CSR Development - Part II

1) The clinical data base lock (CDBL) for an adult interventional trial should be completed by?

No later than LPLV + 3 weeks

No later than LPLV + 6 weeks

No later than LPLV + 12 weeks

No later than LPLV + 16 weeks

2) The PK lock for an adult interventional trial should be completed by?

No later than LPLV + 4 weeks

No later than LPLV + 8 weeks

No later than LPLV + 12 weeks

No later than LPLV + 16 weeks

3) All planned outputs (TLFs) for an adult interventional trial (including additional data driven analysis, if any) should be available by:

No later than LPLV + 16 weeks (4 months)

No later than LPLV + 20 weeks (5 months)

No later than LPLV + 24 weeks (6 months)

No later than LPLV + 28 weeks (7 months)

4) All components of an adult interventional trial CSR (core CSR, synopsis, reference list, patient narratives, TLFs) should be content final (no additional comments or revisions are expected) and ready to be promoted through CREDI lifecycle by:

No later than LPLV + 24 weeks (6 months)

No later than LPLV + 28 weeks (7 months)

No later than LPLV + 32 weeks (8 months)

No later than LPLV + 36 weeks (9 months)

5) Posting of clinical trial results to health authority registries and CTRD should be done by

No later than LPLV + 8 months

No later than LPLV + 10 months

No later than LPLV + 12 months

No later than LPLV + 15 months

6) An addendum template can be used to prepare close out report (final CSR)?

Yes

No

7) How to correct if there are incorrect statements or incorrect data in the final published CSR communicated to HAs?

Note to file

CSR Amendment

CSR Addendum

Terminate the CSR and correct

8) How to add if a critical table, listing or figure was missing in the CSR that is already finalized and published?

Note to file

CSR Amendment

CSR Addendum

Terminate the CSR and correct

9) What type of report should be planned when one or more full CSR (based on an interim DBL) have already been published, if full efficacy and safety data were already reported in previous reports and only few patients were ongoing in the study after the last interim DBL

CSR Addendum

Shortened CSR

Synoptic report

Full CSR

10) If a full CSR was originally planned, and the team decided to go with an abbreviated report, what should be done in such cases?

RAP should be amended to reflect an abbreviated analysis

No RAP amendment required, however the reasons why report is abbreviated should be explained in the CSR