DOCR Policies and Procedures

Annual Performance Evaluation of Clinical Research Personnel (12/04/2023) - This policy provides the standards for CRUs as it relates to the direct reporting requirements of Clinical Research Coordinators (CRCs) and research personnel performing the CRC role to the Research Practice Manager (RPM).

• Memo from Dean Andrews on the organizational minimum standards for Clinical Research Units (CRUs)
• Performance Evaluation and Planning (PEP) Form

Clinical Research Unit (CRU) Creation (06/01/2023) - This policy describes the process of Clinical Research Unit (CRU) creation.

Clinical Research Unit (CRU) Dissolution (06/01/2023) - This policy describes the process of dissolving a Clinical Research Unit (CRU).

Clinical Research Unit Structure and Organization (02/21/2023) - This policy provides an overview for the structure and organization of clinical research for Duke Medicine (defined as the integration of Duke University Health System, Duke School of Medicine, and Duke School of Nursing).

• CRU Charter Template (05/12/2021)--This document provides a template that CRUs can use when drafting a charter
• CRU Director Sample Job Description (04/07/2022) - This document provides a sample job description for a CRU Director

CRU/Oversight Organization Change Request Policy (07/05/2024) - This policy provides an outline for the process of changing a study to another CRU.

Scientific Review of New Clinical Research Proposals (07/15/2024) - This policy outlines the standards of Clinical Research Unit (CRU) review of new clinical research proposals.

Scope of Oversight and Responsibility of Clinical Research (02/22/2024) - This policy defines the scope of clinical research that is managed through Clinical Research Units and the responsibilities each CRU has for oversight of those projects.

Baccalaureate of Nursing for Research Staff (07/03/2024) - In order to advance the educational level of clinical research nurse coordinator (CRNC) and clinical research nurse coordinator, senior (CRNC, Sr.) registered nurses working in the Schools of Medicine and Nursing, a policy has been instituted requiring employees in these classifications have a baccalaureate degree. This policy is aligned with the DUHS strategy that has already been implemented. Please open the file to read the entire policy.

Clinical Trials Disclosure (10/05/2023) - This policy establishes internal institutional requirements to comply with federal regulations on clinical trial disclosure set forth in FDAMA and FDAAA.

Coverage Analysis (CA) and Payment of Copayments & Deductibles (05/08/2023) - This policy defines the Coverage Analysis (CA) procedure and acceptance of sponsor payments for procedures/services.

Duke Office of Clinical Research (DOCR) Effort Allocation Policy (08/02/2023) - This is the policy for allocating effort for DOCR staff.

Hosting Youths in Clinical Research (09/26/2024) - This policy defines the requirements for hosting youths in clinical research and the allowable activities for youths.

Institutional Approval:  New Clinical Research Study Initiation, Review, and Approval Standards (10/03/2023) - This policy describes the role of DOCR in the study approval process and outlines the steps necessary to obtain DOCR approval on a project.

Internal Cost Assessment (05/28/2024) - The purpose of this policy is to outline the process and requirements for developing an internal cost assessment (a determination of projected actual study costs) and what approvals are required.

• One Duke Budget (ODB) Workbook Instructions
• One Duke Budget (ODB) Workbook Template with Milestone Visits

Payment Terms and Budget Policy (08/26/2022) - This policy outlines roles and responsibilities regarding payment terms and sponsor budget attachments in clinical research agreements.

Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel (11/20/2023) - The purpose of this policy is to outline the process for adding Duke students, unpaid volunteers, and visiting trainees/interns to study personnel.

Routine Costs in a Clinical Trial: NC Medicaid (10/24/2023) - This policy defines routine and qualifying trials for NC Division of Medical Assistance and describes when routine cost in a clinical trial may be charged to NC Medicaid/NC Health Choice.

Study Eligibility Documentation (06/03/2024) - This policy provides investigators and research teams with best practices for creating eligibility source documentation for interventional clinical research studies open to accrual.

Distribution of Policies and Procedures External to Duke Medicine (10/17/2023) - This policy provides guidance to staff when an external organization or non-Duke employee has requested a DUH/DUHS/SoM policy or procedure.

Duke Box for Clinical Research Study Monitoring (03/13/2023) - This SOP clarifies the use of Duke Box when remote monitor visits are requested.

Escalation Process for Resolution of Research Charge Reversal (01/08/2024) - This policy defines the process that research staff are required to follow when the usual reversal process for clinical research procedures billed to a participant's insurance is not resolved.

FDA and External Regulatory Agency Audits and Inspections (09/03/2024) - This policy defines Duke Medicine expectations related to audits and inspections whether they are for cause or routine.

• Sample FDA Audit Checklist

Guidance for Clinical Research Involving Participants Currently or Previously Infected with COVID19 (03/01/2023) - This document provides general guidance for clinical research study teams that may be physically interacting with or collecting biospecimens from research participants that have been infected with or considered a Person Under Investigation (PUI) for SARS-CoV-2 (COVID-19).

Investigational Study Drug Dispensing under PI Oversight at Duke Affiliated Clinical Research Site (01/12/2023) - This policy sets forth the requirements to assure proper receipt, handling, storage, dispensing, and disposition of Investigational Study Drugs (ISD) for PI-Initiated and externally sponsored clinical research studies at Duke clinical research sites.  It also aims to ensure the integrity and associated study data in accordance with all federal, state and institutional regulations as well as any protocol-specific guidelines/requirements.

• TEMPLATE:  Investigational Study Drug Dispensing under PI Oversight Standard Operating Procedure

IRB Expiration Monitoring (12/05/2023) - This policy outlines the process of monitoring IRB protocols for expiration and details the steps required in the event of a protocol approval lapse.

Onsite and Remote Access for Monitor andor Auditor Visits (02/25/2022) - This policy describes the process by which Duke Health facilitates onsite and remote access for all research monitors/auditors regardless of whether or not access to electronic medical records of participants on a research protocol is needed.  When a monitor needs remote access to electronic medical records, please follow the policy on Requesting and Granting Remote Monitor Access to Maestro Care.

• Confidentiality Agreement for Research Monitors/Auditors

On Call for Exempt Clinical Research Staff (06/01/2023) - This document standardizes the process for tracking and compensation of clinical research coordinators who provide on call support for research activities.

• CRC On Call Tracking Template

Oversight of Equipment Utilized in Research Studies (03/14/2024) - The purpose of this policy is to outline the policies and procedures in place to assure that equipment utilized to carry out research activities is maintained per manufacturer’s specifications.

Process for Requesting PACE Access for CQMP Reviewers (02/19/2024) - This document describes the process for requesting temporary view-only PACE access for Clinical Quality Management Program (CQMP) reviewers.

Requesting and Granting Remote Monitor Access to Maestro Care (03/16/2023) - This policy describes the process for requesting and granting remote access to medical records for research monitors when access is supported through an IRB-approved research protocol.

Research Requirements for DUHS Nursing Services for DEPRU and Duke Research at Pickett (R@P) (12/08/2023) - This policy describes how Duke University Health System (DUHS) nursing staff and unlicensed authorized providers (UAPs) will be managed with regard to key personnel and delegation of authority for studies done in the Duke Early Phase Research Unit (DEPRU) and Duke Research at Pickett (R@P)

• Blanket Delegation of Authority for DUHS Nursing Services for DEPRU and Duke Research at Pickett (R@P) (08/27/2024) - The purpose of this document is to describe the Blanket Delegation of Authority, which allows the PI to delegate nursing activities to DUHS nurses and UAPs providing care to research participants as referenced in the Research Requirements for DUHS Nursing Services for DEPRU and Duke Research at Pickett (R@P)

Students/Residents/Fellows Leaving Duke Requiring Continued Access to Research Data (06/14/2024) - This policy outlines the process for students/residents/fellows leaving Duke requiring access to research data to support continued research activities.

Utilization of Zoom for Remote Research Visits (06/01/2023) - The purpose of this document is to provide guidance to Duke researchers and study teams on the use of video conferencing tools for Clinical Research.

Xealth for Research:  Delivering Digital Study Content to Duke Health Patients (02/15/2024) - This document offers general guidelines for Duke Investigators and research teams planning to use Xealth to send digital content about a research study to potentially eligible Duke Health patients in the pre-consent period.

Clinical Research Closeout Policy (02/07/2024) - This policy outlines the process and requirements for closing out a study and what approvals will be required prior to the completion of the financial closeout.

Closeout Tools: Clinical Research Tasklist (03/08/2022)

Study Closeout (02/26/2024) - This policy ensures that all research-related activities are completed and signed off prior to closing the clinical research study.

• Sample Closeout Checklist (06/24/2021)

Clinical Competency for Non-Licensed Research Study Personnel Performing Vital Signs  (02/16/2024) - This policy defines training requirements and skills necessary for non-licensed (NL) study personnel to perform clinical competencies limited to vital signs (blood pressure, pulse, temperature, pulse oximetry, respiration rate, body weight and height) for the purposes of collecting this information as required by clinical research protocols.

Related document:  Documents for CRC Vital Sign Competency

Clinical Research Nurse Coordinator (CRNC) Credentialing Policy (10/22/2024) - This policy defines credentialing and competency validation requirements necessary for licensed Clinical Research Nurse Coordinators (CRNCs) to perform clinical competencies as required by clinical research protocols and to describe communication requirements prior to conducting research in a clinical area.

Related documents:

• Guide for Determining Required Competencies for Clinical Research Nurse Personnel
• SOP for Nurse Credentialing Documentation in REDCap and Box
• CRNC Onboarding Learning Plan
• Research Nurse Competency Documentation REDCap
• Clinical Competency Validation Forms (Checkoffs) for Research – Box Folder
• Research Nurse Competency Documentation REDCap FAQs Tip Sheet
• CRNC Credentialing Checklist for Verification Purposes

Collaborative Institutional Training Initiative (CITI) Module Requirements for Duke Health Human Subject Protection (HSP) (12/18/2024) - This policy describes the Human Subject Protection (HSP) certification requirements for all Duke Health clinical research personnel who interact with study participants or who have access to study participant private information.

Pediatric Phlebotomy Competency Training for Approved Research Study Personnel (02/16/2024) - This policy defines the training requirements and skills necessary for approved research study personnel to perform venipuncture/phlebotomy for the purposes of collecting research blood samples from pediatric patients. This policy applies to approved research study personnel in one of the 12 clinical research professional job classifications.

Phlebotomy Competency Training for Research Study Personnel (02/16/2024) - This policy defines the training requirements and skills necessary to perform venipuncture/phlebotomy for the purposes of research in Duke Medicine.

Related documents:

• Duke Office of Clinical Research (DOCR) Phlebotomy Training to Draw Blood from Adult Research Participants (04/25/2022)

• Attestation for Phlebotomy Competency for Research Study Personnel (8/23/2023)

• Phlebotomy Renewal Form (10/19/2022)

Protocol Training for Clinical Research Professionals (05/06/2024) - This policy defines training requirements for clinical research personnel listed on the Delegation of Authority Log.  All clinical research personnel must complete training for all tasks that are delegated to them prior to performing the task.

Urine Testing for Pregnancy Screening to Determine Eligibility to Participate in Research Studies (02/26/2024)

Duke Protected Analytics Computing Environment (PACE) Transfer Agent Policy (07/21/2022) - Studies or projects using the Protected Analytics Computing Environment (PACE), can only remove files, results, code, or data from PACE through an approved Honest Broker or an approved project-specific Transfer Agent. The following defines the requirements for individuals acting as Transfer Agents for PACE projects at Duke.

• PACE User Attestation
• Protected Analytics Computing Environment (PACE) Access Agreement

REDCap Secure Usage Policy (02/28/2023) - This policy provides information about using the Research Electronic Data Capture (REDCap) system in a safe and secure manner.

Research Electronic Data Capture (REDCap) User Role Requests (10/28/2024) - This policy defines the roles and responsibilities of REDCap system users.

Sharing Data via Zenodo at Duke (11/18/2024) - This policy outlines the use of Zenodo for sharing data and other research artifacts at Duke.

Text Messages in Clinical Research at Duke (04/17/2024) - This policy defines the requirements for text messaging as it relates to clinical research at Duke.

Use of VA Data for Research at Duke (03/07/2024) - The VA has specific data requirements for research data requests involving the use of VA data outside of the secure VA environment, when a HIPAA authorization has not been obtained. To meet VA data security requirements, Duke will maintain VA data within a FISMA moderate environment. A summary of the requirements and data solutions that Duke has implemented are found in this policy.

Use of Honest Brokers for Clinical Research at Duke (10/17/2023) - This policy defines the requirements for individuals performing roles as Honest Brokers for research involving Duke Health data.

Tools

Where Can My Research Data Go? (11/3/2023) This flowchart will help you answer questions about where you can store your research data.

Documenting Clinical Research Data in Epic – a Guide for Staff in Clinical Research Professional Job Titles (02/28/2024) - This policy provides information regarding the appropriate place for Clinical Research Professional (CRP) staff to document clinical research information in Epic / Maestro Care.

Maestro Care For Research (03/05/2024) - This policy defines the process for submission of requests for builds and/or support in Maestro Care (MC).

Placing Informed Consent Forms and Consent Process Notes in Maestro Care (05/20/2024) - This policy outlines when placement of the informed consent form and consent process note are required in MaestroCare.

Preconsent Documentation in Maestro Care (11/13/2024) - This policy describes the process for using a preconsent status in Maestro Care.

Requirements for Maestro Care Access for Research Purposes (10/21/2024) - This policy defines eligibility and training requirements for Maestro Care (MC) access on a research template, and identify staff who may request research MC access for eligible end users.

Verbal Orders Policy (2/5/2020) - This Duke Health policy describes the process for verbal orders placed in Maestro Care.

Advarra eRegulatory (eReg) Binder Activation (09/23/2024) - This procedure oulines the necessary steps to activate an electronic regulatory binder in the Advarra eRegulatory Management System (eReg).

Consent Category Requirements in iRIS and OnCore (03/04/2024) - This policy defines the requirements of Informed Consent form information needed in iRIS to ensure all IRB approved submission details transmit from iRIS to OnCore successfully.

Emailing Documents to an eReg Binder (08/02/2024) - This policy defines the requirements for using the email functionality in the Advarra eRegulatory Management System (eReg).

eReg Review Session (Remote Monitoring) Policy (06/23/2023) - This policy defines guidelines for using the Advarra eRegulatory (eReg) system for remote monitoring.

​​OnCore Documentation for Clinical Research Participants (07/01/2023) - This policy defines the requirements for documenting study participation in OnCore for participants who consent to clinical research protocols approved by the DUHS IRB.  Note that this policy does not apply to retrospective reviews, exempt studies, or studies using the summary accrual function in OnCore.

OnCore Minimum Footprint Report Requirements and Purpose (10/03/2023) - This policy defines the purpose of, and requirements for, the Minimum Footprint Protocol Detail Report in the OnCore application for new and modified research protocols.

Protocol Status Update Requirements in OnCore (01/04/2024) - This policy defines the requirements for updating the protocol status in OnCore.

Use of Subject Binders in Advarra eRegulatory (eReg) (10/27/2023) - This policy defines guidelines for using the Subject binder functionality of Advarra eReg.

All Pickett Road Policies and Supporting Documents can be accessed here.

Care Everywhere Use for Research Nurses (12/12/2024) - This policy defines Care Everywhere access and its use for Research Nurses’ coordination of care of patients participating in therapeutic clinical research protocols

• Care Everywhere and Research White Paper(12/12/2024)
• Rules of the Road for the Care Everywhere Network (12/12/2024)

Designation and Responsibilities of the SPOC (12/12/2024) - This policy identifies the RPM as the SPOC (single point of contact)  for Tier Advancement and describe the duties that the SPOC is responsible for. If SPOC duties are delegated, to describe the process and necessary actions that must take place

Eligibility of Tier Advancement for Clinical Research Professional Staff (09/13/2024) - This policy defines eligibility criteria for clinical research professional staff members who apply for Tier Advancement.

**As of January 2024, Duke ClinCard pricing is $4.00 per ClinCard and $1.75 to load the ClinCard.**

Social Security Number Exception Request Waiver for ClinCard (03/06/2024) - This policy outlines  the  process  for Social  Security  Number  (SSN) Exception  Request  waiver in  the Enterprise  Governance,  Risk and  Compliance  website  (eGRC) for Duke  ClinCard. The  Duke ClinCard  system  is  a  reloadable  debit  card  which  can  be  used  to  pay  participants  for  their participation in clinical research.

• Template:  Procedure for Using the Duke ClinCard System (11/14/2023) - This SOP Template outlines the process for using the Duke ClinCard System within a department and identifies the staff responsible for performing the roles.

Uploading a Receipt in the Duke ClinCard System QRG

Study Coordinator/CRC QRG

Approver QRG