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T2020-004 Trametinib

Protocol Opened: 9/21/2023

Study Contacts

  • Protocol Chair & Protocol Biology Chair: Elliot Stieglitz, MD
  • Protocol Vice-Chair: Mignon Loh, MD

 

CURRENT STUDY DOCUMENTS

T2020-004 Trametinib Study Protocol Amendment #1 Tracked 
T2020-004 Trametinib Study Protocol Amendment #1 Clean
T2020-004 Trametinib Study Protocol Amendment #1 Approval Letter
T2020-004 Trametinib Protocol Amendment #1 Master Consent v. 11.5.2024
T2020-004 Trametinib Protocol Amendment #1 Master Assent
T2020-004 Trametinib Protocol Amendment #1 Master Addendum to the Consent
T2020-004 Trametinib Eligibility Worksheet 
T2020-004 Enrollment Procedures Video Training
T2020-004 Trametinib Research Monitoring Plan 
 T2020-004 Trametinib Investigator Team Training Link
 T2020-004 Trametinib Investigator Training - Slides 
T2020-004 Trametinib Investigator Training Log Template
T2020-004 Trametinib Investigator Acknowledgment version 14FEB2024
T2020-004 Trametinib Investigator Brochure version 17
T2020-004 Trametinib Investigator Financial Disclosure Form 
T2020-004 Trametinib FDA Form 1572 Template 
T2020-004 Trametinib TACL Delegation of Authority Template
T2020-004 Continuing Renewal 2025-26

 

PREVIOUS STUDY DOCUMENTS

T2020-004 Trametinib Original Protocol 
T2020-004 Trametinib Investigator Acknowledgment version 29AUG2023
Site Activation Requirements Memo
- Reliance Packet, SMART IRB and TACL Operations General Study Start up Requirements
Adverse Events, SAE/DLT and AE Reporting Manual
Study Sample Form & Lab Manual
Roadmaps & Weekly Reports
Enrollment & Eligibility
Drug Logistics & Pharmacy Manual
eCRF Completion Guidelines
Data Safety & Progress Reports
External SUSARs from Novartis
FAQ -Reliance Packet Status