Study Site Provided - S1400 Sample Documents

The source and sample documents were shared by participating S1400 study sites and approved by the Lung-MAP Site Coordinator Committee (SCC). Members of the SWOG Quality Assurance audit team and/or the Data Coordinators reviewed the documents and approved them for posting on the S1400 abstract page.

We encourage sites to download the documents and revise them as necessary for their own use.

PLEASE NOTE: These documents were developed from previous versions of the protocol. Sites who wish to utilize the documents are responsible for updating them to the current approved protocol.

Some editing may have been done to the original document and instructions to make them more generally applicable.

• Patient AE LOG
  A cumulative AE log for each patient. The study requires AE start and stop dates and verbatim terms, the cumulative AE log ensures informaiton is captured consistently. Helpful hint from site: they keep attached to the AE log the last RAVE AE form so the research nurse can visualize the continuing AEs being tracked from the prior cycle.

   

• RECIST Tracker
  This worksheet is used for S1400D to track progression throughout the study. Utilizing this worksheet keeps response assessments consisten. The information cut/pasted from this sheet into the CT Reminder Letter.

   

• CT Reminder Letter
  This is provided to the attending radiologist in advance of the CT scan to help ensure the readings are consistent to protocol requirements. This is a sample of the fax sent to outside radiologist.

   

• Progress Note: Pre-Screening for Biomarker Profiling
  This is a progress note to guide nurses through the visits for S1400 drafted from the protocol, form set, and RAVE guidelines. They helped ensure source documentation for all the visit requirements, ensure clinical trial billing is handled appropriately, and RAVE entry and TRIAD submissions are performed when required. They can easily be modified for the other sub-studies as needed.

   

• Progress Note: Pre-Screening End of Front Line Treatment Regimen
  This is a progress note to guide nurses through the visits for S1400 drafted from the protocol, form set, and RAVE guidelines. They helped ensure source documentation for all the visit requirements, ensure clinical trial billing is handled appropriately, and RAVE entry and TRIAD submissions are performed when required. They can easily be modified for the other sub-studies as needed.

   

• Progress Note: Progression Surveillance
  This is a progress note to guide nurses through the visits for S1400 drafted from the protocol, form set, and RAVE guidelines. They helped ensure source documentation for all the visit requirements, ensure clinical trial billing is handled appropriately, and RAVE entry and TRIAD submissions are performed when required. They can easily be modified for the other sub-studies as needed.

   

• Progress Note: Screening Prior to Sub-Study Registration
  This is a progress note to guide nurses through the visits for S1400D drafted from the protocol, form set, and RAVE guidelines. They helped ensure source documentation for all the visit requirements, ensure clinical trial billing is handled appropriately, and RAVE entry and TRIAD submissions are performed when required. They can easily be modified for the other sub-studies as needed.

   

• S1400D Progress Note
  This is a progress note to guide nurses through the visits for S1400D drafted from the protocol, form set, and RAVE guidelines. They helped ensure source documentation for all the visit requirements, ensure clinical trial billing is handled appropriately, and RAVE entry and TRIAD submissions are performed when required. They can easily be modified for the other sub-studies as needed.

Contributer:
Marianne M. Yohn, MMGT, CCRP
Clinical Trial Data Specialist
Susquehanna Health Cancer Center
myohn@susquehannahealth.org
SusquehannaHealth.org