Bioequivalence and Bioavailability Forum • Traceability

Traceability [General Statistics]

posted by Helmut – Vienna, Austria, 2023-02-11 14:22 (48 d 14:36 ago) – Posting: # 23455
Views: 723

Hi Sereng,

❝ Hi Helmut, I am not sure whether my reply should be at the top or bottom in this forum.

See here and there.

❝ Do you include your BA/BE study SAP with you NDA?

Whatever you planned must be included as appendices to the report. Only then your results are traceable from the raw data.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Are Statistical Analysis Plans “required” for Pivotal Studies? Sereng 2023-02-08 18:23 [General Statistics]
- SAP vs. part of the clinical protocol Helmut 2023-02-09 09:49
  - SAP vs. part of the clinical protocol Sereng 2023-02-10 23:34
    - TraceabilityHelmut 2023-02-11 13:22
- Are Statistical Analysis Plans “required” for Pivotal Studies? Achievwin 2023-02-15 12:07
- Are Statistical Analysis Plans “required” for Pivotal Studies? ElMaestro 2023-02-16 06:55

Admin contact
22,559 posts in 4,725 threads, 1,607 registered users;
14 visitors (0 registered, 14 guests [including 7 identified bots]).
Forum time: 05:58 CEST (Europe/Vienna)

The penalty for scientific irrelevance is, of course,
that the statistician’s work is ignored by the scientific community. George E.P. Box

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz