AUNM | ilisilt nse bo Standard Operating Procedures SOP #0510] TE Reporting of Preto Devitions eve at vtion0 ons/ars Faproved By] Sare tate omoowecer | ey “cee fot be fiom Tae Bag — Ome ito cat LZ ye PURPOSE ‘To describe th policies and procedures for researcher reporting of minor protocol deviations REVISIONS FROM PREVIOUS VERSION None Poucy Federal regulations require the IRB to review and approve proposed changes to research stuies before Intation ofthese changes, except when changes are “necessary to eliminate apparent immediate hazards tothe subject” (45 CFR 46.103(b\4Nil)). Most proposed changes are reviewed through submission of amendments. Any changes that are made to eliminate apparent immediate hazards toa Participant should be reported as soon as possible after they accu asa protocol deviation. Deviations range in seriousness according to how the changes may impact subject safety, the degree of ‘noncompliance with federal and state regulations, and the degree of foreknowledge ofthe event. Deviations must be reportedto the IB witha description ofthe deviation, its impact on participant safety fan) and a description of how similar events willbe avoided inthe future. Once reported, the Ine can make a decision regarding an appropriate response of remedial action, Remedial actions may Involve excluding data that vas obtained inappropriately ora recommendation for alitional ‘monitoring of study procedures. Note that repeated deviations ofthe same type may be an indication that an amendments needed to permanently change study criteria ‘Maj protocol violations (involve risks) ‘Aceldental or unintentional protocol violations thet involve sks to parties ur uthers nt be ‘reported tothe IRB accordingto the IRB SOP 401 ~ Reporting and Review af Events Involving Risks to Participants or Others A major violation is ane that may impact participant safety or ater the Fisk/benent rato, compromise the integrity of the study data, and/or alec participants’ willingness to participate inthe study. Majo: violations require prompt reporting and should be eparted to the IRB within 7 calendar days ofthe researchers knowledge ofthe deviation. Reports should be made sing ‘the Event Form, Page 1 of2NUNM | itr tant [Minor protocol deviations (involve no risks) Minor or administrative protocol deviations are defined as a one-time deviation from the IRB-approved protocol that involve no risks to subjects a athers, A minor deviation is one that does not impact participant safety, compromise the integrity ofthe study data, or affect participants wilingness to Partcpate i te stugy. Examples of minor or adminstrative deviations could include: ‘Missing pages of signed consent form {inappropriate documentation of informed consent, including: ‘© missing esencher signature andor date; copy not given to the person signing the form, {© someone other than th participant dated the consent form; © individual otainng informed consent not listed on IRB approved project team st. “+ Use of invalid consent frm, ie, consent form without IB approval stamp or outdated/expired ‘consent form; ‘+ Fallare to follow the approved study procedure that, In the opinion of the P, does not affect subject safety or data integrity > Study procedure conducted out of sequence; (Omitting an approved portion ofthe protocol; Failure to perform a required lb test Enrollment ef neigibe subject. partiipant's age was 6 months above age lint); Stuy procedure conducted outside of required timeframe; + Overenrallment. [RESPONSIBILITIES Execution of SOP: Researches. PROCEDURE Researcher Reporting Requirements for Minor Protocol Deviations 1. Members of the research team must immediately report the occurrence of protocol deviation to the Principal Investigator PD 2. Allminor deviations shouldbe recorded by the research team and summarized for the IRB at the time of continuing review using the Protocol Deviations Report (available on the OIRB website and ‘ener, 3. Additional reporting requirements to federal agencies, study sponsor, or other entities also may be required as determined by the PL 4. The IRB may request mote stringent requirement for reporting protocol deviations fr invidual researc studlesifit is deemed necessary. REFERENCES 45 CFR 46.103(5)(5) Page 2012