It’s not always big things that make a difference in the efficiency of a clinical trial --- sometimes it’s the smallest things.
The IRT (IWR/IVR) database is no exception to the rule. The incorrect formatting of a fax or phone number, or an extra space in an email address where automatic notifications are to be sent can wreak havoc with the best laid plans. Likewise, an error in the spelling of a field label, or failing to update the name of an internal infrastructure unit like a new email server can cause significant issues and must be corrected.
These and other administrative tasks – like managing vendor (overseer) staff access, correcting a site’s zip code, or updating Help Desk contact info in the system if there are changes during the study – are all part of routine, necessary housekeeping in an IRT system.
There are two ways to approach these administrative updates. One, they can be put through the same multi-step change request authorization and review processes as the clinical data. A formal change request is sent to the client and a signed authorization required for every tweak of the system, regardless of its non-clinical nature.
An alternate approach is to have the client sign an Administrative System Change Authorization (ASCA) form at project startup. The ASCA spells out the types of changes that system administrators at the vendor are authorized to make without additional paperwork and authorization. All changes other than those listed on the form will continue to require full, independent authorization.
The ASCA must be limited to ‘self-evident’ corrections, such as the ones described above. Self-evident corrections are changes for which:
- the need for correction is obvious to all
- the change is indisputable as to the new data value required
- the data involved relates only to the logistics of trial maintenance, with no clinical significance
In the Veracity Logic IRT system, administrative changes are also captured in the system audit trail (as are all other changes to the system).
Since it may not be possible to anticipate at study startup administrative changes that might occur outside the normal list, the ASCA should be regarded as a living document, expanded as necessary during the trial, with the client required to re-approve any and all additions to the list prior to any new changes being made. The savings in time, money, and efficiency in the conduct of the trial is worth taking the time to think through ASCA issues before your study starts.
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