DF/HCC Standard Operating Procedure Revisions - January, 2016

January 04, 2016

Draft Revisions to some DF/HCC S.O.P.'s will be posted today in the document library.

Study Team Members are encouraged to review the revisions and send any comments or concerns to cteo@dfci.harvard.edu.

S.O.P. Changes will go into effect on January 14, 2016.

Highlights of DF/HCC Standard Operating Policy Revisions
Effective: January 14, 2016

Please note that this is not a comprehensive list of all changes, but a summary of significant changes. In addition to the changes listed, all documents have been updated to define responsibilities of the Office of Data Quality (ODQ) and the Clinical Trials Research Informatics Office (CTRIO) and remove references to Quality Assurance for Clinical Trials (QACT).

Significant Revisions: Formal Training Required

CON-101:Informed Consent of Non-English Speakers

  • Section 5.1: The process for use of a fully-translated consent form has been updated throughout this section. Updates include changes to who will sign each document, and to clarify the process when the person obtaining consent is fluent in the subject’s language.
  • Section 5.2: This section has been updated to clarify the use of an Addendum along with the Short Form consent. 

MON-100:  Monitoring Phase I Dose Escalation for PI-Initiated Protocols

  • Significant changes have been made to this document to describe the process for Dose Escalation in trials that have Centralized registration (through ODQ) or De-Centralized Registration. 

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

  • Significant edits have been made to the document to clarify the process of IND submission and maintenance.
  • Section 5: Procedure has extensive modifications  

REGIST-100: Eligibility Checklist

  • Section 5.1: Specifies that “Any protocol that has eligibility criteria must have a DF/HCC eligibility checklist created using the DF/HCC eligibility checklist template.”
  • Section 5.2: Added to read “Eligibility Checklists are either created by the Lead site Study Team or the Office of Data Quality. Study team members should contact their Research Manager if they are unsure which process to follow.  The Office of Data Quality will maintain a record of which studies follow each process.”
  • Section 5.3: Completely re-written to describe the new process for study team eligibility checklist creation and maintenance.
  • Section 5.4: Updated to clarify the role of ODQ on trials where the checklist is centrally maintained by ODQ.

REGIST-101A: Centralized Subject Registration

  • This document describes the Centralized Subject Registration process and has been updated based on the previous REGIST-101.
  • Section 5: Procedure has been updated to reflect the role of ODQ in this process.

REGIST-101B: De-Centralized Subject Registration

  • This is a new SOP that describes the Decentralized Subject Registration process.

REGIST-102: Subject Removal from a Protocol

  • Extensive edits were made throughout this document in order to describe the process for taking a subject Off Treatment and Off Study under both the Centralized Subject registration process and the Decentralized Subject Registration Process.

REGIST-104: Using the Eligibility Checklist

  • This is a new SOP that describes the use of the eligibility checklist as part of the registration process.

Eligibility Checklist Template 

  • This new template was created to go along with changes to REGIST-100 and REGIST-104.

Other Revisions:

ADM-102: Maintenance of the Priority List on the Oncology Protocol System (OncPro)

  • Text has been edited to read; “Under the NCI Cancer Center Core Grant requirements, prioritization of protocols must be approved by the Scientific Review Committee (SRC). The SRC must also review changes to the Priority List.”
  • Additional Edits have been made to Section 5: Procedure, to describe the process clearly.

DATA-100: Data Management of PI-Initiated Protocols

  • Policy Statement now reads: “The Office of Data Quality (ODQ) and the Clinical Trials Research Informatics Office (CTRIO) are jointly responsible for managing clinical research data for PI-initiated therapeutic protocols”
  • Updates throughout the SOP to clarify the responsible party (CTRIO or ODQ) for tasks previously performed by QACT.

DATA-101: Case Report Form (CRF) Design for PI-Initiated Protocols

  • Updated to indicate that CRF builds will be the responsibility of CTRIO.
  • Minor edits throughout to clarify the CRF development process.
  • Many timelines have been edited or removed.

DOC-102: Note to File

  • Policy Statement: Added “Excessive use of Note to File is strongly discouraged.”
  • Sections 5.3 and 5.4: Clarification on the appropriate uses of Note to File.

EDU-100: Protocol Specific Training Requirements

  • Section 5.2.1 : Clarified that “Individuals not attending the SIV or added to the research team after the SIV must complete training prior to performing any research procedure.”

EDU-102: Human Subject Protection Training Requirements

  • Policy Statement has been edited to read:  “Investigators and research personnel who participate in the design, conduct or collection and reporting of data related to Human Subject Research overseen by DF/HCC must be trained in Human Subject Protection (HSP) Training prior to any involvement in human subject research or oversight of human subject research.  This includes research that is deemed Exempt under the regulations or is considered to be Not Human Subjects Research (NHSR).”
  • Significant edits have been made to this document to supplement Section 3: Responsible  Personnel; Section 5: Procedure; and Section 7: Related References

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

  • Section 4.10: Definition of Significant Risk has been added
  • Section 4.11: Definition of  Non Significant Risk has been added
  • Section 4.12: Definition of Investigational Device Exemption has been added
  • Section 5.2.3 has been edited to clarify the Sponsor Responsibilities for IDE Exempt studies

RCO-103: Confidentiality of Research Information

  • Section 5.1: Text has been added to clarify:  Research information is considered confidential and proprietary and is owned by the sponsor. As such, it cannot be released to any individual or party outside DF/HCC without permission of the sponsor.
  • Section 5.2: Added: Within DF/HCC, research information may be released only to those DF/HCC personnel involved in the study or who otherwise have a need to access it for purposes of the study. Release to any other DF/HCC personnel requires permission of the sponsor.
  • Section 5.3: Added: Research information, including data and protocols, may not be used for other research projects without the permission of the sponsor and the approval of the DFCI IRB. Sponsor approval must be submitted to the IRB with the new project application.

RCO-201: Completion of FDA Form 1572

  • Section 5.2.1 allows for limited exceptions to the policy of a single 1572 for DF/HCC.

RCO-202: Research Personnel CVs and Licenses

  • Content has been reorganized. Section 5.1 discusses CVs, and Section 5.2 discusses medical licenses.
  • Section 5.2 has been updated to clarify that valid licensure must be documented at time of study start-up and documentation must be maintained to demonstrate continuing licensure for the duration of one’s participation.
  • Section 5.2 has also been updated to note that Sponsors can be directed to the relevant Massachusetts state licensing websites in order to verify active medical licenses.

RCO-203: Managing Essential Regulatory Documents

  • Section 5.3.1.8: Financial Disclosure:  Text has been added “{Note: these documents are required only if the PI holds the IND or IDE}

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

  • Background Section has been edited to include references to regulatory requirements.
  • Section 4.6: Added definition of Research Activity.
  • Additional minor clarifications throughout the document.

REGIST-103: Transfer of Subjects Between Institutions

  • Policy Statement has been updated to better define subject transfers.
  • Text has been edited to clarify ‘Original institution’ and ‘Accepting institution’

REGIST-201: Posting Results and Adverse Events on ClinicalTrials.gov

  • Section 4.1: Updated to more clearly define Applicable Clinical Trials.
  • Section 4.3: Updated to more clearly define Primary Completion Date.

REGIST-300: National Cancer Institute Investigator Registration

  • Section 5.6 has been added to describe pharmacy contact information process

GUIDANCE ON DELEGATION OF TASKS

  • Text has been edited to clarify the role of Physician Assistants and Nurse Practitioners in assessing Adverse Events.

GUIDANCE ON INVESTIGATOR INTERACTIONS WITH MONITORS

  • Text has been removed that instructed the investigator to sign the monitoring report

DRUG DIARY TEMPLATE and GUIDANCE ON CREATING A DRUG DIARY

  • Updated Drug diary templates have been created by DF/HCC Nursing
  • 2016 Biomedical Engineering contact information has been updated for each institution

SPONSOR REGULATORY FILE CHECKLIST

  • Text has been added “(Note: Financial Disclosure for non DFHCC investigators are only required if the DFHCC overall PI holds the IND or IDE.)”

Administrative Changes Only:

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

ADM-101: Use of the DF/HCC Research Listserve

ADM-103: Maintenance of the AAHRPP Accreditation

AUD-100: Internal Auditing of Clinical Research

AUD-101: Audit Preparation and Response

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

COM-100:  Responsibilities of the Clinical Research Operations Committee

COM-101: Responsibilities of the Audit Committee

COM-102:  Accrual and Scientific Progress by the Scientific Review Committee

COM-103: Responsibilities of the Clinical Investigations Leadership Committee (CLC)

CON-102: Use of Healthy Volunteers

CON-103: Enrolling Subjects onto Secondary Studies Evaluating Research

DATA-102: Case Report Form Compliance for External Sponsors

DATA-103: Case Report Form Submission Compliance for PI-Initiated Protocols

DATA-104: Data and Safety Monitoring Committee (DSMC) Data Submission Compliance

DOC-100: Subject Research Charts

DOC-101: Source Documentation Requirements

EDU-101: Standard Operating Procedures Training Requirements

EDU-103: Good Clinical Practice Training Requirements

EDU-104: Audit Training for New Clinical Researchers

EDU-105: Training Requirements for new Overall Principal Investigators

MON-101: Routine Monitoring visits by External Sponsors

RCO-200: Documenting Delegation of Authority

RCO-206: Overall PI or Site Responsible Investigator Leave of Absence

RCL-100: Preparation for Site Close Out

REGIST-202: National Cancer Institute Clinical Trials Reporting Program (CTRP)

Guidance on Good Study Documentation Practices

Guidance: DFHCC Contacts for Clinicaltrials.gov accounts and Initial Registration

Guidance: How to Determine Primary and Study Completion Dates

Guidance: Guidance on Responding to Audit Findings

Guidance: Regulatory Binder Tool

Research Closeout Checklist

External Audit Contact List

List of Institutional IND Contacts