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WhatWentWrongForm edit

Title A Sponsor's Responsibilities
Contributor/Email MaryBanach
Type_of_Study Diagnostic Tiral
Description - Problem(s) encountered A sponsor did not have time to monitor a diagnostic trial for a cancer marker. A contract was made with an outside agency to monitor the trial. The specimens were collected at community screening. In completing the CRFs, the site investigator said that they did not have records on cancer disposition on most of the subjects. The site investigator asked if it will alright if they called the patient to find out if the patient had cancer. The outside agency monitor said that that would be fine. When the sponsor received the data and asked for verification of cancer, the sponsor was told that there was no verification. The sponsor then worked with the site to verify cancer disposition. Some of the subjects were lost to follow-up during this time.
Type_of_Lesson Procedures incomplete, Problems with oversight
Other_Lessons

Lesson(s)_Learned The sponsor must always clearly state in the protocol how the outcome will be verified. The sponsor must spell out and oversee the work of the outside agency. The outside agency should provide the sponsor with a clear list of their responsibilities on the clinical trial and how they will be working with and monitoring the clinical trial sites.
Effects The submission was delayed. The sponsor was able to provide an adequate number of verifications for the clinical trial claims. Luckily the sponsor did not have restart and recruit additional subjects for the trial.
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 - 13:54:18 - MaryBanach
 

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