Notice of Updated DF/HCC Policies - Effective January 31, 2019

December 03, 2018

Summary of Revisions
DF/HCC Policies, Operations, and Related Documents
Changes Effective: January 31, 2019

No formal documentation of training on the following policy updates is required, per EDU-100. Below is a summary of key revisions. Tracked versions are available for review on the DF/HCC website – Policy Updates Page.

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Updates to Policy Content and Requirements

ADM-100: Creation and Maintenance of DF/HCC Policies and Operations

  • Added comprehensive definition of Human Subject Research as it applies to DF/HCC research and policies.

DATA-100: Data Management of Investigator-Sponsored Therapeutic Protocols

  • Combined with DATA-103 (to be retired on 1/31/19)
  • Updated to reflect current data request, missing forms report, and data management requirements. Language regarding paper CRFs removed.
  • Updated/New DF/HCC Operations
    • DATA-OP-1: Data Requests (updated)
    • DATA-OP-2: Obtaining Missing Forms Reports (new)

MULTI-100: DF/HCC Investigator-Sponsored Multi-Center Research

  • Updated with single IRB requirements from the revised Common Rule.
  • Clarified what is considered an External Site engaged in human subject research and the requirements for training and approval.

RCO-204: Confidentiality and Secondary Use of Research Information

  • Clarified IND safety report review language. Note that the use of portals is acceptable to DF/HCC when accompanied by direct notification. DF/HCC recognizes that sponsors may use different methods to communicate the unanticipated problem determination and fulfill their regulatory obligations.

RCO-205: Reporting of Protocol Deviations, Violations and Exceptions

  • Updated with single IRB requirements from the revised Common Rule.

REGIST-100: Eligibility Checklists

  • Section 5.2: ODQ will now create standardized eligibility checklists using the IRB-approved protocol document. For more information, please see the FAQ on this change.
  • Combined with REGIST-104 (retired as of 1/31/19)
  • New DF/HCC Operation:
    • REGIST-OP-3: Eligibility Checklist Development

REGIST-101: Subject Registration

  • Combined REGIST-101A and 101B (centralized vs. decentralized registrations)
  • Section 5.5.: Clarified the study team’s responsibility for updating subject information in OnCore for randomized trials where the initial registration/randomization is performed centrally by ODQ.
  • Section 5.7.: Updated to allow for summary accrual reporting in limited situations
  • Updated DF/HCC Operation:
    • REGIST-OP-1: Subject Registration

Reorganized and Combined Policy Language

AUD-100: Audits and Inspections

  • Combined with AUD-101 (retired as of 1/31/19) to create one comprehensive policy for both internal audits and external regulatory inspections.
  • Updated/New DF/HCC Operations and documents:
    • AUD-OP-1: Internal Auditing Procedures
    • AUD-OP-2: FDA and Other Regulatory Inspections
    • DF/HCC External Regulatory Inspections Contact List

COM-100: Human Research Oversight and Operations Committees

  • Combined with COM-101, COM-102, and COM-103 (retired as of 1/31/19) to create one comprehensive policy for DF/HCC oversight and operations committees.
  • New DF/HCC Operations:
    • COM-OP-2: Accrual Monitoring Procedures and Criteria
    • COM-OP-3: CLINOPS Procedures
    • COM-OP-4: CLC Procedures
    • COM-OP-5: DSMC Procedures, Review and Data Compliance
    • COM-OP-6: DSMB Procedures and Review

DOC-100: Research Subject Documentation

  • Combined with DOC-100, DOC-101 and DOC-102 (retired as of 1/31/19) to create one comprehensive research documentation policy.
  • Clarified requirements regarding confidential questionnaires in section 5.2.1.2

RCO-100: Responsibilities of the Sponsor Conducting Research Involving a Drug

  • Minor administrative updates throughout to update references and policy language.

RCO-101: Responsibilities of the Sponsor Conducting Research Involving a Device

  • Minor administrative updates throughout to update references and policy language.

RCO-102: Responsibilities of Investigators

  • Combined with RCO-206 (retired as of 1/31/19)
  • Minor administrative updates throughout to update references and policy language.

RCO-103: Confidentiality and Secondary Use of Research Information

  • Combined with CON-103 (retired as of 1/31/19).
  • Title updated to reflect combined content.

RCO-203: Regulatory Documentation

  • Combined with RCO-200, RCO-201, RCO-202 (retired as of 1/31/19) to create one comprehensive policy on regulatory documentation.
  • Section 5.2.1.1: IRB-determined minimal risk research is exempt from delegation of authority log requirement.
  • New Operations and Documents:
    • RCO-OP-3 Completing the FDA Form 1572.
    • DF/HCC Regulatory File – Required Document List

Other New/Revised Documents:

  • DF/HCC Site Management Plan
    • Updated throughout to align with current DF/HCC Policies and institutional practices.

Retired Policies – Effective 1/31/19

  • COM-101 (Combined with COM-100)
  • COM-102 (Combined with COM-100)
  • COM-103 (Combined with COM-100)
  • CON-103 (Combined with RCO-103)
  • DATA-103 (Combined with DATA-100)
  • RCO-200 (Combined with RCO-203)
  • RCO-201 (Combined with RCO-203)
  • RCO-202 (Combined with RCO-203)
  • RCO-206 (Combined with RCO-102)
  • RCO-207 (Converted to DF/HCC Operation)
  • REGIST-104 (combined with REGIST-100)

 

Notice of Administrative Update: All DF/HCC Policies and supporting documents were updated to reflect the departmental name change of Research Informatics Operations (RIO) [formerly the Clinical Trials Research Informatics Office (CTRIO)] and job title for Office of Data Quality (ODQ) Clinical Research Systems Specialist [previously Protocol Systems Coordinator (PSC)].