Q. What platforms
does DMSys run on?
A. DMSys can
be installed on any computer running Windows 2000 or later.
Is DMSys fully GCP and 21 CFR Part 11 compliant?
A. Yes. First, DMSys
is fully validated. This does not simply mean that it has been thoroughly
tested; its development has also been fully documented.
Second, DMSys provides a complete audit trail. For any data
entering the system through first data entry, verification (second
data entry) or the data import function, an audit trail is maintained.
Additionally, a full audit trail is maintained for any corrections
and changes to data including the reason for making the correction.
incorporates all the security features required by GCP and 21 CFR
Part 11. Every authorized user must have a user name and password;
both have to be recognized by the system before they can log in.
Users are required to change their passwords at regular intervals.
A record is kept of all user log-ins and log-outs, with the name
of the user, and the date and time of all user log-ins and log-outs,
with the name of the user, and the date and time they entered and
exited. Each functionality and individual study in DMSys
is protected. A user must have the authorization in their user access
profile to access each specific function and study in DMSys,
so that, for example, a user who is not authorized to enter data
corrections is unable to do so.
Q. How is double
data entry done in DMSys?
A. Verification (double
data entry) can be performed interactively or non-interactively.
In both cases, two distinct data files are created.
In non-interactive verification, the second data entry operator
never sees the entries made by the first operator; data entry and
verification are identical processes. After completion of verification,
DMSys provides the facility to compare the entries made by
the two operators, and print out any discrepancies (including any
records present in one field but missing from the other).
In interactive verification, the second data entry operator does
not see the entries made by the first, unless a different value
is entered. Then, the operator is presented with three options:
to re-edit the value, to accept the original value, or to accept
the second value.
Q. Are character
values checked when comparing values entered originally and on verification?
A. When comparing the
values entered in non-interactive verification, memo fields (character
fields of unlimited length) can be excluded. In interactive verification,
all fields are compared.
Q. Is double data-entry
required by DMSys?
A. No. If you are conducting
or managing a study for which you believe double data entry to be
unnecessary, you do not have to do it. In validating data, creating
master files, and many other procedures, DMSys looks for verification
file, but if it cannot find one, it defaults to the data entry file.
Q. Does DMSys allow
data checking during data entry?
A. Yes, DMSys
does provide the facility to perform range checks on data during
data entry. It's an option that can be switched on or off. When
it's switched on, the user is notified of any out-of-range values.
The user can then immediately re-edit the entry, if the out-of-range
value is a data entry error. However, since GCP requires the data
entry operator to enter exactly what is written on the CRF, the
operator can also leave the out-of-range value in place to be picked
up by the validation checks run after completion of data entry.
Q. Does DMSys provide
any management metrics
A. Yes. During data
entry and verification (both interactive and non-interactive), the
time taken to enter each record is recorded in the 'history' file.
In interactive verification, the number of discordant values and
the number of modifications per record are also stored, and can
be browsed or printed if wished.