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:
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. |
No |