Biomedical Engineering Reference
In-Depth Information
11.4 Tactics of training
record-keeping
Training record-keeping includes training records (or
attendance sheets), training assessments, and curricula or
ITPs. In each case, this is a controlled document; each has
necessary fi elds and optional (“nice-to-have”) fi elds. An
example of a “nice-to-have” feature of a training record
would be a fi eld where a supervisor vouches for the record
creator's qualifi cation.
Training records, for instance, have a number of necessary
fi elds. These fi elds are listed in Table 11.2, insofar as the
documentation corresponds to the fi rst scenario.
The training procedure must not only list each of these
fi elds, plus any optional “nice-to-have” fi elds, but must
indicate the roles and responsible party for each fi eld.
If the training SOP describes a fully electronic scenario
where trainees record their participation in the training
event online, and trainers also record their facilitation
of the event online, the SOP must also describe the fall back
process in the event there are connectivity problems,
training in remote locations, etc. Thus the roles and
responsibilities of the data clerk and data steward are
still critical.
If hard copies are archived following data entry into the
validated LMS, they should be placed in the document
repository with, at a minimum, the following indexing
information: record type, fi le names, date ranges, and
positions (titles of personnel), who are authorized to access
the archived records. Or, by procedure, the hard copies
should be appropriately disposed.