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Sponsor Records for Significant Risk Device Studies
The sponsor must maintain accurate and complete records relating to the investigation under §812.140. These records include:
all correspondence including required reports,
records of shipment of the device,
name and address of the consignee
type and quantity of the device, date of shipment, and batch number or code
records of disposition of the device
batch number or code of any devices returned to the sponsor, repaired, or disposed of in other ways
reasons for and the method of disposal
signed investigator agreements including financial disclosure information,
records concerning complaints and adverse device effects whether anticipated or not,
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 name and intended use of the device;
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;
a statement of the extent to which the good manufacturing practices (21 CFR 820) will be followed in manufacturing the device.
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:
all correspondence including required reports,
records of receipt, use, or disposition of the investigational device,
type and quantity of device
date of receipt
batch number or code
name of person that 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
records of each subject's case history and exposure to the device which must include,
signed and dated consent forms
condition of each subject upon entering the study
relevant previous medical history
record of the exposure to the investigational device, including the date and time of each use and any other therapy
observations of adverse device effects
medical records (physician and nurse progress notes, hospital charts, etc.)
results of all diagnostic tests
case report forms
any other supporting data
the protocol and documentation (date and reason) for each deviation from the protocol.
any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.
Investigator Records for Nonsignificant Risk Device Studies
Clinical investigators must maintain the records of each subject’s 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 individual’s 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 FDA’s inspection program, see Enforcement of Good Clinical Regulations.
References:
Computerized Systems Used in Clinical Trials
http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm
http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf
Last modified date: July 21, 2003
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