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.
Yes. Secure email configuration which allows email communication during the submission process has been completed and the FDA considers these email domains secure:
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: Best Practices for Communication Between IND Sponsors and FDA During Drug Development