Research Administration


Research Administration provides the infrastructure for pre- and post-award management of sponsored research projects. This includes proposal submission, budget preparation, routing documents for appropriate internal approvals, and ongoing fiscal management over the duration of the award.

The process varies and depends on many different factors: your institution affiliation, type of research conducted and location where research activities will occur.


Click below to see Your Research Pre-award Pathway:


Ready to get started?

For Emory Department of Pediatrics Faculty, complete the Intent to Submit Form.

For Children's PIs and Emory Faculty* outside of Department of Pediatrics, complete this form.

*please also contact your ORA (Children's) at ResearchAdministration@choa.org or RAS (Emory) pre-award analyst.  RAS Pre-Award Analyst can be found under Portfolio Assignments or the Peds RAS webpage.


If your research involves a Confidentiality Agreement (CDA) or Non-Disclosure Agreement (CDA), please utilize below guidance to determine how to route your CDA/NDA:

Confidential Disclosure Agreements, sometimes referred to as an NDA (Non-Disclosure Agreement) or an RDA (Restricted Disclosure Agreement). Generally speaking these types of agreements outline what information is confidential, what and how information can be shared, and what information should be restricted from other parties. These agreements allow parties to discuss details of their business and inventions without the fear of making important information public. 

For new confidential disclosure agreements (CDA) and non-disclosure agreements (NDA), approval is required by the appropriate office.  Please review the list below to determine which category best fits the purpose of the new CDA or NDA.  When you send an email, please remember to list the Emory PI for the CDA along with the Sponsor’s name and email contact to return the executed CDA.

Where to route CDAs/NDAs

CDAs for Industry/Clinical Trials

​For industry clinical trials with a Children’s component (most will fit this), route to Children’s Office of Research Adminsitration

 ►Process: Send email with the CDA attached to Children's Office of Research Administration.

For industry clinical trials without a Children’s component, route to Emory Office of Sponsored Programs (OSP) 

 ►Process:   Any confidentiality agreements received from a third party pertaining to clinical research (trial or study)should be routed to Office of Sponsored Programs/OSP for review and signature at the following email address: OSP-CONTRACTS@LISTSERV.CC.EMORY.EDU.

Please ensure the following information is provided at the time of submission to the OSP listserv: 

  • Principal Investigator
  • Sponsor Contact Name
  • Sponsor Contact Email Address
  • Project Title
  • Proposed or draft agreement (attached in Word format only (not pdf) in case edits are needed)
  • Clearly identify any request that is urgent and require expedited review in subject heading
  • Information about data sharing:
    • Emory will receive confidential information only; OR
    • Emory will share confidential information only; OR
    • Sponsor will share confidential information and Emory will or may share confidential information

If a sponsor or other third party does not have a template or draft CDA/NDA agreement, Emory’s CDA/NDA template can be provided as the proposed draft agreement.

CDAs for Foundations/Non-Profits and Federally funded trials 

Route to Emory Office of Sponsored Programs (OSP)

►Process:   Any confidentiality agreements received from a third party pertaining to clinical research (trial or study)should be routed to Office of Sponsored Programs/OSP for review and signature at the following email address: OSP-CONTRACTS@LISTSERV.CC.EMORY.EDU.

Please ensure the following information is provided at the time of submission to the OSP listserv: 

  • Principal Investigator
  • Sponsor Contact Name
  • Sponsor Contact Email Address
  • Project Title
  • Proposed or draft agreement (attached in Word format only (not pdf) in case edits are needed)
  • Clearly identify any request that is urgent and require expedited review in subject heading
  • Information about data sharing:
    • Emory will receive confidential information only; OR
    • Emory will share confidential information only; OR
    • Sponsor will share confidential information and Emory will or may share confidential information

If a sponsor or other third party does not have a template or draft CDA/NDA agreement, Emory’s CDA/NDA template can be provided as the proposed draft agreement.

CDAs for Pre-Clinical Studies or anticipation/discussion of potential research

 Route to Office of Technology Transfer (OTT) - including investigator-initiated studies
►Process:

Incoming Data Transfer/Use Agreements (DTA/DUAs): Skip the paper forms and use the form found on Emory contractConnect. The system will collect all of the pertinent information. The system requires a valid Emory netid. Send correspondence to ott-mta@emory.edu.

Outgoing Data Transfer/Use Agreements (DTA/DUAs): Skip the paper forms and use the form found on Emory contractConnect. The system will collect all of the pertinent information. The system requires a valid Emory netid. Send correspondence to ott-mta@emory.edu.

Bi-lateral (reciprocal) Data Transfer/Use Agreements (DTA/DUAs): Skip the paper forms and use the form found on Emory contractConnect. The system will collect all of the pertinent information. The system requires a valid Emory netid. Send correspondence to ott-mta@emory.edu.

CDAs for Consulting Agreements

These need review by your Department and the Dean's office as an external activity
       ►Process: Submit the agreement as an external activity request in the Emory Electronic Conflict of Interest site
                    - You can view the eCOI submission instructions here. 

*If the CDA or NDA does not appear to fit the above categories, contact Sarah Marie Huban.

Additional Information

Definitions


Clinical Trial: Research study on human subjects involving some type of intervention (drug, device, treatment methodology) that generates safety and efficacy data. Click here for full NIH definition.
For trials involving drugs, the FDA has defined Phases based on the stage of the study in the development process.


Clinical Research: Research study on human subjects NOT involving intervention (usually minimal or no direct patient contact), including observational studies, basic data or specimen collections, and retrospective studies.


Pre-Award Considerations


Coverage Analysis (CA)/Prospective Reimbursement Analysis (PRA): Anytime a patient is seen in a clinical setting for a research study, a Coverage Analysis (CA) or Prospective Reimbursement Analysis (PRA) must be done to ensure that activities performed exclusively for the purpose of research are not charged to the patient or their insurance company.

PI Effort: Emory University School of Medicine has a policy requiring Investigators to commit a minimum of 1% effort to a clinical trial. Please note for Industry sponsors, effort is paid as a “fee” and is divided out per patient, per visit. This fee will only be paid as patients are enrolled and visits are completed.

Negotiations: Budget and contract negotiations are carried out by the institution on behalf of the PI. Each institution has specific fee schedules, terms and conditions set up to protect all parties involved. Please follow Your Research Pre-Award Pathway to understand which offices will be involved in your negotiations.

Contract Research Organization (CRO): Many industry sponsors outsource research operations to a CRO. If involved, they are usually the main contact for the study and perform many of the administrative functions on behalf of the sponsor. Examples of CROs: Quintiles, Parexel, Medpace, PPD, inVentiv.


Typical Components of a Clinical Trial budget


Per patient/patient care budget – an itemized list of services with associated costs needed for each subject in order to carry out the research protocol. Payment is usually made after subjects have been enrolled and the activities occur. Examples:

  • Physical exam/clinic visit
  • Radiology (x-ray, MRI, CT scan)
  • Procedures (biopsy, surgery, transplant)
  • Labs processed through the clinics or hospitals (CBCs, CP comp)
  • Pharmacy
  • Fees for PI and research staff time and effort

Administrative Fees – required for the general administrative set up and ongoing administrative needs to run the protocol. These are paid regardless of enrollment. Examples:

  • Start Up Fee: Paid at contract execution to reimburse staff for effort put forth to get the study open. This can also be used for supplies if needed.
  • IRB fee: Emory SOM assesses IRB fees for industry sponsored studies, charged only if the contract is executed. We may include additional fees for the effort involved with the regulatory process.
  • Document storage (varies): Charge for keeping all study documents in long term storage.
  • Pharmacy fees (could be either on the CHOA or Emory side, prices vary by site): For set up, drug receipt, inventory monitoring, storage, and closeout.

Pass Through/Invoiceable Items – these are conditional items, paid as needed or if the circumstance arises. Examples:

  • Additional patient care (labs, scans, procedures and associated effort): usually for “repeats” that are not applicable to every patient, example: if WBC result is below 200, repeat within 24 hours.
  • Audits/Monitor visits: time and effort for study staff preparing for visits.
  • IRB fees for continuing renewals and/or amendments.

Post Award considerations

  • Holdback: Industry Sponsors sometimes withhold 10% - 15% of the total contract amount, paid at study closeout.
  • Refusal of payment: even if clinical services are completed, if they are done incorrectly, outside of the specified time frame, or not reported correctly by the CRC – a sponsor can reduce or refuse payment.
  • Reimbursement schedules vary and can be monthly, quarterly, or following the companies’ internal audit (monitoring) of the data.
  • Pharmaceutical companies may batch payments for several studies, resulting in misapplied or unapplied payments.

I have a grant proposal - how do I get started?

Review Your Research Pre-award Pathway above to understand which research administration offices will be involved in your project.

For Emory Department of Pediatrics Faculty, complete the Intent to Submit Form.

For Children's research process, click here.

I have a clinical trial - how do I get started?

Review Your Research Pre-award Pathway above to understand which research administration offices will be involved in your project. Begin your regulatory submission(s) right away, then:

For Emory Department of Pediatrics Faculty, complete the Intent to Submit Form.

For Children's research process, complete click here.

The sponsor sent a confidentiality (CDA) or non-disclosure (NDA) agreement - should I sign it?

All legal documents must first be reviewed by the appropriate institution. To determine where to route your CDA/NDA, please go here and follow the process as outlined.

 

What are the roles of Pre-Award and Post-Award analysts?

Click here for an overview of roles and responsibilities.

How do I find out if my project was awarded/funded?

Contact your pre-award administrator in either Emory RAS or Children's ORA.

Where can I find my smartkey and/or project number?

Both are listed on your Notice of Award. You can also contact your post-award administrator.

How do I order supplies for my study?

You or your staff may directly order supplies in the Emory Express system.

How do I access funds in my discretionary account?

Contact the RAS

For key facts and rates for Emory University and Children’s Healthcare of Atlanta that are often required when completing grant applications. Information such as Federal Tax ID, links to institution fact sheets, F&A rates and more is included.

To report any changes or corrections, please email Sarah Marie Huban.