Record Retention

As the PI, you must carefully maintain all records for each research protocol. Follow the basics of good documentation:

• Keep records organized and indexed so they are easy to access and retrieve efficiently.
• Ensure your documentation is attributable, legible, timely, original, accurate, and complete.
• Record, handle, and store all clinical trial information to allow for accurate reporting, interpretation, and verification.
• Protect the confidentiality of records that could identify participants.
• Proper documentation should be available for source documentation at the time of data abstraction, monitoring visits, audits, or inspections.
• Store permanent electronic records (like emails, IMs, text messages, electronic documents, spreadsheets, presentations, images, maps, videos, blogs, and other social media communications) electronically, using an approved electronic records system if applicable.
• Keep non-email electronic records in their native format, organized on an NIH network drive, SharePoint site, or other agency electronic information system.
• Keep a regulatory file with current and accurate records of all study documents as required by relevant regulations.
• If research source documents can't be placed in the medical record, maintain them in a research record created by your study team.
• Store all records on a secure network location. If records are in paper form, keep them in a locked cabinet with limited access.

Investigators and sponsors are required to retain records and reports after the trial is closed for the longest of the following intervals:

• NIH Requirements: follow NIH Manual Chapter 1743 - Managing Federal Records to determine how long to keep records. For most records, this is at least 3 years.
• FDA Requirements:
  • Two years after a marketing application is approved for the drug.
  • If an application is not approved for the drug, records must be maintained for 2 years after the shipment and delivery of the drug for investigational use is discontinued and the FDA has been notified.

Investigators are responsible for ensuring recordkeeping and record retention requirements are met as per FDA regulations and NIH policy.

Disposition of Drug:

• Maintain adequate records of the disposition of the drug, including dates, quantity, and use by participants.
• If the investigation is terminated, suspended, discontinued, or completed, return the unused supplies of the drug to the sponsor or otherwise provide for the disposition of the unused supplies.
• Some or all of these duties may be delegated to other appropriate individuals. For example, at the NIH Clinical Center (CC), the CC Pharmacy Department is responsible for the receipt, storage, dispensing, and disposition of all investigational drugs.

Case Histories:

• Prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation for each individual administered the investigational drug or employed as a control.
• Case histories include the case report forms and supporting data, such as signed and dated consent forms and medical records, including progress notes of the physician, the individual's hospital chart(s), and the nurses' notes.
• Document in the case history for each individual that informed consent was obtained prior to participation in the study.

Data from Withdrawn Subjects:

• When a participant withdraws from a study conducted under an IND, the data collected on the participant up to the point of withdrawal remains part of the study database and may not be removed.
• You may not continue to access the participant's medical record or other confidential records for additional research purposes unless the participant has provided consent to do so.

As an investigator, you are responsible for keeping accurate, complete, and current records as specified in 21 CFR 812.140. These records include:

• All protocol-related correspondence with other investigators, IRB, sponsor, monitors, or the FDA.
• Records of receipt, use, or disposition of a device, including:
  • The type and quantity of the device, the dates of its receipt, and the batch number or code mark.
  • The names of all persons who received, used, or disposed of each device.
  • Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
• Records of each subject's case history and exposure to the device, which must include:
  • Case report forms and supporting data, such as signed and dated consent forms and medical records, including progress notes of the physician, the participant's hospital chart(s), and the nurses' notes.
  • Documents evidencing informed consent and, for any use of a device by the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent. The case history for each participant should document that informed consent was obtained before participation in the study.
  • All relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each participant upon entering and during the course of the investigation, including information about relevant previous medical history and the results of all diagnostic tests.
  • A record of the exposure of each participant to the investigational device, including the date and time of each use.
• The protocol and documentation (date and reason) for each deviation from the protocol.
• Any other records that the FDA requires to be maintained by regulation or by specific requirement for a category of investigations or a particular investigation.