| 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.
- Manual: Used for any manual associated with the protocol (E.g. lab manual, pharmacy manual, pathology manual, imaging manual). If a pathology manual is available, and pathology is a collaborator, it must be uploaded here.
- 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 |
