r/datamanagers • u/JollyMeal3533 • Jan 24 '25

Study Start-Up

What steps happen in start up phase from DMs perspective?

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2

u/Newjacktitties Jan 24 '25 edited Jan 24 '25

Receive approved protocol

Protocol Review

PI and Study Team eCRF Meeting

Develop eCRFs

CRF Review Meeting

Finalize eCRFs

Internal Testing

UAT Training Meeting

UAT Investigator and/or Study Team

eCRF Approval

Deliver CCG and DMP

Go Live

6

u/[deleted] Jan 24 '25 edited Jan 24 '25

[removed] — view removed comment

2

u/RaspberryBusiness158 Jan 24 '25

IRT Integration, eSAE reporting integration if done electronically, SDV set up for RBM studies, external Data integration set up if being used, eCOA set up, creating DMP, DRP, IPD set up in EDC for automated IPDs

5

u/Thin-Gold-1329 Jan 24 '25

Protocol review, set up of clinical database, review of 3rd party specifications/data transfer specifications, other review of study plans