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 (3/30/2018) - 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 (12-6-2016) - 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 Research Policy (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 Change Request Policy (3/10/2017) - This policy provides an outline for the process of changing a study to another CRU.

Scientific Review of New Clinical Research Proposals (3/10/2017) - This policy outlines the standards of Clinical Research Unit (CRU) review of new clinical research proposals.

Scope of Oversight and Responsibility of Clinical Research (3/29/2018) - 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.

  • Additional document(s) to this policy: Fee Schedule (posted: 05/01/2010)

Study Start-Up Policies

Clinical Trials Disclosure (01/18/2017) - This policy establishes internal institutional requirements to comply with federal regulations on clinical trial disclosure set forth in FDAMA and FDAAA.

DUHS Clinical Research Institutional Approval: Waiver Requests (3/10/2017) - This policy describes when a waiver of the institutional policy governing full institutional approval of clinical research protocols may be requested.

Internal Cost Assessment (3/13/2017) - 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 (3/10/2017) - 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 Attachment Policy (3/13/2017) - 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

Monitor Audit Access to Maestro Care (3/28/2018) - 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.

eGRC Policy for ClinCard (3/2/2017)

Duke ClinCard SOP Template

On Call Tracking Policy (8/23/2017) - 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

CMS Billing Regulation for 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 (2/1/2017) - 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.

DOCR 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.

DUHS 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.

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.

Monitoring Continuous Reviews to Avoid IRB Expirations (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.

Participant Status and Study Visit Documentation in OnCore (5/21/2018) - This policy outlines the requirements for tracking participant visits in OnCore.

Quality Assurance Monitoring Review Standards for Clinical Research (9/18/2017) - This policy defines the minimum standards for Clinical Research Unit (CRU) internal Quality Assurance (QA) monitoring reviews of clinical research studies where Duke is a site.

REDCap Secure Usage Policy (8/25/2016) - This policy provides information about using the Research Electronic Data Capture (REDCap) system in a safe and secure manner.

REDCap User Role Requests (2/21/2017) - This policy defines the roles and responsibilities of REDCap system users.

Registration of Participants Who Provide Consent (5/21/2018) - This policy outlines the process for registration of Participants on clinical trials in OnCore.

Study Close-Out Policies

Clinical Research Closeout Policy (11/1/2016) - 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.

Study Closeout Task List (11/13/2017)

Duke Policies and Guidelines for Disposition of Human Biological Samples and Associated Data when a Faculty Member Leaves Duke (Biobank, 4-14-2015)

Training Policies

Collaborative Institutional Training Initiative (CITI) Module Requirements for Duke Health Human Subject Protection (HSP) (10/12/2017) - 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 (02/09/2016) - 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.

Maestro Care Optimization Policies

Maestro Care Support Request Submission Policy (3/9/2017) - This policy defines the process for submission and review of new proposals for optimization in Maestro Care.

Care Everywhere Policies

Care Everywhere Use for Oncology Research Nurses (2/1/2017) - This policy defines Care Everywhere access and its se for Oncology Research Nurses' coordination of care of patients participating in therapeutic clinical research protocols.

 

DOCR Procedures

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

Department of Surgery Guidelines for Informed Consent for Research Prior to Surgical Intervention (8/9/2013)

Distribution of Policies, Procedures and Forms External to Duke University Hospital (DUH), Duke University Health System (DUHS) and Duke School of Medicine (SoM) (12/3/2014)

Exposure Risk Determination Sheet (10/26/2015)

Industry-Funded, Internally-Contracted Clinical Research Activities with No Measurable Effort  (Secondary Studies) (12/12/2017)

Studies Without Institutional Approval and Preset Expiration Date in the eIRB (9/9/2014)

Requesting and Terminating Velos eResearch User Accounts (1/1/2013)

Urine Testing for Pregnancy Screening to Determine Eligibility to Participate in Research Studies (1/14/2013)

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