Page 205 - eBook Version 8 Book 1 of 2 JUL 2022

Study Maintenance: Informed Consent, Participant
Screening & Enrollment, EPIC Orders, Study
Documentation, Adverse Events, and IRB Updates
Informed Consent
Have you verified that current IRB approved informed consent (IC) and HIPAA Authorization documents were used to consent the research participant?
For non-English speaking participants, was an interpreter (or unbiased witness) used during the informed consent process?
For each enrolled subject, was printed name, signature, and date/time obtained on the consent document from participant (parent/LAR and child) and the person obtaining consent?
For each consented subject, have all documents been reviewed to verify that patient labels are affixed to each page of the IC and HIPAA Authorization forms?
For each consented subject, was a copy of the fully executed IC and HIPAA Authorization provided to the participant/family? Were the original copies filed in the participant binder?
For each consented subject, has a copy of the fully executed IC and HIPAA Authorization been provided to Children’s Health Health Information Management (HIM) to scan and file in the participant’s EPIC medical record?
For each consented subject, has an informed consent process note been created in the participant’s EPIC record?
Participant Screening & Enrollment
Has each participant been entered on the study screening log? If not eligible, have the reasons for exclusion been identified and documented?
Has each participant been registered in Velos?
Has each participant’s status been updated in Velos and that status change is reflected in Children’s Health EPIC?
Has each enrolled participant’s status been updated on the study enrollment log?
EPIC Orders
Have orders been placed in EPIC for each study required intervention for a research participant (e.g., venipuncture, imaging, labs, etc.)? Detailed guidance for Ambulatory and Inpatient orders are available on LearnEpic.
Study Documentation
Has a research progress note been created for each participant visit in EPIC?
Has a research progress note been created for each participant encounter (e.g. telephone contact calls) in EPIC?
Adverse Events
Have all unanticipated problems been reported that meet IRB policy to the IRB of Record? Have all unanticipated problems been reported that meet Children’s Health policy to the
ResearchAdverseEvents@Childrens.com?
Has an eSET been created for all unusual incidents that occur on Children’s Health sites for research
participants, family, or staff?
IRB Updates
Have all study related updates pertaining to personnel, IC/HIPAA, protocol, IB, recruitment materials, target enrollment been submitted to and approved by the IRB before they are implemented?
Has continuing review been submitted to the IRB and granted annual approval?
Have all milestone updates (e.g. protocol deviation, protocol violation, sponsor reports, DSMB/DSMC reports, external adverse events that are related or possibly related) been reported and acknowledged by the IRB?
Have all requested updates approved by the IRB been appropriately filed in the regulatory binder and sent to the study sponsor?
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Version Date: 7/21/17