Page 296 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Study Maintenance: Informed Consent, Participant Screening & Enrollment, EPIC Orders, Study Documentation, Adverse Events, and IRB Updates
Informed Consent
Select
Comments
Have you verified that current IRB approved informed consent (IC) and HIPAA Authorization documents were used to consent the research participant?
Yes No
For non-English speaking participants, was an interpreter (or unbiased witness) used during the informed consent process?
Yes No
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?
Yes No
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?
Yes No
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?
Yes No
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?
Yes No
Yes No
Participant Screening & Enrollment
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Comments
Has each participant been entered on the study screening log? If not eligible, have the reasons for exclusion been identified and documented?
Yes No
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?
Yes No
Yes No
Has each enrolled participant’s status been updated on the study enrollment log?
Yes No
EPIC Orders
Select
Comments
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.
Yes No
Study Documentation
Has a research progress note been created for each participant visit in EPIC?
Yes No
Has a research progress note been created for each participant encounter (e.g. telephone contact calls) in EPIC?
Yes No
Adverse Events
Have all unanticipated problems been reported that meet IRB policy to the IRB of Record?
Yes No
Have all unanticipated problems been reported that meet Children’s Health policy to the
ResearchAdverseEvents@Childrens.com?
Yes No
Has an eSET been created for all unusual incidents that occur on Children’s Health sites for research participants, family, or staff?
Yes No
IRB Updates
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Comments
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?
Yes No
Yes No
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?
Yes No
Have all requested updates approved by the IRB been appropriately filed in the regulatory binder and sent to the study sponsor?
Yes No
Version Date: 7/21/17