Subjects participating in DF/HCC clinical trials are registered in the OnCore Clinical Trial Management System.
DF/HCC Policies and Operations
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.
- Signed informed consent document
- Completed eligibility checklist* (with all required signatures per REGIST-100)
- Documentation of dose level or treatment arm assigned by an external sponsor, when applicable.
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 email@example.com and provide a compelling justification for ODQ's involvement. Requests will be considered on a case-by-case basis.
De-centralized registration refers to the process where study teams register participants directly into the OnCore CTMS. Requirements for de-centralized registration are outlined in REGIST-101 and the process is described in REGIST-OP-1.
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.
External Site Registrations (DF/HCC Investigator-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-100, 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.