Bioequivalence and Bioavailability Forum

SAS only? [Software]

posted by WhiteCoatWriter – India, 2019-03-25 10:39 (1998 d 19:33 ago) – Posting: # 20080
Views: 8,469

Hello Helmut.

❝ Right. The FDA’s Technical Specifications Document (January 2019) states:

❝

4.1.4.2 Dates in SDTM and SEND

❝ Dates in SDTM and SEND domains should conform to the ISO 8601 format.

❝ I was confused because you wrote:

❝

❝ ❝ ❝ ❝ Also, when it comes to Adam datasets it specially requires SAS date format […]

Well that is true as to what FDA states and is applicable in the SDTM datasets, However in Adam datasets, especially ADSL datasets under certain variables such as treatment start and end, it requires SAS date format, only then we get a successful validation report from Pinnacle 21 (I have tried ISO 8601 and have got validation errors stating "variable is not in sas date format")

❝ Sorry, I don’t have an account and don’t want to get one.

❝ P.S.: You can add a signature in your profile (SOP). Saves a few keystrokes in future posts.

Thanks for the tip. worked it out.

Complete thread:

• CDISC datasets or R. Acceptable ?? WhiteCoatWriter 2019-03-21 07:13 [Software] 
  • CDISC datasets from R. Why not? Helmut 2019-03-21 10:47
    • CDISC datasets from R. Why not? WhiteCoatWriter 2019-03-21 12:13
      • CDISC datasets from R. Why not? Helmut 2019-03-21 16:43
        • CDISC datasets from R. Why not? WhiteCoatWriter 2019-03-22 06:56
          • Some code Helmut 2019-03-22 16:58
            • Some code WhiteCoatWriter 2019-03-24 07:59
              • SAS only? Helmut 2019-03-24 12:34
                • SAS only?WhiteCoatWriter 2019-03-25 09:39
                  • Confusing… Helmut 2019-03-25 13:44
                    • Confusing… WhiteCoatWriter 2019-03-27 06:55