The SI has all the responsibilities of investigators in any clinical trial.
The SI is responsible for assuring that:
As investigator, the SI must administer the investigational drug only to subjects under his/her direct supervision, or under the supervision of a sub-investigator responsible to the investigator. The SI must also ensure that the investigational drug is not given to any person not authorized to receive it. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under 21 CFR 312.59 [4].
Accurate documentation of the following must be maintained.
As investigator, the SI will maintain accurate case histories that record all observations and other data pertinent to the investigation on each subject who received the investigational drug and each subject who was a control in the investigation.
Case histories include the case report forms, supporting data such as signed, dated consent forms, and medical record information including, for example, progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.
The SI is responsible for maintaining adequate records of the disposition of the drug, including dates, quantity, and use by subjects.
SIs are required to maintain:
The sponsor-investigator (SI):
As investigator, the SI must take adequate precautions to ensure the safe and secure handling of the investigational drug if it is a controlled substance. This includes proper storage in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.
Links:
[1] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.60
[2] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.66
[3] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.61
[4] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.59
[5] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.62
[6] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.62
[7] https://hso.research.uiowa.edu/sites/hso.research.uiowa.edu/files/forms/2016%20Guide%20and%20SOP_0.pdf
[8] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.68
[9] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.69