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WhatWentWrongForm edit

Title New Hires Changing Instructions
Contributor/Email MaryBanach
Type_of_Study Sponsored Clinical Trial, Diagnostic Tiral
Description - Problem(s) encountered A temporary new hire is engaged in mid-trial to speed up data collection. The new hire has many years of clinical experience and decides that the demographic data is not being collected correctly according to her definition of correct demographic data. She decides to change the demographic data on the CRF. She does not have permission to change or access the CRFs; consequently, she instructs the site personnel to use the "Other" and textbox to follow her criteria for demographics.
Type_of_Lesson Procedures not followed, Problems with oversight

Lesson(s)_Learned It is important that sponsors oversee training and the work of new personnel, make sure that personnel can explain what the CRF fields, and review the need to follow a protocol as written.

Effects Improper collection of demographic data can effect the product claims and findings. One of the most important questions that must be answered when testing a new diagnostic product is whether the product works the same for all subjects with and without the disease, when viewed according to demographic parameters. If the test is 100% sensitive and a 100% specific, demographic data would not be a problem. If there are differences in the product's performance by subject demographic parameters and demographic data is not the same throughout the trial, you cannot adequately substantiate the claims.
See Also

Reference_Area Reproducible Research
Disclaimer The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated.
Topic revision: r2 - 09 Apr 2012 - 13:54:41 - MaryBanach

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