DF/HCC Standard Operating Procedure Revisions - Effective August 31, 2016

June 29, 2016

Highlights of DF/HCC Standard Operating Procedure Revisions

Effective: August 31, 2016

 Please note that this is not a comprehensive list of all changes, but a summary of significant updates. Please find the full tracked changes of SOPs and documents here:

http://www.dfhcc.harvard.edu/research/clinical-research-support/document-library-forms-sops-etc/sop-updates/

 Significant Changes: Formal Training Required

 CON-100: Informed Consent Process

  • Section 5.4.3 has been updated. The consenting process must be documented in the medical record for "all interventional research involving a drug, device, biologic, radiation, or surgery."
  • Section 5.4.4 has been edited to be inclusive of electronic consent forms.
  • Section 5.7.3 has been clarified to state that a legally authorized representative is required for persons “who lack capacity to provide informed consent”.

DFHCC Site Management Plan

  • Section 5.0 has been edited to outline the changes in the Centralized vs Decentralized registration process and the change from the QACT to the Office of Data Quality.
  • Section on ‘Study Drug Supply Shipment for Satellites’ has been updated to clarify the process for sponsor shipments directly to DF/HCC satellites.

 Content and Administrative Changes: No Formal Training Required

 ADM-100: Writing and Revising DF/HCC Standard Operating Procedures

  • This S.O.P. has been edited to clarify the procedure for posting ‘Draft’ S.O.P.s on the DF/HCC website prior to the revised S.O.P. “effective date”.

AUD-102: External Audits of DF/HCC Clinical Research

  • The ‘External Audit Contact List of individual names and email addresses has been removed from the body of the S.O.P. document.  This list can be found separately in the ‘DF/HCC Audit Contact List’ which is updated when staffing changes are reported.

CON-101: Informed Consent of Non-English Speakers

  • Section 5.1.5: Text has been added “Interpreter signature is not required when using the fully translated version of the consent form.”

DATA-103:  Case Report form(CRF) Submission Compliance for PI-initiated Protocols

  • This SOP was revised throughout to reflect the new roles and processes for the Clinical Trials Research Informatics Office (CTRIO) and the Office of Data Quality (ODQ).

EDU-103:  Good Clinical Practice Training Requirements

  • Section 4.1: Text has been added to clarify that ‘Individuals participating in only social or behavioral research ‘or minimal risk research’ are excluded from the GCP training requirement.
  • Section 5.1: Text has been added to describe that certificates from Good Clinical Practice courses from pharmaceutical sponsors and/or DF/HCC affiliated institutions may be accepted in place of the CITI GCP training course certificates.  These ‘other’ certificates must be approved by the DF/HCC Medical Director.

EDU-104:  Audit Training Requirements for New Clinical Researchers

  • This SOP, which previously required audit training for sub-investigators, has been retired. Related updates were made to EDU-105 to expand New Investigator training requirements to new Site Responsible Investigators.

EDU-105: Training Requirements for New Investigators

  • Researchers acting as a ‘Site Responsible Investigator’ for the first time are required to complete new investigator training as outlined in this policy.
  • This SOP was revised throughout to reflect the new processes for the Office of Data Quality (ODQ).

MON-100:  Monitoring Phase I Dose-Escalation for PI-initiated studies

  • Section 5.2.2: Revised to state that an updated eligibility checklist must be included with dose escalation amendments.

RCL-100:  Preparation for Site Close-Out

  • Section 5.1.5 was added to clarify that the DF/HCC Lead Site must check-in with all DFHCC non-lead sites to confirm that all their data queries have been resolved and all data is complete.
  • Section 5.2 has been revised to clarify that the PI/study team must confirm that all data cleanup activities are complete, and that the www.clinicaltrials.gov record is up-to-date, including study status and results entry (if required to report results).

RCO-103: Confidentiality of Research Information

  • This SOP was revised throughout to clarify wording and reference newly defined terms (e.g., Research Data).
  • Section 5.5 was entirely re-written with additional requirements for sharing data from PI-initiated trials with third parties.

RCO-202: Research Personnel CVs and Medical Licenses

  • Sections 5.1 and 5.2 have been revised to clarify that CVs and licenses are collected for individuals listed on the protocol specific Form FDA 1572.

RCO-204: Reporting Adverse Events

  • Section 5.6.1 has been edited to add that Nurse Practitioners or Physician Assistants may review the attribution recorded by a research nurse or study coordinator.

REGIST-100: Eligibility Checklist

  • This SOP was revised throughout to remove processes for ODQ development of eligibility checklists. Eligibility checklists are developed by study teams.
  • Section 1 and 5.1 were clarified to state that protocols with eligibility criteria that require registration in OnCore must use an eligibility checklist. Single patient trials are excluded.
  • Section 5.3 was revised to clarify the process for submitting revised checklists either directly to ODQ or with an amendment.

REGIST-101A: Centralized Subject Registration

  • Section 1 was revised to coincide with the phase out of de-centralization date fields in OnCore.
  • Section 5.2.4 was added to indicate that a Protocol Registration Form is used for protocols without eligibility checklists.
  • Section 5.11 has been added to describe additional steps needed to enroll subjects at DF/HCC sites using Epic.

 REGIST-104: Using the Eligibility Checklist

  • This SOP was revised throughout for clarity and flow.
  • Section 5.4 has been updated. Enrollment Monitor review of the subject eligibility is required for greater than minimal risk trials that involve a drug, device, surgery, or radiation. Other greater than minimal risk trials may be exempt from Enrollment Monitor review with approval from the ODQ director.

Other Document Changes

Guidance On Delegation Of Tasks

  • Clarified guidance on AE grading for abnormal laboratory results.
  • Clarified that assessment of expectedness by unlicensed personnel must be based on the IDB. 
  • Clarified that all personnel may perform data query resolution provided appropriate source documents exist to support any changes to the data.