Electronic Source Data in Clinical Investigations: Guidance for Industry

Description

This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.

Scope & Applicability

Regulatory Context

• 21CFR812.140§ 812.140 Records.

  (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:Read full regulation →

• 21CFR11.10§ 11.10 Controls for closed systems.

  Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate theRead full regulation →

• 21CFR312.50§ 312.50 General responsibilities of sponsors.

  Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan Read full regulation →

• 21CFR312.62§ 312.62 Investigator recordkeeping and record retention.

  (a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug tRead full regulation →

• 21CFR11.3§ 11.3 Definitions.

  (a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.Read full regulation →

• 21CFR312.3§ 312.3 Definitions and interpretations.

  (a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:Read full regulation →

• 21CFR50.3§ 50.3 Definitions.

  As used in this part:Read full regulation →

• Bioresearch Monitoring Program

  Amy Lightner, MD

  2025-06-03

• Clinical Investigator

  Namita A. Goyal, M.D.

  2024-10-22

• Bioresearch Monitoring Program/IRB

  Konrad Rejdak, M.D., Ph.D.

  2024-08-13

• Clinical Investigator

  Maria W. Greenwald, M.D.

  2023-10-31

• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

  Fagron Group B.V.

  2022-06-28

• CGMP/Dietary Supplement/Adulterated/Misbranded

  Hawaii Pharm LLC

  2020-05-05

• Investigational Device Exemptions (Clinical Investigator)

  Kennedy, Philip R.

  2020-04-07

• Clinical Investigator

  James R. Corbett, M.D.

  2020-03-10

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