Topics Map > OnCore > Data Field Definitions > Non-oncology

Document Type

Field Name Definition Requirement
Entry Instructions
QA
Type Indicates the type of regulatory document being reviewed at the IRB meeting:
Protocol: Select Protocol for protocols and amendments.
Consents: Select the following:
  • Main Study Consent: Primary Study Consent without HIPAA authorization language embedded into the document.
  • Combined Main Study Consent/HIPAA Auth: Primary Study Consent document with HIPAA authorization language embedded into the document.
  • Sub-Study Consent: Consent without embedded HIPAA authorization language utilized for sub-studies embedded within the main study that share the main study protocol number. Example: Prescreening, optional biomarker, treatment beyond progression, pregnancy.
  • Combined Sub-Study Consent/HIPAA Auth: Consent with embedded HIPAA authorization language utilized for sub-studies embedded within the main study that share the main study protocol number. Example: Prescreening, optional biomarker, treatment beyond progression, pregnancy.
  • Donor Consent: Utilized for transplant studies, e.g., bone marrow, kidney, etc.
  • Assent: Utilized for children under 18 years of age and adults with compromised mental capacity.

HIPAA Authorization: Standalone UW authorization for the sharing of subject personal health information.
Investigational Drug/Device Brochure (IDB): Required if an IDB is involved in the study.
External Institution(s): Use when submitting any affiliate-related information, local reviews, and/or documents to the UW-IRB.
Reportable Event: Unanticipated problems, noncompliance, and/or new information.
Outside Safety Reports (OSR): External safety letters.
Subject Communication: Any document intended for the patient or subject, e.g.,subject information sheets, medical instruction sheets, medication diaries, etc.
Public Communication: Any document intended for the public at large, e.g., recruitment materials, website content, etc.
Sponsor Communications: Any documents from the study sponsor, e.g., letters from the sponsor or protocol notices, etc.
Required
Entry of Type must be consistent in order to replace a previous version. If a new version of a Consent Type needs to be documented, be sure to select the same Type as originally entered.
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Keywords:Type Document Review IRB   Doc ID:101862
Owner:Molly L.Group:SMPH Research Informatics
Created:2020-05-08 09:59 CSTUpdated:2022-10-05 09:09 CST
Sites:Institute for Clinical and Translational Research, SMPH Research Informatics
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