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 (02Jan2012) Version 2012-1 has many improvements
to the program interfaces, mostly for cosmetic reasons. For best support and
fewest problems, keep your system up-to-date. We currently recommend Windows 7,
screen reslolution 1280 x 1024 and Excel 2002 or newer.
(24Mar2011) Version 2011-3 adds a new feature to
the Survive program: direct export of K-M or plot data to Excel.
(27Jun2010) Version 2010-6 uses a new install
program which satisfies the requirements of Windows 7, as well as all previous
versions of Windows. MEDLOG no longer
makes updates to the Win.ini file (which Windows 7 doesn’t like), but uses a
new file called MedUsers.ini, now located in the “MED” folder, or wherever
you install MEDLOG.
The maximum dictionary size is now 4000 variables. (If your dictionary has a large number of
float variables, you may hit other limits before 4000).
A new feature (under the Help menu) lets you
record notes about the databank that you might otherwise keep in paper
records. For example, you might record when and why a study protocol was
changed, or when a new person took over responsibly for the databank. Each
databank maintains its own note file. The Databank Notes will work just like
a note variable, except it belongs to the databank, not a patient in the
databank. Access to Databank Notes requires data entry or dictionary
privileges.
A useful option has been added to the Form program. If
"!OPTIONS COLOROPT" is at the top of a form, then the underline
(used to indicate were the data is entered) will be colored blue for
time-variant variables, green for time-invariant, and fuchsia for any local
form variables. Without this option, the underlines are always blue.
The Build program has features which can be useful in
"cleaning up" text files and tables. For a discussion of Build's
capabilities, click HERE.
Version 2005 and later allows the previous limit of 1500
variables per databank to be increased. The new limit is now 2500 variables.
No change to any existing databank is required. The increase can be set in
"databank options-reset mode". The option is not reversible once
set.
Release 2004-6 and later releases have new security features
which are recommended in FDA guidelines 21 CRF Part 11. These include
expiration dates for passwords and automatic timeouts if a workstation is
unattended for some time period. For more details, click HERE.
Watch out for emails containing viruses. Please note that we do
not send any bulk emails. All of All our emails are replies to you or have a
very clear subject line. If you have any doubts, call or email us before
opening any attachment which appears to come from MEDLOG, but you were not
expecting. Do not open any attachments you receive from unknown sources.
Clinical trial management involves keeping track of the entry
and verification of case report forms. Establishing an automated method for
this is not difficult in MEDLOG. Click HERE
for more info.
A special-purpose program called Disable is available on
request. The purpose of this stand-alone program is to disable portions of
the main menu after installation. This program will be sent by email to
authorized customers who request it.
Release 2003-5 includes a new form data entry capability: forms
which are designed around graphics instead of text. Click HERE for more info. Also, the design of "pretty"
looking data entry forms requires vertical alignment between lines. This can
now be done properly with tabs. To see the details, click HERE.
Some customers have experienced difficulties with tables after
installing the latest versions on MEDLOG2K. If you receive the message
"Version incorrect" or similar, you may have an installation
problem involving the Borland Database Engine. For a solution to this
problem, click HERE.
Substantial additions have been made to the Form program over
the years. These include new options to control how a form terminates, a new
display (popup) field action, a new file print (.jpg) option, longer form
names and improved font displays. For more information, click HERE. Also, for information on how to manipulate
text variables in the Form program, click HERE
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Stringent FDA software procedures may require that you
"validate" your MEDLOG installation when you update MEDLOG
versions. To help you do this we have provided a validation checklist and a
test databank. The checklist is a word document (about 15 pages), click HERE for a copy. The test databank VAL is
a zip file, to download it, click HERE
The ability to have control over the processing and actions of
the fields on a form is one of the best features of MEDLOG. It is easy to
specify the initial actions for a form by having a field statement for the
first field on the form. It is more difficult to do the same for the last
field because the entry clerk may stop the process early with a click on
"complete", or another field may goto [!end] and bypass the rest of
the form. To remedy this, a field specification may now be added which will
be processed whenever the form terminates. Merely add a [!end] field
specification to the fields portion of the form. The actions specified for
this field will be done before the "any changes" message is given.
Printers: software developers agree that the variety of printers
and printer connections are a major source of aggravation. One problem seen
recently was printing from the Form Designer-Editor program. The line drawing
font characters were not displayed correctly. The problem was corrected by a
change in the printer options in the Windows control panel. The Font option
was changed from "Download TrueType fonts" to "Print TrueType
fonts as graphics". If you are having any trouble printing, please call
and we should be able to help you make the necessary system settings.
Security is a concern in the validation of clinical trials and
regarding the privacy of patient records. A new feature has been added to
MEDLOG which will record the date/time and initials of the operator each time
a databank is opened for any purpose. This feature must be enabled in the
Databank Options program (audit trail options). A new file named ACCESS.MED
will be created in the databank folder. It may be set to "write
only", if you wish. The file may be read with Notepad or similar. The
manual will be updated to reflect this addition.
US
companies conducting clinical trials for the FDA should know that MEDLOG is
fully compliant with the FDA requirements for Electronic Records, 21 CFR Part
1l. In particular, the audit trail files and the password access are
addressed by this regulation. Also, the access feature just added (see above)
provides additional audit information regarding data access, beyond changing
or adding data. Questions regarding MEDLOG compliance may be directed to us
by email at medlog@medlog.com. To view our statement regarding software
validation, click HERE.
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