Log in
Register|
jag009 ★★★ NJ, 2026-05-18 08:23 (16 d 18:24 ago) Posting: # 24624 Views: 713 |
|
|
Hi, Does anyone know if CDISC dataset format (STDM and ADAM) is required for submission to UK and EU? I google searched and the answer was it is not required but recommended by UK and EU so to streamline and accelerate the regulatory review process. I know it's required by FDA. If not CDISC, what dataset format is required by UK and EU? Thx J |
|
Helmut ★★★   Vienna, Austria, 2026-05-18 10:25 (16 d 16:22 ago) @ jag009 Posting: # 24625 Views: 649 |
|
|
Hi John, ❝ Does anyone know if CDISC dataset format (STDM and ADAM) is required for submission to UK and EU? I google searched and the answer was it is not required but recommended by UK and EU so to streamline and accelerate the regulatory review process. ❝ If not CDISC, what dataset format is required by UK and EU? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
jag009 ★★★ NJ, 2026-05-18 16:05 (16 d 10:42 ago) @ Helmut Posting: # 24626 Views: 607 |
|
|
Thx Helmut, ❝ ❝ If not CDISC, what dataset format is required by UK and EU? ❝ Any. If you want to avoid time-consuming requests, keep it simple and avoid proprietary formats. A scanned PDF of a table of analytical results is not a good idea." Can we submit the same format as what is submitted to Canada? Here are what my RA submitted to Canada --> "study-001.dat, study-001.inf, study-001.pkv" dat concentration, pkv = pk parameters, inf = study information file (i.e, study info, content inside the PKV and DAT). For the Canadian study RA sent in non-xpt file (looks like ASCII LoL) instead of XPT... thx John |
|
Helmut ★★★ Vienna, Austria, 2026-05-18 16:31 (16 d 10:16 ago) @ jag009 Posting: # 24627 Views: 598 |
|
|
Hi John, ❝ Can we submit the same format as what is submitted to Canada? Here are what my RA submitted to Canada --> "study-001.dat, study-001.inf, study-001.pkv" ❝ dat concentration, pkv = pk parameters, inf = study information file (i.e, study info, content inside the PKV and DAT). For the Canadian study RA sent in non-xpt file (looks like ASCII LoL) instead of XPT... — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
jag009 ★★★ NJ, 2026-05-18 16:55 (16 d 09:52 ago) @ Helmut Posting: # 24628 Views: 599 |
|
|
Thanks Helmut. Lets see what my Euro RA goons would say. john |
|
zizou ★ Plzeň, Czech Republic, 2026-05-22 18:49 (12 d 07:58 ago) @ jag009 Posting: # 24630 Views: 415 |
|
|
Dear John, I agree with Helmut. Just for curiosity, there could be problem with sending the *.inf file by the mail. When I attach the *.inf file into the mail and I click "Send" button, pop-up window appears with Warning. After sending the mail anyway, the file disappers from the mail. Maybe it would be easier to save all data in more common format for not problematic sending of files (valid at least for me). Best regards, zizou |
Ing. Helmut Schütz