Section 5.4.12

[Pauline Moore]

Section 5.4.12 Monitoring visit follow-up documentation. Is this section no longer applicable as it is recommended that monitoring follow up letters can now be filed in section 5.3.3 along side the monitoring visit report. Will this section be remove in the next DIA model update?

[Eldin Rammell]

Hi Pauline,

Section 5.4.12 provides flexibility for those sponsors who wish to keep the follow-up documentation separate; they may not have the ability to use sub-artifacts to help specifically search for follow-up records. If section 5.4.12 was removed, sponsors who adopt the Reference Model would then be forced to file follow-up documentation in the same location as the original monitoring visit records (section 5.4.3) and may be more difficult to locate without the use of sub-artifacts.

Kind regards,
Eldin.

[Author]

Posts