HRPP Manual Section 4-7-A

4-7-A, Recordkeeping for Investigators

“The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.” 45 CFR 46.115 (b)

“The records required by this regulation shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable.” 21 CFR 56.115 (b)

Investigators are required to retain records relating to the research for at least three years after completion of the research (45 CFR 46.115(b)). Completion of the research occurs when all research and/or clinical investigations involving human subjects is complete and the project has been closed by the Institutional Review Board. In addition, other regulations or requirements may apply and require retention of these records for a longer period of time or require retention of other specific records (e.g. clinical investigations conducted under an IND, IDE, or abbreviated IDE, contract or funding agreement requirements).

Documentation of the Informed Consent of the Subjects
Documentation of the informed consent of the subjects - either the signed informed consent form or the short form and the written research summary - are records related to conducted research that are held by investigators and must be retained by investigators for at least three years after completion of the research, unless the IRB waived the requirement for informed consent or the requirement for documentation of informed consent (45 CFR 46.117). Other documentation of informed consent should be maintained where signed consent was waived (e.g. log for consent obtained orally). These records cannot be de-identified or redacted.

Retention
Records relating to the research that are maintained by investigators (e.g. informed consent documents signed by the subjects) must be retained in some form. Such records may be preserved in hardcopy, or for non-FDA regulated research, may be preserved in electronic or other media form. For FDA regulated research, the criteria under 21 CFR 11 must be met to consider electronic records generally equivalent to paper records. The records must be accessible for inspection and copying by authorized representatives at reasonable times and in a reasonable manner. See MSU’s Research Data: Management, Control, and Access for best practices. https://rio.msu.edu/research-data  The Principal Investigator is responsible for assuring that records related to the research are appropriately maintained.

If investigators leave MSU, the Principal Investigator or their department should identify the successor who is responsible for maintaining those records, either at MSU or wherever the records are relocated when permitted, for the period of time required under the relevant regulations.

Additional Requirements for Investigations Conducted Under an IND

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 to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under 312.59. 21 CFR 312.62(a)

Case Histories
An investigator is required to prepare and maintain adequate and accurate 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.

Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records 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. 21 CFR 312.62(b)

Record Retention
An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.

If the investigator is a sponsor-investigator under 21 CFR 312, the investigator is required to also comply with all sponsor responsibilities, including recordkeeping and record retention under 21 CFR 312.57.

Additional Requirements for Investigations Conducted Under an IDE
A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation. 21 CFR 812.140(a)

Correspondence
All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports. 21 CFR 812.140(a)(1)

Receipt, Use, or Disposition of a Device
Records of receipt, use or disposition of a device that relate to:

  • 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. 21 CFR 812.140(a)(2)

Case History and Exposure to the Device
Records of each subject's case history and exposure to the device. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. Such records shall include:

  • 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 individual shall document that informed consent was obtained prior to 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 subject 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 subject to the investigational device, including the date and time of each use, and any other therapy. 21 CFR 812.140(a)(3)

Protocol and Deviations
The protocol, with documents showing the dates of and reasons for each deviation from the protocol.

Any Other Records
Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigations or a particular investigation.

Record Retention
An investigator or sponsor shall maintain the records required by 21 CFR 812.140 during the investigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.

Record Custody
The FDA regulations for IDEs permit an investigator or sponsor to withdraw from the responsibility to maintain records for the period required in 21 CFR 812.140(d) and transfer custody of the records to any other person who will accept responsibility for them under this part, including the requirements of 812.145 (inspections). However, the investigator is responsible for obtaining prior appropriate approval from University offices such as the Vice President for Research and Graduate Studies, MSU Technologies, and the Human Research Protection Program before such a transfer takes place. In addition, notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.

If the investigator is a sponsor-investigator under 21 CFR 812, the investigator is required to also comply with all sponsor responsibilities, including recordkeeping and record retention under 21 CFR 812.140(b).

Additional Requirements for Investigations Conducted Under an Abbreviated IDE
The investigator is responsible for maintaining the following records, consolidated in one location and available for FDA inspection and copying:

  • The name and intended use of the device and the objectives of the investigation;
  • A brief explanation of why the device is not a significant risk device:
  • The name and address of each investigator:
  • The name and address of each IRB that has reviewed the investigation:
  • A statement of the extent to which the good manufacturing practice regulation in part 820 will be followed in manufacturing the device; and
  • Any other information required by FDA. 21 CFR 812.140(b)(4)
  • Records concerning adverse device effects (whether anticipated or unanticipated) and complaints 21 CFR 812.140(b)(5)

The investigator is also responsible for ensuring that participating investigators maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:

  • Records of each subject's case history and exposure to the device. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. Such records shall include:
    • Documents evidencing informed consent
    • 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 individual shall document that informed consent was obtained prior to participation in the study. 21 CFR 812.140 (a)(3)(i)

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research & Graduate Studies on 8-1-2017.

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