Topics Map > OnCore > Data Field Definitions
OnCore: DFD - Protocol Staff Role
| Protocol Role | Definition | Requirement Entry Instructions |
Mapped to Florence | Mapped to Health Link |
|---|---|---|---|---|
| Affiliate Site Principal Investigator | Responsible investigator at the affiliate site for the conduct of the research study. | Required for situations described; multi-site research | Not mapped | Not mapped |
| Affiliate Site Study Coordinator | Provide coordination and management of the research study at the affiliate site for the activities associated with subject enrollment and participation. | Required for situations described; multi-site research | Not mapped | Not mapped |
| Affiliate Sub-Investigator | An investigator at the affiliate site who provides a significant contribution and assistance to the principal investigator in the conduct of the research study. | Not required | Not mapped | Not mapped |
| Biobank | Biobank is listed if the Translational Science BioCore (TSB) is a collaborator on the protocol (fresh or flash frozen tissue is collected). | Required for situations described; ancillary services for notifications | Not mapped | Not mapped |
| Cancer Pharmacology Laboratory | Cancer Pharmacology Laboratory is listed if CP Lab is a collaborator on the protocol. | Required for situations described; ancillary services for notifications | Not mapped | Not mapped |
| Clinical Research Unit (CRU) | Clinical Research Unit (CRU) is listed if the CRU is a collaborator on the protocol. | Required for situations described; ancillary services for notifications | Not mapped | Not mapped |
| Collaborator | Individual collaborators who provide ePRMS Collaborator Signoff for UWCCC Protocol Review and Monitoring Committee (PRMC) submissions. | Required for situations described; refer to ePRMS Submission OnCore Tutorial for instructions. | Not mapped | Not mapped |
| Compliance and Monitoring Coordinator | Personnel responsible for monitoring and auditing clinical research studies to ensure compliance with federal regulations, state and local laws, and applicable controlled documents.
Provides administrative support for the UWCCC Data and Safety Monitoring System (DSMS), including the Data and Safety Monitoring Committee (DSMC). |
Not Required | Mapped to Internal Compliance DSMC Coordinator | Not mapped |
| Contract Specialist | The staff member involved in drafting and negotiating the contract and budget for the study. | Required in situations with central contract negotiation separate from other financial roles (e.g., CTI, DoM) | Not mapped | Not mapped |
| CRIC Imaging | Radiology imaging support related to oncology research. | Required for situations described; ancillary services for notifications | Not mapped | Not mapped |
| Data Analyst | Personnel responsible to provide analysis of study data. | Not Required | Not mapped | Not mapped |
| Data Coordinator | Personnel responsible for managing subject data, coordinating sponsor/monitor visits and supporting study coordination tasks. | Not Required | Mapped to Study Coordinator | Not mapped |
| Data Manager | Provide oversight of data collection for accuracy and legitimacy of data. | Not Required | Mapped to Study Coordinator | Not mapped |
| Fellow/Trainee | Fellow or MD-in-training who assists in the conduct of the research study. | Not Required | Mapped to Study Investigator | Not mapped |
| Financial Specialist | Personnel responsible for the financial aspects of the research study, including invoicing and reconciling accounts. | Required if using OnCore financial functionality | Not mapped | Not mapped |
| Imaging Staff | Personnel responsible for performing ophthalmologic imaging data collection. | Not required | Not mapped | Not mapped |
| Monitor | Internal UW personnel who observe and check the progress or quality of (something) over a period of time; keep under systematic review. | Required if using internal UW personnel outside of the study team for monitoring | Not mapped | Not mapped |
| Multisite Coordinator | UW staff responsible for coordination with non-UW sites when UW is the coordinating center on a multi-site study | Required for situations described | Mapped to Regulatory Staff | Not mapped |
| Office for Translational Research Services | OTRS is listed if UWCCC OTRS is involved in the protocol (e.g., IND/FDA annual report submission services) or if it is a WONIX study. | Required for situations described | Not mapped | Not mapped |
| Outreach/Recruitment Coordinator | Conduct outreach and recruitment activities for the research study. | Not Required | Not mapped | Not mapped |
| Pathology | Pathology is listed if UW Pathology is a collaborator on a UWCCC protocol. | Required for situations described; ancillary services for notifications | Not mapped | Not mapped |
| Pharmaceutical Research Center | PRC is listed if PRC is a collaborator on the protocol (drug or agent is involved in the protocol). | Required for situations described; ancillary services for notifications.
Note: Not used for studies that are open to affiliate sites only. |
Not mapped | Not mapped |
| Primary Budget Contract | Provide main coordination for the financial aspects of the research study.
Limited to one member of the study team. |
Not Required | Not mapped | Not mapped |
| Primary Regulatory Contact |
Provide main coordination of the IRB and/or FDA application(s) or the development of the research protocol and informed consent document(s) for the research study. Limited to one member of the study team. |
Required | Mapped to Regulatory Staff | Not mapped |
| Primary Study Coordinator |
Provide main coordination and management of the research study for the activities associated with subject enrollment and participation. Limited to one member of the study team. |
Not Required |
Mapped to Study Coordinator | Health Link Research Activity access |
| Principal Investigator |
Responsible investigator for the conduct of the research study |
Required |
Mapped to Study Investigator | Health Link Research Activity access |
| Program Manager |
Manage the research program for which the research study is conducted. For UWCCC, this is either the Program Manager or Pod Manager. |
Required for oncology | Mapped to Study Coordinator | Health Link Research Activity access |
| Protocol Administrative Coordinator |
Staff responsible for coordinating and overseeing activities and administrative tasks related to clinical research study activation and maintenance. |
Not Required | Mapped to Study Coordinator | Not Mapped |
| Protocol Coordinator |
Research staff responsible for administrative tasks related to protocol activation and maintenance such as protocol review and workflow development. |
Required for non-oncology | Mapped to Regulatory Staff | Not Mapped |
| Protocol Creator |
User who created the protocol; included automatically in OnCore protocol staff list when protocol is created. |
Default | Not Mapped | Not Mapped |
| Radiology |
Radiology is listed if UW Radiology is a collaborator on the protocol. |
Not Required | Not Mapped |
Not Mapped |
| Rater/Coder/Evaluator |
Staff responsible for administering and/or scoring cognitive tests or other evaluative measures. |
Not Required | Not Mapped |
Not Mapped |
| Regulatory Coordinator |
Provide coordination of the IRB and/or FDA application(s) or the development of the research protocol and informed consent document(s) for the research study. |
Not Required | Mapped to Regulatory Staff | Not Mapped |
| Research Administrator |
Administration of the research program for which the research study is conducted. |
Not Required | Mapped to Regulatory Staff | Not Mapped |
| Research Billing Contact |
Responsible reviewer of research charges in Health Link. |
Required if the study has UWH billing | Not Mapped | Health Link Research Activity access |
| Research Lab Staff |
Provide laboratory support, processing and/or analysis of biological specimens for the research study. |
Not Required | Not Mapped |
Not Mapped |
| Research Nurse |
Research Staff with a nursing degree or designation who consents subjects, completes regulatory tasks, and/or performs other duties for research studies. |
Not Required | Mapped to Study Coordinator | Not Mapped |
| Statistician |
UW Statistician who conducts statistical analysis of the collected data for the research study. |
Required in oncology if applicable: ePRMS signoff | Mapped to Study Investigator | Not Mapped |
| Study Chair |
Staff responsible for providing overall management for the operation of the study, and for reporting to the Data and Safety Monitoring Board. |
Required for oncology | Not Mapped | Not Mapped |
| Study Coordinator |
Provide coordination and management of the research study for the activities associated with subject enrollment and participation. |
Required | Mapped to Study Coordinator | Health Link Research Activity access |
| Study Finder Contact |
The email associated with this listing will be available on Study Finder for potential participants to contact. |
Required for non-oncology in the situations described: using Study Finder | Not Mapped | Not Mapped |
| Sub-Investigator |
An investigator who assists the principal investigator in the conduct of the research study. |
Not Required |
Mapped to Study Investigator | Health Link Research Activity access |
| Submitter |
The study staff responsible for submitting the protocol to the PRMC via ePRMS. |
Required for oncology |
Not Mapped | Not Mapped |
| TRIP Lab |
TRIP Lab is listed if the UWCCC TRIP Lab is involved in the protocol. |
Required for oncology in the situations described: ancillary services for notifications |
Not Mapped | Not Mapped |
| UWCCC Network Facilitator |
UWCCC Network Facilitator is listed if CRCO Network Coordinator coordinates affiliate study activities. |
Required for situations described in oncology |
Not Mapped | Not Mapped |
| UW Enrolling Provider/Faculty |
The physician or other provider who enrolled the participant(s) in the study. |
Required for oncology |
Not Mapped | Not Mapped |
| UW Referring Provider |
The physician or other provider who initiates the trial discussion then refers the subject to the study team and/or UW Enrolling Provider for enrollment. |
Not Required. Used to track internal referrals for treatment trials. Enter if applicable and known. |
Not Mapped | Not Mapped |