Subjects participating in DF/HCC clinical trials are registered in the OnCore Clinical Trial Management System. Registration occurs via either a Centralized or De-Centralized process.
For more information, please contact us at ODQ@dfci.harvard.edu.
Forms and Templates
Policies and SOPs
Centralized registration refers to the process where study teams submit registration materials and ODQ performs the actual registration into the OnCore CTMS. Centralized registration is currently required for all trials randomized by ODQ.
A handful of other teams and trial types continue to use the centralized registration process; however, most of these groups will transition to the de-centralized process in the near future. If you are unsure whether a protocol requires centralized registration, please consult with your research manager prior to contacting ODQ.
In accordance with REGIST-101A, please submit the following to ODQ in order to register a subject in OnCore:
- Signed informed consent document
- Completed eligibility checklist* (with all required signatures per REGIST-104)
- Documentation of dose level or treatment arm assigned by an external sponsor, when applicable.
* For protocols that do not require an eligibility checklist, please use the generic Protocol Registration Form.
De-centralized registration refers to the process where study teams register participants directly into the OnCore CTMS. This process is described in REGIST-101B.
Most registrations within the DF/HCC (>85%) follow the de-centralized process. However, centralized registration is currently required for all trials randomized by ODQ. If you are unsure which registration process to follow, please consult with your research manager prior to contacting ODQ.
ODQ performs randomization for investigator-sponsored therapeutic trials that register subjects in OnCore according to REGIST-101A.
For non-therapeutic protocols, study teams may opt to perform randomization themselves for expediency and continuity. This offers a couple of advantages:
- Quicker turnaround on registration confirmations.
- Ability to randomize subjects during non-business hours or holidays when ODQ is unavailable for randomization.
To request that ODQ facilitate randomization on non-therapeutic protocols, please email firstname.lastname@example.org and provide a compelling justification for ODQ's involvement. Requests will be considered on a case-by-case basis.
External Site Registrations (DF/HCC-Sponsored, Multi-Center Trials)
External sites accruing participants to DF/HCC investigator-sponsored, multi-center clinical trials must follow the registration process outlined in the protocol and data safety monitoring plan.
In general, the registration process for external site participants includes the following steps:
- The external site obtains informed consent and screens the participant for eligibility.
- An appropriately delegated and qualified individual at the external site signs off as screening staff on the eligibility checklist.
- The external site sends the completed eligibility checklist and signed informed consent document to the DF/HCC coordinating center.
- When required per REGIST-104, an enrollment monitor at the coordinating center must verify participant eligibility and sign the eligibility checklist.
- The DF/HCC coordinating center is responsible for registering the subject in OnCore (de-centralized), or sending the registration packet to ODQ (centralized).
- The DF/HCC coordinating center will forward registration confirmation to the external site.
- The external site must notify the coordinating center of subject status changes (off treatment, off study).
- The DF/HCC coordinating center is responsible for updating the subject status in OnCore (de-centralized), or notifying ODQ (centralized).
A protocol-specific eligibility checklist is required for protocols that have inclusion and/or exclusion criteria and register subjects into OnCore.
Subject Status - Off Treatment / Off Study
The subject status needs to be updated in OnCore when a subject comes off treatment or off study.
Under the de-centralized registration process, study teams are responsible for updating the subject status in OnCore directly. For more information, please review the Off Study/Off Treatment Quick Guide within the OnCore WIKI.
Occasionally, subjects will transfer to or from an external (non-DF/HCC) institution or within DF/HCC institutions. This must be recorded in OnCore.
Please complete a Subject Transfer Form and follow the procedures outlined in REGIST-103 to transfer a subject between institutions. Once the subject is transferred, please review the Subject Transfer Guidance to ensure OnCore is updated appropriately.
Duplicate Enrollment / Replacements / Co-Enrollment
The OnCore CTMS has controls in place to prevent co-enrollment to more than one therapeutic protocol, and to prevent duplicate registrations.
In exceptional cases, ODQ can assist with overriding these controls to allow co-enrollment or re-registration. Please see here for more information: OnCore Guidance: Registration Safety Mechanisms and Exceptions.
If the protocol allows for subject replacement, please follow the Procedures for Subject Replacement.