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 CHOA PIs and Emory Faculty* outside of Department of Pediatrics, complete this form.

*please also contact your deparment's RAS


Additional Information

Click here for a weekly pre-award status report for industry sponsored clinical trials.

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 CHOA PIs, complete this form.

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 CHOA PIs, complete this form.

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

All legal documents must first be reviewed by the institution.

For Emory Department of Pediatrics Faculty, please send the agreement and sponsor contact information to Emory Contracts.

For CHOA PIs, please send the agreement and sponsor contact information to CHOA Contracts.

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 CHOA 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 hire research staff?

Contact your business manager.

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 your financial analyst.

For key facts and rates for Emory University and Children’s Healthcare of Atlanta that are often required when completing grant applications, see here. 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 click here.