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Upcoming Events 
VA Training

We are now providing our Trainings in MS Teams; you no longer have to register to join an event.

Title: Serious Adverse Event (SAE) Reporting for National Cancer Institute's (NCI) National Clinical Trials Network (NCTN) Trials
Date: Friday, June 21, 2024
Time: 12:00 – 1:00 pm Eastern
Target Audience: Research teams that manage NCTN (e.g., SWOG, Alliance, NRG, & ECOG-ACRIN) trials.
Lead Presenter: Stephanie Ferguson, NAVIGATE National Program Manager
Teams Link:  Click here to join the meeting

Objectives: Join Maggie Spillers (SWOG), Sara McCartney (NRG), Rombi Wake-Oliver (Alliance), and Josh Schoppe (ECOG-ACRIN) for a presentation on serious adverse event (SAE) reporting expectations, CTEP-AERS application, practice examples and available resources with an opportunity to ask questions following the presentation.-

SWOG VA Storefront Support Program
The VA Storefront Program application window is now open.  Established NCTN or NCORP sites interested in pursuing membership can find  information and full details in the formal request for applications by using the link below.  The deadline for applications is August 1, 2024.
VA Storefront Support Program - The Hope Foundation

AVAHO 2024
Helpful Resources and Links:
  • VA Participating Members

  • VA Guidelines - Official VA documents pertaining to oversight, development, and research requirements.

  • VA Operational - This page will provide information related to creating a SWOG-VA Consortium and NAVIGATE

  • Accountability of Investigational Agents and Pharmacy Operations - Drug accountability and storage procedures described in this section are required under Federal Regulations and CTEP, DCTD, NCI policy.

  • NCI – CIRB - Instructional guidelines and checklists on joining the NCI – CIRB.

  • FDA/NCI/OHRP Guidance Documents - FDA and OHRP guidance including Human Subjects Protection.

  • Patient Case Records
    In order to be consistent with standard medical care and to be compliant with Federal regulations, each investigator participating in trials must prepare and maintain adequate and accurate source documentation designed to record all observations and other data pertinent to the investigation of each participant (21 CFR 312.62.b).
     
  • SWOG Quality Assurance and Audit
    The purpose of the Quality Assurance Program is to enhance the reliability and validity of clinical trials data through routine monitoring. Audits are designed to provide assurance that the data reported on research records accurately reflect data in the primary patient record and to verify compliance with protocol and regulatory requirements. The program also surveys data management practices at each institution to provide educational support to clinical trial sites regarding data quality, management, and more. These resources can help with clinical trials quality assurance and the audit process.
     
  • SWOG Studies - This page will provide clinical trial links, information and presentations.
     
  • SWOG Training and Additional Educational Resources  -This page provides links to access all SWOG-specific training, including the Clinical Trials Training Course, Early-Stage Investigators Course, SWOG Study Chair Workshop, and more. 
     
  • VA/SWOG Security - Includes CTSU Security Overview, RAVE, FISMA, AG Mednet, and TRIAD links.
     
  • Committee Participation
    Group members are eligible to participate in Group Disease and Research, and Administrative Committees, as well as the various subcommittees. This link will provide information on the nomination process and how to become more directly involved in research and protocol development.
     
  • Funding Resources - Information on funding opportunities through The Hope Foundation.
Questions?