· If the proposed research involves an investigational or humanitarian use device, complete this form and submit it along with the Human Subjects Protocol for review by the IRB.
IRB Protocol Title:
Principal Investigator on Protocol:
1. Name of device:
2. Name of IDE or HDE holder:
3. Has the device been approved by the FDA? Yes No
If yes, complete Item a.
a. Does the proposed research use the device for the purposes for which it has been approved? Yes No
4. Indicate device status (check as many as apply).
Investigational Device Exemption (IDE) Number:
How long has it been since the IDE was submitted? If less than 30 days, also enter end date of 30-day waiting period:
-OR- FDA Exemption Letter
Significant Risk Device
-OR- Non-Significant Risk (NSR) Device
Attach a letter from the sponsor discussing the reasons for the risk classification.
Humanitarian Device Exemption (HDE) Number:
How long has it been since the HDE was submitted? If less than 75 days, also enter end date of 75-day waiting period:
Commercially Available
Other (Describe: )
5. Will device be billed to participants?
6. If hazards to an individual participant occur, describe
(a) the criteria that will be used to decide whether that participant should be removed from the study;
(b) the procedure for removing such participants when necessary to protect their rights and welfare; and
(c) any special procedures, precautions, or follow-up that will be used to ensure the safety of other currently enrolled participants.
7. Indicate the point at which the differences in outcomes between participants and controls will be considered sufficiently significant to eliminate the need for additional participants, or to require modification of the disclosure made to continuing and prospective participants because of greater information concerning relative risks.
8. Will a Data and Safety Monitoring Board (DSMB) review the data from this study?
If Yes, complete Items a-d. If not and the research involves greater than minimal risk, complete Item e. Yes No
Notes. (1) NIH-funded Phase III studies must have a DSMB. (2) For protocols conducted at the GCRC, attach the completed and signed PITTMAN GCRC DATA SAFETY MONITORING PLAN as submitted with the GCRC application (see page 14). Please enter “GCRC” in Item a, below.
a. Who will make up the DSMB?
b. Will there be an interim analysis?
c. At what points will the data be reviewed?
d. Describe how the plan will work:
e. Describe the plan for monitoring the data to ensure the safety of participants. Describe what data will be monitored, how often it will be monitored, who will monitor it, what data will be evaluated, and the decisions that will be made in response to the evaluation.
9. State any differences in the serious adverse event reporting between this particular protocol and 45 CFR 46 or 21 CFR 312 (or enter "None").
10. Are you requesting that the UAB IRB designate the device as a Non-Significant Risk (NSR) device? Yes No
If yes, complete Items a. and b.
a. Indicate whether the device will be used for any of the following:
As an implant
For use supporting or sustaining human life
For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health
If any of the above are checked, the device is a significant risk device.
b. Describe why this use of the device does not present a potential for serious risk to the health, safety, or welfare of a subject.
11. Attach a copy of the Investigator's Agreement.
12. Reporting of handling, storage, and documentation of investigational devices:
a. Does investigator hold IDE? Yes No
b. Will device handling, storage, and documentation be tracked without an independent monitor (e.g., CRO, other specified person)? Yes No
If No to Item b, name of monitor:
c. Describe the plan for storage, control, and dispensing of the device so that only authorized investigators will use the device and they will use the device only in participants who have provided consent:
If Yes to Items a and b, you must submit Investigational Device Accountability Records (FOR238) at time of continuing review. NOTE: Also, these studies are prioritized for review in the OIRB audit plan.
NOTE: All monitoring reports must be submitted to the OIRB for review within 10 working days of receipt by the Investigator.
FOR229 Page 1 of 4
3/24/15
/ Investigator Responsibilities for Handling, Inventory, and Disposing of Devices /The responsibilities for investigators conducting investigations on devices are analogous to those for investigators conducting studies on drugs. Generally, the investigator is responsible for ensuring that an investigation is conducted according to the signed written agreement, the investigational plan and applicable FDA regulations; for protecting the rights, safety, and welfare of subjects under the investigator’s care; and for control of the devices under investigation.
· An investigator must conduct the investigation in accordance with the signed agreement with the sponsor, the investigational plan, any applicable FDA regulations, particularly those on investigational devices, and any conditions of approval imposed by an IRB or FDA.
· An investigator must permit an investigational device to be used only with subjects under the investigator’s supervision. An investigator must not supply an investigational device to any person unauthorized under the regulations to receive it.
· Upon completion or termination of a clinical investigation or the investigator’s part of the investigation, or at the sponsor’s request, an investigator shall return to the sponsor any remaining supply of the device or dispose of the device in accordance with the sponsor’s directions (21 CFR §812.110).
In addition, the regulations require participating investigators to discharge obligations with regard to documentation of device use. In particular, the FDA regulations list the following record keeping obligations:
Records.
(a) Investigators records. Participating investigators must 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 relates to (see sample FOR238):
a. The type and quantity of the device, the dates of its receipt, and the batch number or code mark.
b. The names of all persons who received, used, or disposed of each device.
c. Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
GUI337 - Guidance Page 4 of 4
10/04/07