Research SMQ/CQ Data Flow

pharmaverse / admiral

ADaM in R Asset Library

https://pharmaverse.github.io/admiral

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Research SMQ/CQ Data Flow #164

Closed thomas-neitmann closed 3 years ago

thomas-neitmann commented 3 years ago

Please research where SMQ/CQ/drug basket information is stored on your system and the current "flow" of the data until it is merged onto an ADaM dataset. The goal is to agree on a common data format that would serve as input for an admiral function.

esimms999 commented 3 years ago

Some background info:

MedDRA (Medical Dictionary for Regulatory Activities): https://www.meddra.org/
New versions twice/year (March and September)
Every Regulatory Agency wants the latest version of MedDRA, at time of study submission, used for encoding.
Submissions must have codes for PT (Preferred Term). There may be additional reporting based on LLT (Lowest Level Term).
GSK ADaM specs for SMQ* and CQ:

bundfussr commented 3 years ago

Hi @esimms999 , thanks for the information. I have created a document at box and copied your information to it. I have added some information from Roche. @millerg23 , could you have a look and add and update?