Research with investigational or unlicensed test articles (devices)

VIII.02

 

 

Research with investigational or unlicensed test articles (devices)

 

 

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Objective

Investigators utilizing investigational devices must conform to FDA regulations covering investigational devices.  The Organization should be able to evaluate whether the FDA regulations regarding investigational articles are applicable.

 

Policy/Procedure

I.              When utilizing investigational devices, the investigator is responsible for:

A.     Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations.

B.     Protecting the rights, safety, and welfare of participants under the investigator’s care.

C.     The control of devices under investigation.

 

II.           An investigator may determine whether potential participants would be interested in participating in an investigation, but shall not request the written informed consent of any participant to participate, and shall not allow any participant to participate before obtaining CPHS and FDA approval.

 

III.         An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, applicable parts of the FDA regulations, and any conditions of approval imposed by CPHS or FDA.

 

IV.        An investigator shall permit an investigational device to be used only with participants under the investigator’s supervision.  An investigator shall not supply an investigational device to any person not authorized to receive it. 

 

V.           A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required by FDA regulations.  The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study.

 

VI.        Upon completion or termination of a clinical investigation or the investigator’s part of an investigation, or at the sponsor’s request, an investigator shall return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.

 

VII.      A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator’s participation in an investigation:

 

A.     All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports.

B.     Records of receipt, use or disposition of a device that relate to:

1.      The type and quantity of the device, the dates of its receipt, and the batch number of code mark.

2.      The names of all persons who received, used, or disposed of each device.

3.      Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.

C.     Records of each participant’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:

1.      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.

2.      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.

3.      A record of the exposure of each participant to the investigational device, including the date and time of each use, and any other therapy. 

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

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

 

VIII.   An investigator or sponsor shall maintain the records required 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.

 

IX.        An investigator or sponsor may withdraw from the responsibility to maintain records for the period required and transfer custody of the records to any other person who will accept responsibility for them, in accordance with FDA regulations.

A.     Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.

 

X.           An investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept).

 

XI.        An investigator shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation.

 

XII.      An investigator shall permit authorized FDA employees to inspect and copy records that identify participants, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or CPHS have not been submitted or are incomplete, inaccurate, false, or misleading.

 

XIII.         An investigator shall prepare and submit the following complete, accurate, timely reports:

 

A.     An investigator shall submit to the sponsor and to the CPHS a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.

B.     An investigator shall report to the sponsor, within 5 working days, a withdrawal of approval by the CPHS of the investigator’s part of an investigation.

C.     An investigator shall submit progress reports on the investigation to the sponsor, the monitor, and the CPHS at regular intervals, but in no event less often than yearly.

D.     An investigator shall notify the sponsor and the CPHS of any deviation from the investigational plan to protect the life or physical well-being of a participant in an emergency.  Such notice shall be given as soon as possible, but in no event later than 5 working days after the emergency occurred.  Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human participants, from the FDA and CPHS also.

E.      If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the CPHS within 5 working days after the use occurs.

F.      An investigator shall, within 3 months after termination or completion of the investigation or the investigator’s part of the investigation, submit a final report to the sponsor and the CPHS.

G.     An investigator shall, upon request by the CPHS or FDA, provide accurate, complete, and current information about any aspect of the investigation.

 

XIV.         When the sponsor or investigator claims that an investigational device is not a significant risk, CPHS shall make a determination whether or not the device is not a significant risk.

 

XV.           In deciding whether or not a medical device is a significant risk, CPHS considers if the device:

A.     Is intended as an implant and presents a potential for serious risk to the health, safety or welfare of a participant.

B.     Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a participant.

C.     Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a participant.

D.     Otherwise presents a potential for serious risk to the health, safety, or welfare of a participant.

 

XVI.   If CPHS determines that an investigation, presented for approval as a non-significant risk device involves a significant risk device, it notifies the investigator and, where appropriate, the sponsor.

 

Applicable Regulations and Guidelines

21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html )

21CFR 56( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html )

38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html )

45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html )

ICH E6 (http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB )

OPRR letter dated May 5, 1995 -  Subject: Exempt Research and Research That May Undergo Expedited Review (http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc95-02.htm )

OHRP Guidance on the Involvement of Prisoners in Research dated May 23, 2003

 (http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.pdf

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