Data lock point

For a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in a PSUR. For a periodic benefit-risk evaluation report (PBRER), the date designated as the cut-off date for data to be included in a PBRER, based on the international birth date (see GVP Annex IV, ICH-E2C(R2) Guideline).

For a development safety update report (DSUR), the date designated as the cut-off date for data to be included in a DSUR, based on the development international birth date (see ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

Date includes day and month (see ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

See also Periodic safety update report, Development safety update report, International birth date, Development international birth date