DOCR Policies and Procedures

DOCR policies are posted behind the Duke firewall and only accessible after providing a username and password and/or logging in through VPN.   If you are Duke personnel and are unable to access one of these documents, please send an email to docr.help@dm.duke.edu for assistance.

DOCR Definitions (11/14/2018) - This policy defines the terms used in the clinical research policies and procedures developed by the Duke Office of Clinical Research (DOCR).

Clinical Research Unit (CRU) Policies

Annual Performance Evaluation of Clinical Research Personnel (9/13/2019) - 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).

Baccalaureate of Nursing for Research Staff (6/28/2018) - 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 Research Unit (CRU) Creation (3/10/2017) - This policy describes the process of Clinical Research Unit (CRU) creation.

Clinical Research Unit (CRU) Dissolution (3/10/2017) - This policy describes the process of dissolving a Clinical Research Unit (CRU).

Clinical Research Unit Structure and Organization (3/29/2018) - 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/Oversight Organization Change Request Policy (12/07/2018) - This policy provides an outline for the process of changing a study to another CRU.

Scientific Review of New Clinical Research Proposals (1/2/2019) - This policy outlines the standards of Clinical Research Unit (CRU) review of new clinical research proposals.

Scope of Oversight and Responsibility of Clinical Research (1/2/2019) - 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.

Study Start-Up Policies

Clinical Trials Disclosure (1/21/2019) - 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 (10/1/2019) - 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 (1/18/2019) - This is the policy for allocating effort for DOCR staff.

Internal Cost Assessment (11/9/2018) - This policy outlines the process and requirements for developing an internal cost summary (determination of projected actual study costs) and what approvals will be required.

New Clinical Research Study Initiation, Review, and Approval Standards (11/14/2018) - This policy describes the role of DOCR in the study approval process and outlines the steps necessary to obtain DOCR approval on a project.

Payment Terms & Budget Policy (11/09/2018) - This policy outlines roles and responsibilities regarding payment terms and sponsor budget attachments in clinical research agreements.

Routine Costs in a Clinical Trial: NC Medicaid (3/10/2017) - 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.

Ongoing Study Management Policies

CMS Billing Regulation Regarding Healthy Volunteers - This document describes the CMS regulations regarding billing for healthy volunteers on clinical research studies.

Distribution of Policies, Procedures and Forms External to Duke Medicine (12/12/2018) - This policy provides guidance to staff when an external organization or non-Duke employee has requested a DUH/DUHS/SoM policy, procedure and/or form.

Enrollment Quality Assurance in Maestro Care for Clinical Research Studies (3/8/2017) - This policy describes the process that DOCR uses to review the enrollment entries in Maestro Care to ensure that all DUHS subjects enrolled for clinical research studies have been entered accurately with the required documentation.

Escalation Process for Resolution of Research Charge Reversal (7/28/2017) - 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 (3/3/2017) - This policy defines Duke Medicine expectations related to audits and inspections whether they are for cause or routine.

IRB Expiration Monitoring (3/5/2017) - This policy outlines the process of monitoring IRB protocols for expiration and details the steps required in the event of a protocol approval lapse.

Monitor/Auditor Access to Maestro Care (3/15/2019) - This policy describes the process by which Duke Health facilitates remote and onsite access for research monitors/auditors when access to medical records of participants on a research protocol is needed.

On Call for Exempt Clinical Research Staff (9/11/2019) - This document standardizes the process for tracking and compensation of clinical research coordinators who provide on call support for research activities.

OnCore Minimum Footprint Report Requirements and Purpose (6/12/2019) - 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.

Participant Status and Study Visit Documentation in OnCore (9/6/2019) - This policy outlines the requirements for tracking participant visits in OnCore.

Policy on Retention, Preservation and Destruction of Records - This policy describes the proper way to retain records and samples obtained during research studies at Duke.

Registration of Clinical Research Participants Who Provide Informed Consent (12/07/2018) - This policy outlines the process for registration of Participants on clinical trials in OnCore.

Remote Monitor Access to Maestro Care (3/12/2019) - 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.

Social Security Number Exception Request Waiver for ClinCard (11/09/2018) - 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.

  • Procedure for Using the Duke ClinCard System (11/19/2018) - This SOP Template outlines the process for using the Duke ClinCard System within a department and identifies the staff responsible for performing the roles.

Study Close-Out Policies

Clinical Research Closeout Policy (11/14/2018) - 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 (11/13/2017)

Study Closeout (9/3/2019) - This policy ensures that all research-related activities are completed and signed off prior to closing the clinical research study.

Training Policies

Collaborative Institutional Training Initiative (CITI) Module Requirements for Duke Health Human Subject Protection (HSP) (11/30/2018) - 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.

Phlebotomy Competency Training for Research Study Personnel (11/13/2018) - This policy defines the training requirements and skills necessary to perform venipuncture/phlebotomy for the purposes of research in Duke Medicine.

Policy Statement Regarding Pregnancy Testing (6/5/2014) - This policy describes the DUHS IRB policy on pregnancy testing for females of child-bearing potential who are being considered for participation in a research study.

Urine Testing for Pregnancy Screening to Determine Eligibility to Participate in Research Studies (11/11/2018)

Data Policies

Duke Protected Analytics Computing Environment (PACE) Transfer Agent Policy (7/12/2018)

PACE User Attestation (1/9/2018)

Protected Analytics Computing Environment (PACE) Access Agreement (10/1/2017)

REDCap Secure Usage Policy (11/14/2018) - 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 (11/16/2018) - This policy defines the roles and responsibilities of REDCap system users.

Maestro Care Policies

Maestro Care For Research (1/25/2019) - 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 (06/21/2019) - This policy outlines when placement of the informed consent form and consent process note are required in MaestroCare.

Preconsent Documentation in Maestro Care (8/20/2019) - This policy describes the process for using a preconsent status in Maestro Care.

Care Everywhere Policies

Care Everywhere and Research (9/1/2018)

Care Everywhere Use for Research Nurses (7/19/2019) - This policy defines Care Everywhere access and its se for Oncology Research Nurses' coordination of care of patients participating in therapeutic clinical research protocols.

Rules of the Road for the Care Everywhere Network (9/1/2018)

Workforce Engagement and Resilience Policies

Designation and Responsibilities of the SPOC (2/27/2019) - 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 (2/21/2019) - This policy defines eligibility criteria for clinical research professional staff members who apply for Tier Advancement.

 

DOCR Procedures

DOCR provides the following procedural documents as resource for Clinical Research Units (CRUs):

Consenting for Research Studies Approved by the DUHS IRB (8/20/2019)

Exposure Risk Determination Sheet (10/27/2017)

Industry-Funded, Internally-Contracted Clinical Research Activities with No Measurable Effort  (Secondary Studies) (2/1/2019)

 

Forms and Checklists

Regulatory Binder Checklist

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