OnCore is the Clinical Research Management System (CRMS) developed by Advarra Research Systems that supports clinical research activities at Duke and allows for enhanced clinical research study management, robust reporting, enrollment tracking, and accurate clinical research billing.
eReg is an electronic regulatory binder developed by Advarra Research Systems that interfaces with OnCore.
Training is required for all users to gain access to either system.
Content from the Duke Office of Clinical Research is now live on myRESEARCHpath! Current DOCR content can also be found there.
Obtaining access to OnCore is a two-step process: first, complete the required training and then submit a ServiceNow ticket to request access.
Step 1
Required OnCore Courses
Each employee whose job duties require access to OnCore must complete the designated training for the appropriate functional role(s) before access is granted.
If more than one role is performed, the employee must take the training for each role. A common example is for staff that function as both a clinical research coordinator and a regulatory coordinator. For that staff member, both subject management and protocol management courses are required.
|
Role |
Course Name and Description | Link |
|---|---|---|
| Required for all roles |
OnCore Basic Navigation: This online course is a prerequisite for all OnCore Training courses and consists of two learning modules. Participants will be able to recognize and recall basic navigation functions within OnCore. |
Register |
| Subject Management (Clinical Research Coordinators) | OnCore Training for the Clinical Research Coordinator: This online training course is required for staff who will be registering participants and tracking study visits. | Register |
|
Protocol Management (Regulatory Coordinators) |
OnCore Training for the Regulatory Coordinator: This online training course is required for staff who will be updating protocol information, including adding the minimum footprint requirements. |
Register |
| OnCore Financials (Finance Practice Managers (FPMs), Financial Analysts) | Contact SOMFClinicalResearch@dm.duke.edu to discuss training requirements and the process for obtaining access. | |
| CRU Leadership (CRU Director, RPM, ARPM) |
CRU Leadership Essentials in OnCore: This online training is relevant for CRU leadership, such as the CRU Director, RPM, ARPM, etc., who need OnCore access to all protocols across a clinical research unit. This course focuses on administrative and reporting functions in OnCore. |
Register |
|
Duke Administration (Dean, Assistant Dean, Chairmen) |
Administrative Leadership Essentials in OnCore: This online training course is for administrative leadership in Duke SoM who need organizational access across CRUs into OnCore (Dean, Assistant Dean, Chairmen, Business Managers, etc.). This course focuses on administrative and reporting functions in OnCore. |
Register |
|
Principal Investigators |
Principal Investigator Essentials in OnCore: This online training course provides an overview of OnCore for Principal Investigators. Participants will be able to recognize and recall basic navigation to the PI Console and Reports sections of the OnCore system for study management.
Note: Investigator’s who need to enroll subjects in OnCore should also take the Subject Management course, OnCore Training for the Clinical Research Coordinator. |
Register |
| Additional Training | Description | Link |
|---|---|---|
| OnCore Training: Using the SIP Console - DOCR | This online training course will review the steps required for working with the Recruitment Innovation Center (RIC) in order to have a study posted on the Duke Health Clinical Trials Directory. Information entered into the SIP (Study Information Portal) console in OnCore is pushed to the dukehealth.org website where the community can easily search for available research studies. | Register |
| OnCore 150: Randomization and Stratification Recorded Webinar | This recorded webinar will discuss how to use Randomization Blocks, Stratified Blocks, and OnCore's Randomization Algorithm for subject accruals in OnCore. This course is intended for statisticians and other study personnel who want to manage this functionality for Investigator-Initiated randomized studies in OnCore. | Register |
| Subject Visit Tracking in OnCore - DOCR | This micro-learning video will provide updated instructions for completion of the Subject Visit Update Screen, help you understand the impact of subject visit tracking on OnCore Financials, and review best practices and their importance in avoiding critical billing errors. | Register |
| OnCore Microlearning Video Library | This WarpWire library houses short videos to help clinical research staff with specific functions in OnCore. Any OnCore videos created for training purposes will be added to this library. | Link |
Step 2
Submit an Access Request to Create an OnCore Account
After you have completed the training for your role(s), submit an Account Access Order form in ServiceNow to request OnCore access. To submit a ticket please click here.
Under the "Enterprise Services" section, select OnCore - CRMS.
On the second page, choose your CRU and check the requested role(s).
The ServiceNow ticket will be routed to your Manager for approval. After your manager signs off on the ServiceNow ticket, OASIS will confirm your training has been completed and create your account. Follow the link within the email to set up your account.
Add/Change/Deactivate Access
To add, change, or deactivate access to OnCore, use the same Account Access Order Guide form as above, but choose "Change" or "Deactivate" as the Type of Request. The ServiceNow ticket will be routed to your Manager for approval.
Content from the Duke Office of Clinical Research is now live on myRESEARCHpath! Current DOCR content can also be found there.
Obtaining access to eReg is a two-step process: first, complete the required training and then submit a ServiceNow ticket to request access.
Step 1
Required eReg Courses
eReg is a Part 11 compliant, electronic Regulatory Management System that allows regulatory coordinators to store protocol documents, track staff credentials and organizational regulatory documents, and share those documents between protocols. Staff can also manage INDs, SOPs, and subject-related documents within the system. eReg also allows for remote monitoring.
All staff and monitors who will log into eReg to sign, view, or manage documents will need an eReg account.
If more than one role is performed, the employee must take the training for each role. A common example is for staff that manage both regulatory and subject-related documents. For that staff member, both Regulatory Coordinator and Subject Access courses are required.
| Role | Course Name and Description | Link |
|---|---|---|
|
Signer Study staff who only need to electronically sign documents in the system (PIs, Sub-Is, coordinators, data managers, etc.) |
eReg for PIs and Protocol Staff: Anyone who needs to sign training, protocol, or delegation of authority documents will need to take this brief training. This role allows the user to electronically sign documents and provides view-only access to study binders when the user is listed on the binder’s staff list. Accounts are automatically set up on a weekly basis for anyone who has taken training during the previous week. If you need an account set up sooner, submit a ServiceNow ticket. Select the “Signer” role when requesting an eReg account. |
Register |
| Regulatory Coordinators | eReg Training for the Regulatory Coordinator: This online training curriculum is required for anyone who will need to manage the regulatory binder, add documents and route them for signature. | Register |
|
Regulatory Manager (RPM/ARPM/RPL) |
eReg Regulatory Manager Role: The Regulatory Manager role is an administrative role that has access to all their CRU’s studies in eReg and does not need to be on the staff list in order to edit protocol binders and review sessions in their CRU. Because of this global access, this role is limited to RPMs, ARPMs, or RPLs who will be actively managing content in eReg. Note: Regulatory Managers also need to take the eReg for the Regulatory Coordinator course to get the Regulatory Manager role in eReg |
Register |
| Subject Access | eReg Subject Access Role: All staff who need to manage documents in the Subject binder will need to complete this training. Only users with the Subject Access role can access subjects and subject documents in the protocol binder and review sessions. | Register |
| Protocol Importer | eReg Protocol Importer Role: The Duke Protocol Importer role is an administrative role that has the permissions to import studies from OnCore into eReg and add the template for the protocol binder. This is an add-on role for Regulatory Coordinators and Regulatory Managers approved by their RPM or ARPM.. | Register |
| Reviewer | Reviewers are internal or external monitors/auditors that can view documents within eReg Review Sessions to which they are assigned. Regulatory Coordinators should follow the steps in the Setting Up Monitor Access to eReg tip sheet to establish eReg access for monitors. Reviewer access requires a Net ID, training, and an active eReg account. | LMS Training is not required |
Step 2
Submit an Access Request to Create a New eReg Account
After you have completed the training for your role(s), submit an Account Access Order form in ServiceNow to request eReg access. To submit a ticket please click here.
Note: The Signer and Reviewer roles do not require Manager Approval. The requestor may enter their name as the Approving Manager when requesting an account on behalf of a signer or reviewer.
Under the "Enterprise Services" section, select eReg Binder - Advarra.
On the second page, choose your CRU and check the requested role(s).
The ServiceNow ticket will be routed to your Manager for approval. After your manager signs off on the ServiceNow ticket, OASIS will confirm your training has been completed and create your account. You will receive an email with an activation link when your account has been created. The link will remain active for 10 days.
Add/Change/Deactivate Access
To add, change, or deactivate access to eReg, use the same Account Access Order Guide form as above, but choose "Change" or "Deactivate" as the Type of Request. The ServiceNow ticket will be routed to your Manager for approval.
Changing CRUs: Those with an eReg Importer, Reg Coordinator and/or Reg Manager user role will need to submit an Account Access change request in order to maintain their same level of access in their new CRU.
Content from the Duke Office of Clinical Research is now live on myRESEARCHpath! Current DOCR content can also be found there.
All OnCore tip sheets can now be found on myRESEARCHpath under the topics: manage study and maintain institutional approvals, manage research participants, prepare for institutional approvals, access research-related systems and applications, and elsewhere.
OnCore Tipsheets
- Basic Navigation
- Protocol Management (Regulatory Coordinator)
- Subject Management (Clinical Research Coordinator)
- Leadership
- Financial Staff
- Reporting
- Scorecard
- OnCore Upgrade Information
eReg Tipsheets
OnCore Deep Dives and Refresher Sessions
For general questions about how or when to use OnCore:
- the first point of contact is your RPM or ARPM. Some CRU’s may have designated OnCore Champions.
- You can also email OnCore@dm.duke.edu to create a ServiceNow ticket that will go to the DOCR OnCore/eReg support team.
- Please note: please do not use the email address if you need to send a secure email. Send secure emails cannot be opened from ServiceNow.
- Click here to request OnCore and eReg binder support through ServiceNow
- Include PHI in the Sensitive Information (PHI) Box.
If an OnCore calendar needs to be updated:
- If the changes are a result of a protocol amendment, you will be directed to complete a REDCap form during the amendment submission process in iRIS. Once that form is completed, DOCR Start-up will review the study for changes.
- For other changes, submit a Service Now ticket via the Maestro Care Research request form.
- Click here to submit a Maestro Care for Research ticket via ServiceNow.
- Select the subcategory: "Changes to research study order sets, treatment plans and/or billing calendars in the request form." The ticket will be routed to the DOCR Start-up team.
For questions about Oncore Financials, please email SOMFClinicalResearch@dm.duke.edu.
For questions about eReg, please email OnCore@dm.duke.edu to create a ServiceNow ticket that will go to the DOCR OnCore/eReg support team.
For questions about training: If you experience difficulties with the LMS training or have any questions related to your training requirements, please contact docr.help@dm.duke.edu.
To request access to OnCore: Submit a ServiceNow Accounts & Access request. Refer to the instructions under the OnCore Training and Access section.
OnCore Microlearning Videos
This WarpWire library houses short videos to help clinical research staff with specific functions in OnCore. Any OnCore videos created for training purposes will be added to this library.