PennCRMS

About

PennCRMS

The PennCRMS (Velos) is a clinical research management system designed to support and manage research in the Perelman School of Medicine (PSoM). This centralized database is designed to help study coordinators, principal investigators, faculty and research staff track and report on nearly every aspect of a clinical trial.

The PennCRMS enables the study team to manage aspects of research such as subject tracking, CRF collection, data management, reporting and financial tools. Study calendars can be created based on the protocol to track milestones. The benefits of this centralized management system include improved regulatory compliance, visibility into study status and study progress, study data aggregation and financial oversight. The PennCRMS interface with PennChart (EPIC) synchronizes patient enrollment statuses between the two systems, creating one consistent source of enrollment data. Study, patient, and demographic data remain current and accurate in both systems.

The information below outlines the training required for new accounts, reactivations, and those external to University of Pennsylvania. Access to the PennCRMS (Velos) requires training and may depend on your role or your previous access.

Please Note: PennCRMS account are deactivated after 6 months of inactivity. Log-in every 6 months to keep your account active.

PennCRMS Access: Coordinators, Research Assistants, Study Team Members, Project Managers

The PennCRMS Fundamentals Instructor-led Training is a synchronous virtual session, includes a hands-on training exercise and reviews the following workflows: study registration, study management, patient management/enrollment.
NOTE: This virtual training allows for 15 attendees and can be self-assigned. Access and Credit will be given after attending the entire class and completing the training exercise.

PennCRMS Access: PIs, Faculty, Residents, Fellows

Principal Investigators, Faculty, Residents and Fellows can choose from two online training modules based on their needs and use of the PennCRMS. Use the decision tree below to choose the appropriate training and the corresponding link to the course in Workday Learning.

Contact OCR's PennCRMS Team if you have any questions about the PennCRMS. Click on the appropriate link below to go directly to the training in Workday Learning.

-PennCRMS CRF Training: SAE Sign-off/PI Verification

-PennCRMS Fundamentals: PIs, Faculty, Residents, Fellows

Reactivating a PennCRMS Account

PennCRMS accounts are deactivated after 6 months of inactivity. If you have switched job roles and/or departments, this could impact your access and modifications to your account may be needed. To reactivate your PennCRMS account:

Submit a request to PennCRMS IT Support to have your account reactivated or via the PennCRMS Online Submission Form. Be sure to select “reactivate account” in your ticket category. A member of the PennCRMS team will contact you via your ticket outlining the requirements for reactivation.
- Account deactivated 6-12 months
  - Access form required
- Account deactivated 12-24 months
  - Access form required
  - PennCRMS Refresher required
  - Submit a ticket to the PennCRMS IT Support team ticket indicating training refresher is completed. If you have not submitted your PennCRMS access form, attach it to this ticket.
- Account deactivated 24+ months
  - Access form required
  - In-person training is required. Self-registration is via Workday

PennCRMS Advanced Training (CRFs, calendars and data extraction)

OCR offers training classes on advanced functions of the PennCRMS such as building calendars or case report form (eCRFs). Submit a PennCRMS IT Support ticket to request this training.
Please Note: You should have an active PennCRMS account to request this training.

External PennCRMS Access (non-Penn staff)

A Penn staff member “sponsoring” the external user should submit a request for guest PennKey here
Once the guest PennKey has been assigned, a WorkDay Learning account will also be created
If the user is unable to log into Workday:
- Email psom-ocrops@pobox.upenn.edu and request that the user is activated.
- OR you can self- activate using this Workday tipsheet
Users can now self-enroll into the PennCRMS Fundamentals Training: Instructor-led class (Virtual)

PennCRMS Links to System

PennCRMS Training/Sandbox link

For testing and training

PennCRMS Live/Production link

For data entry and study management

PennCRMS User Manuals

PennCRMS User Manual: Study Registration

Comprehensive guide to registering studies and study administration

PennCRMS User Manual: Study Management

Comprehensive guide to managing study statuses, study teams, study set up including calendars

PennCRMS User Manual: Subject Management

Comprehensive guide to managing subject statuses, status definitions

PennCRMS Support

PennCRMS FAQ

PennCRMS Policy Documents & Release Notes

Study Management

PennCRMS: Managing Study Site Status

Manage study site statuses, study start/end date, and current status

PennCRMS: Managing Study Teams

Adding study team members, manage access rights, and deactivating team members

Subject Management

Creating New Patients/Subjects in the Penn Participant Organization (Penn Medicine Staff)

Creating a participant record is reserved only for studies that are not utilizing PennChart/EPIC services and/or are not collecting enough identifiable information to locate the record in CRMS.
This process requires account modifications and should begin with a ticket request to PennCRMS IT Support.

Creating a Patient/Subject on Behalf of an External Organization (Penn Medicine Staff)

Creating a patient/subject record within an external organization (Penn Staff)
Account modifications are needed to create within external organizations

Creating a Patient/Subject in External Organizations (Non-Penn Medicine Staff)

Creating patient/subject records in your external organization (non-Penn Medicine staff only)

Subject Status Flow Chart

Recommended workflow for subject statuses

Adding a New Organization & Updating Enrolling Facility

PennCRMS /PennChart

Epic Billing Review/PennCRMS Subject Status

For synchronized studies where the status is updated in either system:

-How the other system is impacted

-How to use status or dates to control billing review in EPIC

Locating a UID/MRN in PennChart