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
For assistance in creating a Data Safety Monitoring Plan (DSMP) or Data Safety Monitoring Board (DSMB), review the guidelines or templates below:
- Data Safety Monitoring Service Request Form- submit this request and complete the questionnaire, attaching the required documents.
- DSMB-DSMP Guidance, v2024
- NIH DSMB_Charter_Template, v2019
- DSMB Charter Outline_Template, v2019
View more information on the GaCTSA webpage at https://georgiactsa.org/research/regulatory-knowledge-support/ltics.html.
- 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
- 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 study monitor will need access to the subject's information in Emory Healthcare's Epic Medical Record System via EpicCare Link. View the Epic Study Monitor Access Workflow.
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
View the OnCore Sharepoint site> Study Monitors for EpicCare Link access for approvers, study coordinators, and study monitors.
- Emory University Standard Research Study Fees Memo (PDF) - 18JUL2022
The fee schedule and other financial information contained on this website are sensitive, proprietary, and confidential information that is not to be used except for the express purpose of budget development for Emory research studies and shall not be shared with any unauthorized person employed by Emory University or Emory Healthcare and not with any third party whatsoever. - Radiology Research Fees Letter (PDF)
- University Standard Research Study Fee Memo (7.18.2022)
Please note that these are both protected documents; if your browser does not prompt Single Sign On when attempting to open the documents, please try a different browser or clear your cookies, and the document should be accessible.
- Clinical Research Role Matrix
- EUSOM Principal Investigator Eligibility Policy
- Research Job Descriptions (for Coordinators, Research Nurses, etc.)
- Clinical Research Training Requirements for Emory and Emory Affiliates.
- Clinical Research Orientation and Training Executive Summary, V12,3.10.2025.
- Students in SOM Labs/Research
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)
- Emory University Standard Research Study Fees Memo (PDF) - 18JUL2022
The fee schedule and other financial information contained on this website are sensitive, proprietary, and confidential information that is not to be used except for the express purpose of budget development for Emory research studies and shall not be shared with any unauthorized person employed by Emory University or Emory Healthcare and not with any third party whatsoever. - Radiology Research Fees Letter (PDF)
- University Standard Research Study Fee Memo (7.18.2022)
Please note that these are both protected documents; if your browser does not prompt Single Sign On when attempting to open the documents, please try a different browser or clear your cookies, and the document should be accessible.
- Sensitive Studies Policy (coming soon)