SOP Updates Effective 1/31/18 - Now Posted!

December 01, 2017

Summary of Revisions

DF/HCC SOPs and Related Documents

Changes Effective: January 31st, 2018

Below is a summary of the most significant revisions. For a comprehensive look at all changes, please review the tracked version of each document on the DF/HCC website.

Significant Changes: Formal Training Required*

RCO-200: Documenting Delegation of Authority

  • Implements a simplified, standard process for documenting delegation of authority at DF/HCC institutions.
  • For more information, please review the e-learning on RCO-200 Version 10 and the New DOA Process (~ 10 mins)
  • Associated templates and reference documents are listed below in the Additional Document Updates section.

*In order to comply with the new process, all research personnel must document their training on RCO-200 version 10 using one of the below:

Content and Administrative Updates: No Formal Training Required

INV-103: Protocol Mandated Drug Taken at Home

  • Reviewed as part of requirement to review SOPs every three years.
  • Minor administrative edit in section 5.2.

MON-101: Research Conduct Oversight by External Sponsors

  • Combined with content from DATA-102, RSU-100 and RSU-101, all of which will be retired effective 1/31/18. Merging of existing language is not tracked.
  • Title and policy statement updated to reflect broader scope of the document.
  • Clarifications to wording and administrative updates to the order or sections to improve content flow. Changes to existing language are tracked.

RCO-102: Responsibilities of Investigators

  • Section 5.2: Inserted requirement for investigators involved in the conduct of NCI sponsored or funded research to maintain annual NCI registration (from retired REGIST-300).

           

Additional Document Updates

Note: These documents are supplemental to the RCO-200 updates and the revised DF/HCC delegation of authority process. They are now posted on the DF/HCC website  for use.

DF/HCC Operation: Documenting Delegation of Authority

  • Instructions for documenting delegation of authority at DF/HCC, in accordance with the updates to RCO-200.

DF/HCC Training and Signature Record

  • Updated from the previous Training Record/Role Matrix to include the capture of individual’s signature and initials.

DF/HCC Delegation of Authority Log Template

  • Word and smart form versions available.
  • Simplified template for use with new delegation of authority process per RCO-200.

DF/HCC Key: Delegation of Tasks for Clinical Research

  • A central key that defines the appropriate tasks for each research role under DF/HCC policy.

DF/HCC External Site Delegation of Authority Log Template

  • For use on DF/HCC Investigator-Sponsored Multi-Center trials at external (non-DF/HCC) sites only (optional).

Retired SOPs – Effective 1/31/18

  • DATA-102 (combined with MON-101)
  • RSU-100 (combined with MON-101)
  • RSU-101 (combined with MON-101)
  • REGIST-300 (NCI registration requirement added to RCO-102)