Protocol Version 19.0 Update Pack

 

Below are documents relating to activation for protocol version 19.0. Please see the Tools and Training Materials page for details of protocol version 19.0 training sessions. Please see the Case Report Forms page for details of protocol version 19.0 associated CRFs.

 

Please note: Any sites not activated to protocol version 19.0 by the 31JAN2019 will be paused to recruitment until such a time when the site is able to provide the necessary documentation to activate the protocol amendment.

 

Updated Essential Documents

*New version released: please refer to current essential documents.

 

Ethics & Regulatory Documents

 

Updated IMP Documents

 

New Participant Letters

 

Updated Working Documents

 

Activation

A completed activation checklist along with the  documentation described within the checklist will need to be provided to the STAMPEDE trial team, prior to your site being activated to protocol v19.0. Your site will be provided with a 'green light' email to confirm you are activated to protocol version 19.0.

Sites MUST activate to protocol version 19.0 prior to the 31st of January 2019. Following this day, any sites not activated to protocol 19.0 will be paused to recruitment until they have made the necessary steps to activate the protocol.

Please find below documentation associated with this process.

 

"Comparison Closure"

All sites will be sent a personalised email and a pack in the post for "comparison Closure" describing the necessary actions to take at site and providing site specific tools to assist with the closure process.  Please find below the link to the checklist used to provide sign off to the STAMPEDE team of actions completed at site.

The activities surrounding comparison closure should only be enacted once your site has received the Green Light to protocol version 19.0.

 

 

STAMPEDE

Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy

See the latest News in STAMPEDE through the link to the right.