Frequently Asked Questions

Clinical Study Record Retention Requirements What types of specific documents should the investigator retain at the completion of a clinical study with an IND (Investigational New Drug) Application? All study documents should be retained by the Investigator, including, but not limited to: all Case Report Forms (CRFs/eCRFs), data Clarification forms collected complete subject identification list audit certificate (if required) Final trial close out monitoring report Randomization/Treatment allocation and decoding document IRB communications and Final report to IRB/IEC Clinical study report Records of disposition of drug, including dates, quantity, and use by subjects Clinical case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Any clinical records used to support billing submitted and payments received for protocol services 3

Clinical Study Record Retention Requirements

All study documents should be retained by the Investigator, including, but not limited to:

all Case Report Forms (CRFs/eCRFs), data Clarification forms collected
complete subject identification list
audit certificate (if required)
Final trial close out monitoring report
Randomization/Treatment allocation and decoding document
IRB communications and Final report to IRB/IEC
Clinical study report
Records of disposition of drug, including dates, quantity, and use by subjects
Clinical case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
Any clinical records used to support billing submitted and payments received for protocol services