If you’re a new PI, CRC, maybe CRA too There’s a language to learn as the first thing you do. It speaks in three letters, sometimes four, sometimes two, And it makes no sense to anyone who has not been schooled in the lingo of trials and it can be found in all study files. The first thing you learn from ICH E6 is without GCP there’ll be so much to fix. Learn about IECs, IRBs, CROs, plus more ICFs, SAEs, AEs are all core. Your CRA will SDV all the day through Review PROs, CRFs, issue DCFs too Want to continue with this confusion? an “e” in front creates the delusion you’re making things better for the CRC’s life. The PI will tell you it just causes strife. eConsent, eCRF, eCOA, please ePRO, eReg, eTMF FREEZE! Adding more logins and passwords for me, creating more work. Sites do it for free. FIH studies can be SAD sometimes MAD, Their SOPs, QA, and QC are rad. To start needs a CTA, IND too Safety will be monitored by the DMC crew. End of the study doesn’t mean it’s complete. A CDER inspection is always a treat. The newest of acronyms is one you will see It will solve all our problems simply #DCT.

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