Forms and Templates

OCR would like to acknowledge the support of the Winship Clinical Trials Office (CTO) and other institutions that provided resources and information.

Emory University: CT Feasibility Standard Operating Procedures (SOPs) and Forms

• Clinical Trial Feasibility Assessment Form
• Expanded Version Clinical Trial Feasibility Review Form
• Abbreviated Version Clinical Trial Feasibility Review Form
• Draft SOP Clinical Trial Feasibility 

Additional CT Feasibility Resources and Tools

• University of California San Francisco: Feasibility Analysis Guidance and Procedures
• Oregon Health and Science University/ Oregon Clinical and Translational Research Institute (OHSU): OHSU Templates and Resources, Protocol Development: Proposal Development and Protocol Feasibility Information, Oregon Protocol and Feasibility Analysis
• University of Alabama at Brimingham (UAB) Center for Clinical and Translational Science: Feasibility Analysis Guifance and Study Start-Up
• The Ohio State University Center for Clinical and Translational Sceince: Feasibility Analysis Guidance
• University of Winsconsin-Madison: Feasibility Analysis Guidance

Additional Standard Operating Procedures (SOPs) CT Trial and Protocol Feasibility Review

• Epworth SOP Feasibilities and Trial Start-Up
• OSU SOP Protocol Feasibility
• UHCMC SOP Clinical Research Protocol Feasibility Assessment
• USF SOP Study Feasibility

Sample CT Feasibility Assessment and Review Tools

• Credevo Feasibility Questionnaire Template
• Template Feasibility Checklist
• Comprehensive Feasibility Form
• Industry Sponsored or Initiated Drug or Device Protocol Feasibility Checklist
• Melbourne Health Protocol Feasibility Assessment Checklist
• Protocol Assessment Form 9.18.20
• Protocol Feasibility Review Form 3.19.21
• Protocol Intake Form 9.18.20
• RMH Clinical Trial Recruitment Predictor Tool
• SMPH Research Feasibility Checklist
• Template Site Assessment and Feasibility Questionnaire
• UCSF Clinical Trial Feasibility Checklist 

Clinical Trial Tools have been created in cooperation with the Institutional Review Board (IRB), Clinical Trials Audit and Compliance Office (CTAC) and the Emory's Office of Compliance (OC) for use by Investigators and their study teams involved in clinical trials. These are optional templates only. Please modify them to meet the needs of your department or trial. All forms can be found on the Clinical Trials Audit and Compliance website. Clinical Trial Tools.

The Georgia Clinical & Translational Science Alliance now offers studio consultations and resources that support investigators with the development of a Data and Safety Monitoring Plan and/or Board (DSMP/DSMB) that includes:

• NIH-guided DSMB charter template
• Request the DSMB registry of participating members 
• Charter outline template
• Emory IRB guidance document

Access the DSMB Service Request Form (consists of a Studio Consultation).

EML Grant Form

This form should be used ONLY when results should be EXCLUDED from posting to the subject’s Emory Healthcare medical record or they are non-Emory Healthcare patients or animals.

View EML Grant Form (RTF)

EML Non-Exempt Testing

This form should be used as a resource when determining labs that qualify as Non-Exempt Testing.

View EML Non-Exempt Testing (PDF)

EML Standard Description

This form describes all EML Standard Labs.

View EML Standard Description (PDF)

EML Checklist

This checklist provides instructions when submitting laboratory requests for research patients.

View the EML Checklist in the OCR CR eForm

EML Standard Lab Orders

This form should be used as a resource when determining EML Standard Lab Orders and CPT codes.

View EML Standard Lab Orders (PDF)

Study Participation

This form is used and must be submitted to OCR for subject reimbursement.

View Study Participation Form (PDF)

ACH Authorization

This form is used and must be submitted to OCR if the subject would like to be paid electronically. It is to be submitted via Emory Express.

View the ACH Authorization Form

OCR Travel Reimbursement

This spreadsheet will be used as a guide when submitting subject reimbursement information to OCR. DO NOT forget to send any receipts.

View OCR Travel Reimbursement Spreadsheet (Excel File)

Investigational Devices

The Grady Medical Device Study Indemnification Acknowledgement Form is available for download on the "General Forms & Agreements" webpage on the Emory OSP website.

• View OCR Submission Form in the Clinical Research eForm 
• View Study Team Effort Form
• View PI Certification of Seven Desirable Characteristics for Research Study (DOCX)
• PI Effort Calculation Form

Emory IRB Verbal Consent Template
The verbal template includes the details about the person obtaining consent and is used to upload in OnCore as an oral script.

Informed Consent Process Note
The informed consent process note could be used with the verbal consent form or as a consent waiver in OnCore.

MRN Request Form
Please allow 24 hours for this request to be completed. 

This form is only to be used for OnCore subjects with billable Emory Healthcare items or services but do not have an Emory Healthcare medical record number (MRN). 

If the subject needs an MRN and drug is also needed on the same day as the visit, IDS will issue the drug but would need the following:

• A prescription order sent to idsfax@emory.edu. 
• The study team would have to get the prescription created by IDS and from IDS, per the current process.
• Will need the last signature page of the signed consent.

There are four research forms used for Emory studies that require Radiology services. Please review the research forms below on the Department of Radiology and Imaging Sciences webpage.

Order for Research Study in Emory Radiology

This form is used for ordering and scheduling imaging mandated by a research protocol for outpatients ONLY.

View Order for Research Study Form 

Emory University Radiology Checklist

This form is to be completed Pre-award for any study with protocol-mandated Radiology procedures.

View Emory University Radiology Checklist in the CT PreStudy eForm App

Order for Research Study in Emory Radiology that include Biopsies

This form is for any research study involving IMAGE-GUIDED BIOPSIES. If imaging alone is to be performed, please use the required Imaging Form.

View Order for Research Study in Emory That Include Biopsies Form

Request for Pre-Clinical (Phantom) Imaging

This form should be submitted to request Pre-Trial Imaging.

View Request for Pre-clinical Imaging Form

This form provides qualifying criteria for protocol submission to the Rapid Response Team and the documents required to complete the submission process.

• View the Rapid Response Team Service Request Form and Submission Instructions.

However, the Georgia Clinical & Translational Science Alliance (Georgia CTSA) Trial Innovation Center's Navigator Team facilitates the flow of clinical research trials from concept to initial approval and implementation by assisting with maintaining compliance, quality, and innovation activities for each of the research offices at Emory University, Morehouse School of Medicine, University of Georgia, and other partner institutions of the Georgia CTSA. Review their website at https://georgiactsa.org/research/regulatory-knowledge-support/ltics.html.