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(a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:
(1) All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports.
(2) Records of receipt, use or disposition of a device that relate to:
(i) The type and quantity of the device, the dates of its receipt, and the batch number or code mark.
(ii) The names of all persons who received, used, or disposed of each device.
(iii) Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
(3) 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:
(i) 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.
(ii) 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.
(iii) A record of the exposure of each subject to the investigational device, including the date and time of each use, and any other therapy.
(4) The protocol, with documents showing the dates of and reasons for each deviation from the protocol.
(5) Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigations or a particular investigation.
(b) Sponsor records. A sponsor shall maintain the following accurate, complete, and current records relating to an investigation:
(1) All correspondence with another sponsor, a monitor, an investigator, an IRB, or FDA, including required reports.
(2) Records of shipment and disposition. Records of shipment shall include the name and address of the consignee, type and quantity of device, date of shipment, and batch number or code mark. Records of disposition shall describe the batch number or code marks of any devices returned to the sponsor, repaired, or disposed of in other ways by the investigator or another person, and the reasons for and method of disposal.
(3) Signed investigator agreements including the financial disclosure information required to be collected under § 812.43(c)(5) in accordance with part 54 of this chapter.
(4) For each investigation subject to § 812.2(b)(1) of a device other than a significant risk device, the records described in paragraph (b)(5) of this section and the following records, consolidated in one location and available for FDA inspection and copying:
(i) The name and intended use of the device and the objectives of the investigation;
(ii) A brief explanation of why the device is not a significant risk device:
(iii) The name and address of each investigator:
(iv) The name and address of each IRB that has reviewed the investigation:
(v) A statement of the extent to which the good manufacturing practice regulation in part 820 will be followed in manufacturing the device; and
(vi) Any other information required by FDA.
(5) Records concerning adverse device effects (whether anticipated or unanticipated) and complaints and
(6) Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.
(c) IRB records. An IRB shall maintain records in accordance with part 56 of this chapter.
(d) Retention period. An investigator or sponsor shall maintain the records required by this subpart 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, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission, or a request for De Novo classification.
(e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period required in paragraph (d) of this section 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. Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.
[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 46 FR 8957, Jan. 27, 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb. 2, 1998; 83 FR 7387, Feb. 21, 2018; 83 FR 7387, Feb. 21, 2018]
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