Source: http://www.stampedetrial.org/centres/protocol-amendment-pack/
Timestamp: 2020-08-14 01:41:17
Document Index: 35813548

Matched Legal Cases: ['art 1', 'art 1', 'art 3', 'art 3', 'art 3', 'art 3']

Protocol Amendment Pack | STAMPEDE
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
Protocol V19.0 Clean (June 2018)
Protocol V19.0 Tracked (June 2018)
Appendices V18.0 Clean (June 2018)
Appendices V18.0 Tracked (June 2018)
Participant Treatment and Additional Research Consent Form V18.0 Clean (July 2018)*
Participant Treatment and Additional Research Consent Form V18.0 Tracked (July 2018)*
PIS Additional Research V15.0 Clean (July 2018)
PIS Additional Research V15.0 Tracked (July 2018)
PIS General Part 1 & 2 V18.0 Clean (June 2018)*
PIS General Part 1 & 2 V18.0 Tracked (June 2018)*
PIS General Part 3 ARM K V4.0 Clean (July 2018)
PIS General Part 3 ARM K V4.0 Tracked (July 2018)
PIS General Part 3 ARM L V3.0 Clean (July 2018)*
PIS General Part 3 ARM L V3.0 Tracked (July 2018)*
*New version released: please refer to current essential documents.
Ethics & Regulatory Documents
REC Approval (01-Oct-2018)
REC Cover Letter (21-Sep-2018)
MHRA Approval (12-Oct-2018)
MHRA Cover Letter (10-Sep-2018)
MHRA / REC Submission Form (21-Sep-2018)
HRA Approval (21-Sep-2018)
HRA Categorisation
Updated IMP Documents
Abiraterone IB V13.0 Addendum
Enzalutamide IB V10.0
Metformin Trial Specfifc Label Arm K SR BID V3.0 (July 2018)
Manufacturer Authorisation IMP Licence - ALMAC
New Participant Letters
Comparison Closure - Participants Stopping Follow Up
Comparison Closure - Participants Continuing Follow Up
Updated Working Documents
Pharmacy Information Sheet V17.0 (Oct 2018)
Sample Collection & Handling Manual v7.0
CRF Version History v1.0
Self Evident Corrections (SECs) v1.0
ISF Self Assessment Checklist (Dec 2018)
PSF Self Assessment Checklist (Nov 2018)
STAMPEDE Personnel & Delegation Log v4.0
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.
Protocol v19.0 Activation Checklist
Protocol v19.0 PI Statement
Protocol v19.0 Acknowledgement - Research Team (Recruiting Site)
Protocol v19.0 Acknowledgement - Pharmacy (Recruiting Site)
Protocol v19.0 Acknowledgement - PI (Recruiting Site)
Protocol v19.0 Acknowledgement - Research Team (Follow up Only Site)
Protocol v19.0 Acknowledgement - Pharmacy (Follow up Only Site)
Protocol v19.0 Acknowledgement - PI (Follow up Only Site)
"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.
Comparison Closure Checklist v1.0
Page last updated: 05-Aug-2020 12:13