Data Management Resources

Lost to Follow-up

A patient will be deemed lost to follow-up if the site has been unable to get ANY vital statistics information related to the patient for 2 continuous years. Attempts to locate the patient are expected to continue during this 2-year period.

• Lost to Follow-Up Guidance Document
  See: NRG Oncology Lost to Follow-up Guidance Document for instructions and contact information regarding patients that are considered lost to follow-up.
• Never Say Lost
  Booklet for minimizing number of patients who become lost to follow-up. Click here for booklet. 

Consent Withdrawal

The Consent Withdrawal process should be followed when the participant no longer wishes for his or her records to be included in the research project. He or she no only refuses contact with the research team, but also does not want his or her health care providers contacted for information.

• Use of Consent Withdrawal Process
  The "Consent Withdrawal Process" should be followed when study participants no longer wish to have their records included in the research project. For more information see: Consent Withdrawal Process. 

Adverse Events

• Routine AE Reporting Guidance Document
  See: Routine AE Reporting Guidelines for information regarding routine adverse event reporting in NRG Oncology clinical trials.

Site Request for Early IRB Closure

CTSU's Request for LPO Approval of Early Closure Form is now available on the CTSU website under Resources > CTSU Operations Information > CTSU Forms. See additional NRG Instructions.

Medidata Rave Resources

• Medidata Rave FAQs - Updated April 15, 2018
  See: Medidata Rave FAQs on how to obtain a user account and use Rave. 

PRO Resources

• Collecting PROs via Telephone or Mail
• PRO Frequently Asked Questions
• Reasons to Collect PROs
• Best Practices for NeuroCognitive Test Completion
• ePRO FAQs
  See: ePRO FAQs on how to access and use the patient cloud and ePRO items.