Frequently Asked Questions

Yes. Secure email configuration which allows email communication during the submission process has been completed and the FDA considers these email domains secure:

• @emory.edu
• @emoryhealthcare.org

Use of secure email allows communication between FDA and sponsors. It is not a substitute for formal submissions. Formal submissions (e.g., new INDs and amendments) must be submitted to the respective center's document room (paper submissions) or via the electronic gateway, as applicable.

For more information see FDA Guidance:

The FDA definition of sub-investigator includes any individual member of the research team who assists the investigator and makes a direct and significant contribution to the data. The determination of whether an individual should be included as a sub-investigator should be based on whether the individual is performing significant duties related to the trial.

In general, if an individual is directly involved in the performance of study-specific procedures that make a significant contribution to the data and/or the collection of data, that person should be listed on the 1572. Anyone who documents results or findings on a study-specific form always should be listed on the Form 1572. It is not necessary to list hospital staff, including nurses, residents, or fellows who provide ancillary or intermittent care if those individuals do not make a direct and significant contribution to the clinical data, e.g., a physician who temporarily dealt with an adverse effect or a temporary substitute for any research staff.

Specific examples of staff that should be listed on Form 1572:

• Research Nurses & Coordinators who perform critical study functions and make direct and significant contributions to the data should be listed. For example, a research coordinator who recruits subjects, collects and evaluates study data, or maintains study records should be included on the 1572.

• *Mid-level practitioners who perform procedures required by the protocol and collect data from those procedures should be listed. (* FDA inspectors at Emory sites have requested this inclusion.)

• Research interviewers who collect data from subjects should be listed.

• *Infusion nurses who administer the investigational product & collect data required by the protocol should be listed.

• Statisticians who contribute to the design & analysis of data should be listed.

• *Specialists, such as surgeons who collect tissue, would need to be listed if performing protocol specific procedures that make a significant contribution to the data.

Specific examples of staff that may not need to be listed on Form 1572:

• Nursing staff whose primary contact with subjects is in the context of providing non-research clinical care would not need to be listed. If nursing staff are performing protocol procedures and collecting data, they should be included on the 1572.

• Lab technicians and phlebotomists would not need to be listed unless performing protocol specific procedures that make a significant contribution to the data.

• Pharmacists who prepare investigational product and maintain drug accountability would not need to be listed for industry sponsored trials unless the sponsor requires. For investigator-initiated trials, where the pharmacist is involved in activities such as protocol development or randomization, the pharmacist should be listed on the 1572.

• Staff such as regulatory specialists & administrators would not need to be listed if they do not collect data.

• Specialists, such as radiologists, would not need to be listed if performing standard of care procedures.

All individuals listed on Form FDA 1572 should also be listed on the Delegation of Authority log & trained on the protocol & their responsibilities. This training must be documented by a training log/record that includes the training topics (e.g., protocol and investigator's brochure) and name of trainer.

All Individuals listed on Form FDA 1572 must provide information to the IND sponsor about their financial interests. Financial disclosure certification form (DOCX)

Sponsor-investigators are required to collect this information from all participating investigators and sub-investigators at all sites involved in the clinical investigation prior to allowing participation in the investigation. This form does not need to be completed for studies which are IND exempt.

Expanded Access regulations provide a mechanism to use or administer an investigational drug outside of a clinical trial. FDA regulations use the term "Expanded Access" although you may also see the terms "compassionate use" or "treatment use". Expanded access for drugs permits the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition for whom there are no comparable or satisfactory alternative treatment options. See Expanded Access.

All individuals listed on the investigator agreement should also be listed on the Delegation of Authority log & trained on the protocol & their responsibilities. This training must be documented by a training log/record that includes the training topics (e.g., protocol and device operation) and name of trainer.

All Individuals listed on the investigator agreement or participating in the investigation must provide information to the IDE sponsor about their financial interests. Sponsor-investigators are required to collect this information from all participating investigators at all sites involved in the clinical investigation prior to allowing participation in the investigation. This includes studies conducted under an abbreviated IDE. See financial disclosure certification form (DOCX).

NOTE: The FDA financial disclosure certification form is both separate from and in addition to the information collected by Emory's Conflict of Interest Office and/or any financial disclosure forms required by NIH.

Expanded Access regulations provide a mechanism to use an unapproved medical device outside of a clinical trial. FDA regulations use the term "Expanded Access" although you may also see the terms "compassionate use" or "treatment use". Expanded access for devices includes emergency use and treatment use of an investigational device to treat a patient with a serious or immediately life-threatening disease or condition for whom there are no comparable or satisfactory alternative treatment options. See Expanded Access.

There are numerous preparations that are marketed in the U.S. as dietary supplements. The definition of dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994 includes:

• A dietary supplement is a product taken by mouth that is intended to supplement the diet and that contains a dietary ingredient.

• The dietary ingredients in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.

• Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gel caps, liquids or powders.

Under DSHEA, a dietary supplement is not considered a drug and is not subject to the premarket approval requirements for drugs if the intended use for which it is marketed is only to affect the structure or any function of the body (i.e., not intended to be used for a therapeutic purpose).

Whether an IND is needed for a clinical investigation evaluating a dietary supplement is determined by the intent of the clinical investigation. If the clinical investigation is intended only to evaluate the dietary supplement's effect on the structure or function of the body, an IND is not required. However, if the clinical investigation is intended to evaluate the dietary supplement's ability to diagnose, cure, mitigate, treat, or prevent a disease, an IND is required under part 312.

For example, a clinical investigation designed to study the relationship between a dietary supplement's effect on normal structure or function in humans (e.g., calcium and bone mass) or to characterize the mechanism by which a dietary supplement acts to maintain such structure or function (e.g., fiber and bowel regularity) would not need to be conducted under an IND. However, a clinical investigation designed to evaluate a dietary supplement's ability to prevent osteoporosis or to treat diarrhea or constipation would need to be conducted under an IND under part 312.

See FDA Guidance IND Determination (PDF) for further information.

The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." If a lawfully marketed dietary supplement is studied for its effects on diseases in the proposed investigation (i.e., to cure, treat, mitigate, prevent, or diagnose disease including its associated symptoms), then it is considered an investigational new drug and will be subject to IND requirements.

No. When a lawfully marketed dietary supplement is studied for its dietary supplement use (i.e., structure and/or function claims), an IND is not required. Structure and function claims are statements that describe the effect a dietary supplement may have on the structure or function of the human body. Refer to FDA Guidance Structure/Function Claims, Small Entity Compliance Guide for further information.

No. The criteria for IND exemption requires that the drug product is lawfully marketed as an FDA approved drug in the United States. Unless the dietary supplement used in the research study is also a lawfully marketed FDA-approved drug, the IND exemption criteria cannot be considered.

Yes. If the clinical investigation is intended to evaluate the dietary supplement's ability to diagnose, cure, mitigate, treat, or prevent a disease, an IND is required, even though you can buy it in a health food store.

No. According to FDA Guidance, the clinical condition of study subjects (e.g., the presence or absence of disease) has no bearing on whether the study is subject to the IND requirements. The definition of clinical investigation refers only to the fact that subjects are involved in an experiment. It makes no distinction between healthy subjects or those with a disease.

No. Whether the IND regulations apply to a planned clinical investigation does not depend on whether the intent of the clinical investigation is commercial or noncommercial.