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)