Subject Registration

Subjects participating in DF/HCC clinical trials are registered in the OnCore Clinical Trial Management System.

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DF/HCC Policies and Operations

Centralized Registration

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-101 and REGIST-OP-1, 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-100)
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 in accordance with REGIST-OP-1.

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Randomization

ODQ performs randomization for investigator-sponsored treatment trials that register subjects in OnCore according to REGIST-101.

For non-treatment 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-treatment protocols, please email odq@partners.org and provide a compelling justification for ODQ's involvement. Requests will be considered on a case-by-case basis.

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De-Centralized Registration

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.

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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.

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Eligibility Checklist FAQs

Please see REGIST-OP-3: Eligibility Checklist Development, as well as the Eligibility Checklists tab on the Feasibility and Activation page, for information on the creation of eligibility checklists.
If registration is performed centrally by ODQ, please submit a completed Protocol Registration Form and the signed consent form according to REGIST-OP-1. Procedures for decentralized protocols are also outlined in this operation.
Please see REGIST-100 for a definition of Screening Staff and Enrollment Monitor, and information on when an Enrollment Monitor is required.
Note: Institutional policies may differ as to who can be the Enrollment Monitor and when an Enrollment Monitor is required. Please consult your institutional Clinical Trials Office for more information.
The DF/HCC requires a physician investigator to sign as the Screening Staff in order for the completed checklist to be considered source documentation for eligibility criteria that require clinical judgment and/or interpretation of a subject’s medical history and screening results (e.g., performance status, life expectancy, clinical staging).
Note: Institutional policies may differ as to the use of the eligibility checklist as a source document. Please contact your institutional Clinical Trials Office for details.
Screening Staff may choose to make notations in blank spaces or margins. If the eligibility checklist is being used as source documentation, the Screening Staff must comply with applicable DF/HCC policy (DOC-100) when completing the eligibility checklist.
Applicable boxes should always be checked in order to document each criterion was reviewed. Checking each box indicates that the subject is eligible (i.e., meets the inclusion criteria, does not meet the exclusion criterion).
This field captures the On Treatment date that will be entered into OnCore when the subject is registered. For treatment-based studies, the On Treatment date is the date treatment is schedule to begin.
However, for non-treatment protocols, there is no separate start of treatment date. Therefore, the On Study date is entered in OnCore for these types of studies. For more information, please consult the OnCore WIKI.

Subject Registration

Study teams are responsible for updating the subject status in OnCore directly for all trials, including for studies where the initial subject registration is performed centrally by ODQ. For more information, please review the Off Study/Off Treatment Quick Guide within the OnCore WIKI.
Subject transfers can occur when another IRB-approved institution accepts responsibility for the care of that subject in the conduct of a clinical trial. Please complete a Subject Transfer Form and follow the procedures outlined in REGIST-OP-1 to transfer a subject between institutions. Once the subject is transferred, please review the Subject Transfer Guidance to ensure OnCore is updated appropriately.
OnCore allows a subject to be registered to more than one protocol concurrently. However, there are safety mechanisms in place that prevent a subject from being "on treatment" on more than one treatment-based protocol at a time. This safety mechanism will also prevent a subject from being "on treatment" for both a treatment-based clinical trial and a treatment plan.
ODQ can assist with bypassing these safety mechanisms when appropriate. Please see here for more information: OnCore Guidance: Registration Safety Mechanisms and Exceptions.
Most protocols do not allow for subject replacement. However, if the protocol allows for subject replacement, please submit a Subject Replacement Request to ODQ and wait for approval before you attempt to register a replacement subject.
Most protocols do not allow for re-registration. OnCore will block attempts to re-register subjects on these protocols in order to prevent erroneous duplicate registrations.
ODQ can assist with bypassing these safety mechanisms when appropriate. Please see here for more information: OnCore Guidance: Registration Safety Mechanisms and Exceptions.
Research teams at institutions using Epic must not only contact ODQ, but also submit a helpdesk ticket to Research-PeC for any duplicate enrollment. Otherwise, subject registration information in Epic will not update.