Safety and Confidentiality Issues

ADVERSE EVENTS

At any time throughout the study, any adverse event reported by a subject or observed by the study investigator will be recorded on the case report form and subsequently evaluated by the Principal Investigator for its relation to the study procedure and whether or not any corrective action need be taken. All applicable adverse events will be reported to the IRB.

Formal adverse event evaluation will be conducted at the end of each of the 8 procedure administration weeks. At that time, a review of the subject’s medication use will also be conducted and any changes will be recorded and evaluated for any likelihood of impact on the subject’s participation in the study.

When the weekly adverse event and medication review evaluation does not coincide with a subject visit, the evaluation will be conducted via telephone. Three attempts will be made at varying times on the allotted day to contact the subject to complete this weekly evaluation. These calls and the outcome will be recorded on the TELEPHONE VISIT LOG case report form.

Adverse events will be recorded on the ADVERSE EVENTS LOG case report form.

MONITORING OF THE CLINICAL STUDY

The Monitor will assure that the investigator is executing the protocol as outlined and intended. This includes insuring that a signed informed consent form has been attained from each subject prior to commencing the protocol, that the study procedure protocol is administered as specified, and that all study evaluations and measurements are taken using the specified methods and correctly and fully recorded on the appropriate clinical case report forms.

SUBJECT PRIVACY AND CONFIDENTIALITY

Records for each subject in the phase three clinical trial will be maintained in separate files in a locked filing cabinet at the test site. The Principal Investigator will be responsible for ensuring that all records for a subject are stored in that subject’s file at all times other than when information is being recorded on them.

Once a subject’s participation in the study is complete and all of the required records are in the subject’s file, copies of the documents may be made and supplied to the study Sponsor who will store them in a locked filing cabinet. Copies of subjects’ case report forms will also be sent to Regulatory Insight, Inc. for the purpose of monitoring the data collection process and analysis of results. Regulatory Insight, Inc. will also maintain these copies in a separate clinical study file that is kept in a locked filing cabinet. The original records will be maintained at the test site upon completion of the study in their original files and stored in a locked filing cabinet.

Subjects’ identities will be kept confidential by assigning each subject a subject ID upon acceptance into the study. The subject ID will comprise the investigator’s first and last name initials and a three-digit number that will be determined based upon the subject’s order of entry into the study. For example, the eighth subject to be enrolled under Principal Investigator John Black would have a subject ID of JB008. Neither the study Sponsor nor Regulatory Insight, Inc. will receive any additional identifying information about a subject and will therefore have no way of linking a subject ID to a particular subject and his or her results.

INFORMED CONSENT

• Informed consent will be an agreement between the study PI and each subject, having the capacity to understand and make an informed decision. Consent will be obtained prior to each potential subject’s participation in this clinical trial.
• Each subject participating in this clinical trial will be made aware of the fact that his or her participation involves research and the intent of the research, the expected duration of participation and a description of the procedures that will be followed.
• Each subject will be made aware of the reasonably expected benefits he or she might receive, as well as any risks or potential discomfort that are involved.
• Each subject will be made aware of alternative procedures that are available to him or her.
• Each subject will be made aware that his or her records will remain confidential, but that the FDA and the IRB has the right to inspect his or her records.
• Each subject will be told that his or her participation in the clinical trial is voluntary, without force or influence from the investigator or sponsor.
• Each subject will be given the name and method of contacting the appropriate person(s) to answer his or her questions about the research and in the event of research-related injury.

The informed consent form can be found in Appendix F.

CASE REPORT FORMS

The case report forms that will be used to collect the data from each subject inthis phase three clinical trial can be found in Appendix G.

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All physicians in Pinellas, Hillsborough, Pasco and Manatee County, Florida, who have patients diagnosed with Parkinson’s disease, should know that Pico-Tesla Magnetic Therapies are currently conducting clinical trials. Parkinson’s patients will be subject to low strength pulsed magnetic fields around the body using the new Resonator® device. This is a paid clinical trial for all patients who qualify for and complete the procedure.

Pico-Tesla is holding these clinical trials in their Clearwater, FL office. Clearwater is located on the west coast of Florida, just 240 minutes west of Tampa. Any interested party can contact Pico-Tesla for more information.