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 PI for its relation to the study procedure and whether or not any corrective action needs to be taken. All applicable adverse events will be reported to the IRB.
Formal adverse event evaluation will be conducted at each of a subject‘s test site visits.
MONITORING OF THE STUDY
Monitoring of this pilot study will be according to the Pico-Tesla MAGNECEUTICAL® Company Clinical Trial Monitoring Plan document, contained in Appendix E.
SUBJECT PRIVACY AND CONFIDENTIALITY
Records for each subject in this pilot study will be maintained in separate files in a locked filing cabinet at the test site. The PI 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 outcome analysis. Regulatory Insight, Inc. will also maintain these copies in a separate 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 pilot study.
- Each subject participating in this pilot study 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 pilot study is voluntary, without force or influence from the PI 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 C.
CASE REPORT FORMS
The case report forms that
will be used to collect the data from each subject in this pilot trial can be found in Appendix D.
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