This usually describes the management plan for the data collected during the project. It is a brief description or synopsis of the protocol.
The protocol, in terms of a clinical research study, is the plan, or blueprint, that
describes the study’s objectives, methodology, statistical considerations, and the organization of the study. [CDISC.org Oct. 2012]
What to look for when reading a protocol?
- Review of T&E – Time and Event Schedule or Visit Schedule.
- Assessments e.g. ECGs, PE (physical exams), MH-MedHix or Medical HIstory, labs and more.
- Critical data variables for analysis. e.g. efficacy and safety data
proc print data= work.demog;
where patient in(“&pid”) and page=’3′;
var patient SBJINT page
dob sex bmi weight height;
title ‘Page 3 – Demog’;
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Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.