Frequently Asked Questions
This is a list of questions and clarifications which will be updated periodically
- The E-CRF appears slow to update. Why is this?
- Can I/Do I have to change my password?
- How do I use the "Page Intentionally Blank" and "Ready to Trasmit" Boxes?
- How do I enter dates and times?
- How do I add an extra CRF page for ConMeds, Medical History etc?
- How do I enter multiple criteria in a CRF field?
- What do the terms "Registering" and "Enrolling" a subject mean?
- How do the CRF signature fields work?
- NEW: How do I scan Source Documents?
Q: The E-CRF appears
slow to update. (First Time use of the EDC System)
A: After opening a study or creating a new subject CRF the EDC system may appear to take some time to start (10-20 seconds,
depending on the speed of the internet connection). This is because an amount of metadata must be loaded from the study database -
however these will be cached on the local computer so that subsequent starts will be much faster.
The system will always check to make sure that the cached data are
current with respect to the data on the study server - if the local
copy is out of date, it will be reloaded (which will also incur a
delay)
The status bar at the bottom of the EDC screen provides information about what the application is currently doing.
Q: Can I change my password?
A: Your password is set by Data Management - you do not need to, and cannot, change this
yourself. Passwords are required to be a mix of upper and lowercase letters and numerals.
Your password is composed as follows: The first letter of your first name in Uppercase, followed by
the first and second letters of your surname in lowercase, followed by a 4-digit "pin" number.
Q: Use of the “Page Intentionally Blank” and “Page Ready for Transmission” check boxes.
A: Each E-CRF page contains these boxes in the page header.
- If a page intentionally contains no data whatsoever (even “not done” boxes), but should nonetheless be submitted to data management for the sake of completeness, then
the "Page is Intentionally Blank" box should be checked. It will override any edit checks on the page,
although note that there may be data in the page header, such as the
page date, which does need to be completed. If the body of
the CRF page does contain any sort of data, a warning will be issued.
- When a page has been filled in with data (or marked intentionally blank) and all edit checks are satisfied then the "Page is Ready for Transmission" box should be checked. Only then will the page be considered for submission to the online database. The primary purpose of this is to prevent unintended submissions.
Q: Date and Time formats
A: The date format used is consistently DDMMMYYYY (e.g. 25DEC2010)
throughout the EP-ILC-201 CRF. Times should be entered on a 24-hour clock as four digits (e.g. 0830, 1545 etc).
Times which occur at midnight should be entered as “0000” and any associated date adjusted as necessary.
The time “2400” is not valid.
If you need to enter a partial date, use two hyphens ('--') for the missing part(s). For instance, to indicate a date sometime in year 2008, enter '----2008'. To indicate a date in February 2005, enter '--FEB2005'
A: Some CRF pages are designated as “repeating pages” – these are all pages where there is potentially more data to be entered than will fit on a single page. Examples are Medical History, Concomitant Medications etc. The CRF automatically includes one copy of each such page – if extra copies of such pages are required then the E-CRF screen includes a “Repeat Page” button (beneath the E-CRF table of contents) which will create a new page copy. Page numbering occurs automatically.
(Note: there are also “Repeat Section” and “Optional Section” buttons, but for EP-ILC-201 these will not be required)
Q: Multiple Criteria
A: If a data field calls for multiple criteria to be entered (for instance “Enter the Inclusion Criteria which were not met”), then the items should be entered as a blank-
or comma-separated list.
Q: "Registering" and
"Enrolling" subjects
A: The TrialDriver EDC system uses the terms "Registering" and
"Enrolling" subjects in the following ways:
When you have a new subject for whom an E-CRF is required, you first choose an entry in your subjects list which is marked "NOT REGISTERED". Double clicking this entry will open a dialog in which you enter the subject's initials. Therafter the subject is considered "registered" and the subject status becomes "SCREENING". An E-CRF will be created, which at this point contains only the screening sections of the CRF.
If after Screening the subject is considered eligible to participate in the treatment part of the study, that subject will need to be "enrolled". To do so, select the entry in your subjects list and click the link (beneath the subjects list) labelled "Enroll this subject". You will be asked for confirmation that the subject meets all required entrance criteria. Thereafter the main sections of the CRF will be added to the subject's E-CRF
Note: The E-CRF screening sections also contain questions as to the eligibility of the subject. These questions must all be answered "YES" before the system will allow the subject to be enrolled.
Q: CRF Signature Fields
A: The VTI-208 CRF contains checkbox fields on some pages which
indicate an investigator signature and which represent a sign-off of
all or part of the E-CRF. Signature fields can apply to the whole
CRF, a single visit or a single page. Whenever such a signature
field is checked, the pages of the CRF to which it applies are
locked to prevent further changes.
To apply a signature, the applicable part of the CRF must be completely error-free and ready for submission. This includes placing a check mark in the "Page is ready for Transmission" box, which counts as an error if it is not checked. Any page which displays a yellow icon in the CRF table of contents is ready for transmission. The signature box on the End of Study page of the VTI-208 CRF locks the entire CRF, and therefore all pages in the CRF must be ready for transmission (or already have been submitted) before a signature in this field is accepted.
If changes have to be made to the CRF, the signature field can easily be unchecked, which will unlock the applicable pages. Not all users have the right to apply or remove signatures to the CRF - this is a special permission in the user profile and must be configured by study management.
Q: How do I scan source documents (Best Practices)
» For each subject, the TrialDriver EDC system contains the following tabs:- View Queries
- View Source Docs (Source Documents)
- Scan Documents
Select “Scan Documents” to begin scanning
If the source document visit is > 15 pages, scan the 1st 15 pages and continue to scan the additional pages until the entire visit is “complete” before selecting “Cancel and Upload”. This will generate 1 complete scanned document.
» The best scanner setting = Black & White at 200 dpi. This is the fastest scanning speed.
» PLEASE ENSURE that you have selected the correct subject in the EDC BEFORE you scan the documents to the subject’s file.
» The scanned Source Documents will be managed by the CRA and moved to 1 of 3 folders within TrialDriver for LT storage:
a. Open = CRA currently working on SDV
b. Closed = CRA has completed SDV
c. Trash = Incorrectly scanned documents
Contact
If you have questions regarding the pre-screening process, please do not hesitate to contact us at
Let us know if you would like to schedule a personal telephone call