Unanticipated Problems Reporting Form
Contents
1. would also be reportable to the IRB Unanticipated Unexpected An event is unanticipated or unexpected when its specificity or severity is not consistent with the current investigator brochure protocol consent form package insert or label or is unanticipated in its frequency severity or specificity Related An event is related to a research procedures if it was more likely than not to be caused by the research procedures or if it is more likely that not that the event affects the rights and welfare of current participants Adverse Event Is any physical psychological or social harm to subjects during the course of research Event Type Check box that applies O Adverse Event which in the opinion of the principal investigator is both unexpected and related Please attach full SAE and or UADE Report as submitted to Sponsor for review L An unanticipated event related to the research that exposes individuals other than the research participants e g investigators research assistants students the public etc to potential risk L Information that indicates a change to the risks or potential benefits of the research For example a an interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB b a paper is published from another study that shows that the risks or potential benefits have changed _ A breach of confide2. Do you expect this event to occur again O Yes _ No Is the event effectively described in the consent form and protocol L Yes _ No Should the consent form be modified as a result of this event Yes L No If yes please submit your recommended changes Subject Details Subject s age Gender E Male E Female Did this event involve a healthy volunteer _ Yes L No Subject Status O Pre screening O Follow up L Dosed Randomized L Completed Protocol Research Details Enrollment status at your site check one O Open to enrollment C Closed to enrollment select one _ Active subjects and or subjects in follow up _ No active subjects L Study on hold L Study completed No further study related activity at your site Indicate where this research is taking place L Multi center study and the event occurred here L Multi center study but the event occurred off site O Single site study this study is only being conducted at my site My protocol involves L Investigational Drug _ Investigational Device _ Other describe Document Attachments Does this event prompt a change to the Consent Document s L Yes No If yes attach a redlined copy of the document Does this event prompt a change to the protocol Yes No If yes attach a redlined protocol revision Does this event prompt a change to the Investigator s Brochure Package Insert U
3. N sid gt r Z 5416 East Baseline Road Suite 120 Mesa AZ 85206 COMPASS R y Phone 480 832 7373 or 877 660 1IRB LIND Fax 480 832 7376 GUIDING YOU TO SUCCESS www compassitb com Unanticipated Problems Reporting Form Instructions Only items meeting the definition of an unanticipated problem are required to be reported to the IRB All unanticipated problems should be reported to Compass IRB within 10 working days of discovery except when event is a death in which case please report within 5 working days of discovery Please read and complete all sections carefully and attach corresponding report Any missing information may result in a delay in the review Sponsor Protocol Principal Investigators Name Compass IRB Definitions Unanticipated problem Any event or information that 1 was unforeseen and 2 indicates that the research procedures caused harm to participants or others or indicates that participants or others are at increased risk of harm The harm does not have to be a direct harm to be reportable The harm as assessed by the PI or monitoring agent has presented increased risk e g losing a laptop with subject data Additionally the harm doesn t have to be the harm to subjects it could involve risk to others researchers technicians bystanders the public etc Note non medical events e g breach of confidentiality emotional breakdown loss of insurance etc if unanticipated
4. email to submissions compassirb com or fax this form to 480 832 7376
5. ntiality L Incarceration of a participant in a protocol not approved to enroll prisoners O Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research participant 0O Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team O Event that requires prompt reporting to the Sponsor E Sponsor imposed suspension for risk C Event that was not related or unexpected and meets no other reporting criteria noted above This does not have to be reported to the IRB but will be accepted and sent to file Event Identification Event date Subject Initials or Case if applicable Was the event study related Yes No Select one _ Initial report to IRB O Follow up If follow up please proceed to Document Attachments section whe rue COMPASS GUIDING YOU TO SUCCESS Event Details ae 5416 East Baseline Road Suite 120 Mesa AZ 85206 rT Phone 480 832 7373 or 877 660 1IRB Fax 480 832 7376 www compassitb com Briefly describe the circumstances of this event Classify the event e g pregnancy death adverse event life threatening prolonged hospitalization etc How long did the event last Do you plan to notify currently enrolled subjects of this event _ Yes L No Do you plan to notify completed subjects of this event _ Yes _ No If yes describe method of notification
6. ser s Manual O Yes O No If yes attached a redlined revision to the document eZ a r Z 5416 East Baseline Road Suite 120 Mesa AZ 85206 COMPASS DR Phone 480 832 7373 or 877 660 1IRB Fax 480 832 7376 GUIDING YOU TO SUCCESS www compassitb com Additional Information Is there any additional information you need to share with Compass IRB If yes please use this space to share with us I hereby certify that I have fully disclosed all information pertaining to this event and that the above referenced information is accurate Signature of Submitting Party Name Signature COMPASS IRB INTERNAL USE ONLY CIRB Staff ID Is this report appropriate for review Yes No If No please list reason that report is inappropriate for review e g does not meet definition of unanticipated problem incomplete report Decision of Reviewer Is this event an unanticipated problem that involves risk to participants or others Is there information in this report that involves an allegation of non compliance If yes must request a site audit and or send to Full Board LI No further action necessary L Request Audit L Request additional information L Send to Full Board L Call Site Sponsor for discussion Comments Notes as needed Signature of Board Reviewer If checked please attach all follow up documentation to this report and resubmit to Board Reviewer Please mail
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