of the screen. Choose the relevant site.

It is very important that the correct site is chosen before proceeding, as this mistake cannot be rectified once ‘Add Candidate’ has been clicked.

If you have access to only one site in the database, the site name would be displayed in the top right corner of the screen instead of a dropdown list, and the ‘select site’ step can be skipped.



Notes:Enter data for all items on the screening CRF, check your data, then submit.

A temporary Patient Screening Number will be assigned, and the screen will return to the Screening Log.



Notes:To address each query, click on the patient’s screening number in the first column, which will take you back to th ithe previous screen.

All screening failure comments must be addressed before you can progress with the enrolment.

Tip: Because Screening Failure queries are not displayed on the Screening CRF itself, make a note of the query(s) before clicking on the Patients screening number.



Notes:On the Screening CRF, check any item(s) that have caused Screening Failures:

•If due to a data entry error, revise the item(s)

•If data is correctly entered, but has caused a Screening Failure, the patient may be ineligible. Contact the CTC. Do not proceed with the enrolment until advise has been obtained from the CTC.

Once all issues have been resolved (or to check if any issues remain unresolved), click Submit on the Screening CRF. This will re-check the Screening CRF.

You can ‘Re-Submit’ the revised Screening CRF as many times as necessary to resolve all issues – there is no limit.



Notes:



Notes:Enter the name of the Investigator who has confirmed the eligibility of the patient according to the study protocol.

This Authorising Investigator must be listed on the Site Signature Log for the study.



Notes:Click the [Enroll] button to proceed.

Note that if you click [Do Not Enroll] instead, the patient will not be enrolled and you will return to the Screening Log screen.



Notes:The Enrolment screen displays an indicative schedule of visit dates for this patient, based on the Date field h t th t f thshown at the top of the screen.

If your study has fixed visit intervals this may be of some use, but if the visits are triggered dynamically no dates will be shown.

The date does not actually schedule the first or subsequent visit(s), it is used for display purposes only.

Click [Go To First Visit] to complete the enrolment.



Notes:All items on this eCRF will be blank until date is submitted.

*Depending on how patient numbers are assigned for the study:

In some cases, the patients permanent study number will appear with the patient initials at the top right of the screen, and data entry in all other eCRFs can proceed.

In other cases, a temporary number will be displayed (starting with ENR), and the permanent study number will , p y p y ( g ), p ynot be assigned until a later stage, e.g. after randomisation.



Notes:If any queries are visible, or any data is incorrect, do not proceed. Instead, please contact the CTC.



Notes:If your study is non-randomised (i.e. registration only), this stage will be skipped.

Before commencing this stage, all Enrollment stages must be completed, including checking that all data on the Screen & Enrol Details CRF is complete, correct and no queries exist.

If any queries are visible, or any data is incorrect, do not proceed. Instead, please contact the CTC.



Notes:See Module A: Introduction to InForm for instructions to print a CRF



Notes:


InForm4.6 Module E Enrolling a Patient V1.0 27Feb2013.ppt

Documents

Transcript of InForm4.6 Module E Enrolling a Patient V1.0 27Feb2013.ppt