Guidelines
The Forms page has been provided to assist Investigators and Study Teams to procure services within the University setting. Forms must be completed in their entirety and forwarded to the respective departments. Please contact ocr@emory.edu with any issues with opening a form.
OCR Policies and Guidelines
- Compliance with Policy Requiring Use of Pharmacy Services to Manage Investigational Drug (PDF)
- IDS Drug Data Sheet
- Dispensing vs Delivery of Investigational Drugs (PDF)
- Investigational Drug Management for Clinical Studies
- New IDS Fee Schedule
- Guidance on Shipping Study Medication to Patients during Coronavirus Pandemic (COVID-19) (PDF)
- Packing Instructions (PDF)
- Conditioning Instructions (PDF)
- IDS SOP COVID19 Shipments - 05.24.2021 (PDF)
- Sepio 23-7L CRT (PDF)
- Sepio 23-7L Refrigerated (PDF)
- Clinical Research Accountability Matrix_Yr 2020 (DOCX)
- Clinical Research Role Matrix (Excel File)
- Standardization and Streamlining of OCR PRA Grid_Nov 2019
- New Reporting Structure: Unrealized Revenue_May 2019
- Improving Accuracy of PI initiated Studies Processed for the ClinicalTrials.gov Team Nov 2017
- Clinical Research Enrollment Metrics_Nov 2016
- Reducing Budget Shortfalls in Clinical Trials_Spring 2016
- Sponsor Naming Conventions_Nov 2015
- Consistency in OCR Budgeting Based on Historical Results 2014
- Results Reporting in ClinicalTrials.gov_Dec 2014
- Document Control of the Prospective Reimbursement Analysis (PRA)_Spring-2013
- Clinical Trials Determination for Investigators (PDF)
- Compliance Policy Requiring Coverage Analysis for New Clinical Trials (PDF)
- Mandatory Review Required for New Amendments to Clinical Research Studies Involving Research Participants (PDF)
- NIH Clinical Trial Definition (PDF)
- Non-Negotiable Budget Policy (PDF)
- OCR Decision Tree (PDF)
- OCR Waiver of Fees for Investigator-Initiated Clinical Trials (PDF)
In clinical research, remote/external patient monitoring uses digital technologies to monitor and capture patients' medical and other health data and electronically transmits this information to healthcare providers for assessment when necessary.
Your monitor will need access to Emory Healthcare's Medical Record System - Epic.
For Study Coordinators: You must complete the required forms for your monitor to gain access to Epic via the Emory Healthcare Link, which provides provision to review relevant patient information. See the Remote Monitoring workflow process.
- EHC Confidentiality and System Access Form
- Epic Link Access Request Form for Research/Study, Outside Auditors, and Other Record Review
For Study Monitors: After the Study Coordinator has asked for your access, Emory Healthcare will notify the Study Coordinator that entered the Link Access Request. The Study Coordinator will contact the Study Monitor to sign into Emory Healthcare Link.
Emory Healthcare Link is a secure, web-based portal (not an electronic medical record) that allows external healthcare entities (e.g., referring providers and study monitors) to view relevant patient information and perform service-oriented tasks (e.g., refer patients to Emory, enter orders). To close the loop at the end of patient care at Emory, referring providers will be sent messages containing a continuity of care document via Emory Healthcare Link.
- Login to Emory Healthcare Link
Resources or Tips Sheets
- Tip Sheet for Research New Account Request
- Tip Sheet for Study Monitors for Non-OnCore and Non-Epic Studies
For more information, please contact EHCLink.Admin@emoryhealthcare.org.
- Clinical Research Role Matrix
- EUSOM Principal Investigator Eligibility Policy
- Research Job Descriptions (for Coordinators, Research Nurses, etc.)
External Policies and Guidelines
- Clinical Research in EHC Facilities_9.11.2020 (DOCX)
- Integrating Clinical Care and Research: Things You Should Know
- Human Subjects Research Policy
- List of Access Coordinators (must be logged into Emory Healthcare Workspace to access and have an N number)
- Sensitive Studies Policy (coming soon)