Drug Study

Who needs to be listed on Form FDA 1572 in Box 6 as a sub-investigator?

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.

Who needs to be listed on the delegation of authority log?

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.

Who needs to complete financial disclosure forms?

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

Can I use an investigational drug outside of a clinical trial?

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.