Case histories are defined in 21 CFR 812.140(a)(3) and include the case report forms and supporting data including, for example, signed and dated informed consent forms and medical records including 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 period of records retention to which the investigator is contractually obligated to a study sponsor can vary depending on the nature of the clinical study and the agreed terms of the contract. Read the contract carefully for specific record retention obligations that may extend beyond the period required by policy, laws, rules, and regulations.
Yes, the investigator can claim record retention costs. These costs are typically captured in the study contract costs as an invoiceable item. These costs may be paid by the sponsor as a lump sum for the full retention period, or may need to be invoiced to the sponsor quarterly or annually.
Yes, if investigators have been designated to retain certain records on behalf of the institution per DHHS regulations, they must retain the original consent documents, with the other study records in some form. Such records may be preserved in hardcopy, electronic or other media form and must be accessible for inspection and copying by authorized representatives of HHS at reasonable times and in a reasonable manner. Retention of multiple copies of each record is not required.
Yes, in November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. Based on this document, the clinical investigator should retain control of the records (i.e., completed and signed eCRF or certified copy of the eCRF). If requested, the clinical investigator should provide FDA with access to the records that serve as the electronic source data. When data elements are transcribed from paper sources into an eCRF, the clinical investigator(s) must also retain the paper sources, or certified copies.
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
Yes, DHHS’ regulations on the protection of human research subjects apply even if the study is not FDA-regulated. DHHS’ study record retention regulations require institutions to retain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research. Retained records must include the signed informed consent form or the short form with written research summary unless the IRB waived the requirement for informed consent or the requirement for documentation of informed consent. The “study completion date” as defined in the ClinicalTrials.gov glossary, is the date that the final data for a clinical study were collected because the last study participant has made the final visit to the study location (that is, 'last subject, last visit').
The sponsor usually informs the investigator(s)/institution(s) in writing of the need for record retention and notifies the investigator(s)/institution(s) in writing when the trial related records are no longer needed and the FDA has been notified.
Yes, when performing a routine billing audit, Medicare may request billing records up to 10 years. In the event the billing review involved claims for protocol services, study-related records could be needed to understand the billing.
The successor Investigator and the Institution are responsible for retaining the clinical study records when the Investigator leaves the Institution. Investigators should follow the institution’s policies and procedures for retaining records. If investigators who have been designated to retain records on behalf of the institution leave that institution, the investigators and the institution should identify the successor responsible for maintaining those institutional records for the period of time required.