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RecordsSponsor Records for Significant Risk Device Studies The sponsor must maintain accurate and complete records relating to the investigation under §812.140. These records include:
Sponsor Records for Nonsignificant Risk Device Studies The following records must be maintained in one location and available for FDA inspection under §812.2(b):
The sponsor must also maintain records concerning complaints and adverse device effects whether anticipated or not [§812.140(b)(5)]. Investigator Records for Significant Risk Device Studies The investigator must maintain accurate and complete records relating to the investigation under §812.140. These records include:
Investigator Records for Nonsignificant Risk Device Studies Clinical investigators must maintain the records of each subjects case history and exposure to the device under §812.140(a)(3)(i). Case histories include case report forms and supporting data, including signed and dated consent forms and medical records, including progress notes of the physician, the individuals hospital chart(s), and the nurses notes. Records must include documents demonstrating informed consent and, for any use of a device 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 of each individual must document that informed consent was obtained prior to participation in the study. Sponsors and investigators must maintain the required records for a period of two years after the date the investigation is completed or terminated or the records are no longer required to support a PMA or PDP, whichever date is later. An investigator or sponsor may withdraw from the responsibility to maintain records for the time required by transferring custody to another person who will accept responsibility for them. If an investigator or sponsor transfers custody of the records to another person, FDA must be notified within 10 working days after the transfer occurs. Sponsors, IRBs, and investigators are required to permit authorized FDA employees reasonable access at reasonable times to inspect and copy all records of an investigation. Upon notice, FDA may inspect and copy records that identify subjects. FDA has authority to inspect facilities at which investigational devices are being held including any establishments where devices are manufactured, packed, installed, used, or implanted. For more information on FDAs inspection program, see Enforcement of Good Clinical Regulations. References:
Last modified date: July 21, 2003 |
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Center for Devices and Radiological Health / CDRH