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:
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.