NRG-GY009 – Call for submission of data

TIME SENSITIVE REQUEST

 

 

This information is being provided to Principal Investigators and Lead Research Associates. It is your responsibility to see that this information is conveyed to your satellite institutions in a timely manner.

 

We are approaching the time for interim analysis of GY009 and we request all institutions participating in NRG-GY009 to make a special effort to submit outstanding data. After all relevant data are collected, the analysis can be performed.

 

The GY009 endpoints include progression and death analysis. It is imperative that protocol defined progressions are reported on the status and response forms, treatment completion forms, and follow-up forms appropriately. Please note that if the patient progresses during treatment, the progression data must also be reported on the follow-up form in the Follow Up 01 folder. In addition, it is important that all follow-up forms reporting vital status are as current as possible for analysis.

 

An update to Medidata Rave will be released by mid-October to add two additional questions on the “Tumor Assessment Visit Form” in the Solid Tumor Evaluations 8 week folder. These will appear for all patients and must be answered when released as they will show overdue when the patient has a reported progression at week 8. The response to these questions will assist the study team in determining if patients discontinued treatment for progressions as defined per the modified RECIST criteria per protocol. Please make every effort to submit outstanding data as quickly as possible.

 

Thank you in advance for your efforts and for your continued support of the NRG-GY009 trial.

 

Should you have any questions, please contact the GY009 Data Manager at 412.624.2666.

 

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