Alliance membership is institutional and includes Main Members, Affiliates, LAPS Integrated Components, NCORP Components and Sub-Components, and Sub-Affiliates. Each membership type has specific application, approval, and roster requirements.
Who can apply for Alliance membership?
Alliance membership is available to organizations and research networks that participate in the NCI National Clinical Trials Network (NCTN) and meet applicable Alliance membership requirements. Depending on their organizational structure and relationship to the Alliance, applicants may include:
Main main members are institutions that participate directly in the Alliance as a primary member site.
Affiliates members are institutions that participate in the Alliance through an established relationship with a Main Member or other eligible member network.
LAPS (Lead Academic Participating Site) Integrated Components are participating sites or components that are integrated with a LAPS network, as designated by the National Cancer Institute. To become LAPS, sites had to demonstrate their ability to enroll high numbers of patients onto NCI National Clinical Trial Network (NCTN) trials, as well as scientific leadership in the design and conduct of clinical trials.
NCORP components and sub-components are community-based or other participating sites that are part of an NCI Community Oncology Research Program (NCORP) network.
Sub-affiliates are institutions or sites that participate through an existing Alliance member or network and have a defined relationship with the parent site.
How I apply for membership?
The application process and required documentation vary depending on the type of organization and its relationship to an existing Alliance member or network.
Organizations applying as a Main Member or Affiliate should:
- Review the Membership Application Instructions.
- Complete the appropriate Membership Application.
- Submit the completed application and all required supporting documentation according to the application instructions.
- The application will be reviewed through the Alliance membership approval process.
Sub-affiliates, LAPS integrated components, and NCORP components and sub-components complete an abbreviated application process, as applicable. The application should be accompanied by a letter from the Network Principal Investigator explaining the relationship between the sub-affiliate or sub-component and the parent site. Applications should be submitted through the appropriate system:
What happens after membership is approved?
Once membership is approved and the site is activated, individuals may be added to the institutional roster through CTSU RUMS or NCORP-SYS, as applicable. The appropriate institutional leadership roles should also be established, including the Principal Investigator and Lead Clinical Research Professional. Other roles, such as Co-Principal Investigator and Secondary Lead CRP, may be required or recommended depending on the membership type and site structure.
Individuals participating in NCTN activities must maintain the appropriate NCI registration, credentials, training, and other applicable requirements.
Institutional leadership roles and responsibilities
Each Alliance member institution or network should designate appropriate leadership roles to provide oversight, maintain communication with the Alliance, and support roster management.
The Network Principal Investigator (PI) provides overall oversight of the Alliance program across the member network, including affiliated sites. There may be one Network PI per network. A change in Network PI requires formal notification to the Alliance Membership Manager at Membership@AllianceNCTN.org, including documentation signed by the outgoing and incoming PIs and a CV or biosketch for the incoming PI.
The Network PI:
- Oversees Alliance activities across the network.
- Receives Alliance communications and performance information for sites within the network.
- Provides oversight of network performance and participation.
- Must be rostered at the Tier I site and assigned the PI role.
The Institutional PI is responsible for Alliance activities at the institution or site. Each site must have one PI assigned to the site. Depending on the organizational structure, the same individual may serve as both the Network PI and Institutional PI.
Responsibilities include:
- Providing overall oversight of Alliance activities
- Overseeing investigators and research staff involved in Alliance activities
- Supporting compliance with Alliance policies and procedures
- Ensuring appropriate oversight of Alliance clinical trial activities
The Co-PI serves as the PI’s designated backup and assumes PI responsibilities when the PI is unavailable for a significant period of time.
- A Co-PI is required for Tier I sites
- Tier II and Tier III sites may designate a Co-PI, but the role is not required
- There may be only one Co-PI per network or site
The Lead Clinical Research Professional (CRP) serves as the primary operational contact between the Alliance and the member network. The Lead CRP must be rostered at each site within the member network, including Tier I sites. There may be one Lead CRP per network. Changes to the Lead CRP role are processed through the Alliance Membership Manager at Membership@AllianceNCTN.org.
The Lead CRP:
- Receives and distributes Alliance communications and performance reports
- Serves as the primary contact for the network
- Manages institutional rosters through RUMS or NCORP-SYS, as applicable
- Supports the maintenance of accurate institutional and network rosters
- Ensures appropriate individuals are added to or removed from rosters
The Secondary Lead Clinical Research Professional (SL-CRP) serves as backup to the Lead CRP and helps ensure continuity of communication and roster management. When changing the SL-CRP, the existing role should be withdrawn before requesting the role for the replacement to help avoid processing delays. Each site should designate a Secondary Lead CRP.
The SL-CRP:
- Serves as backup to the Lead CRP
- Supports roster management and related responsibilities
- Helps maintain continuity when the Lead CRP is unavailable
- There may be one SL-CRP per site
- The same individual may serve as SL-CRP for multiple sites
- SL-CRP requests are submitted through RUMS and require Alliance roster approval
Roster and roster management
The Lead CRP and Secondary Lead CRP are authorized to manage roles for individuals already on the institution’s roster. Roster management depends on the type of member. The Lead CRP or SL-CRP may maintain roles for individuals already rostered through RUMS, subject to applicable Alliance approval requirements.
- For LAPS and Non-NCORP/Non-LAPS Members, the Lead CRP requests additions and withdrawals must be made through CTSU RUMS. Individuals serving in required lead roles cannot be withdrawn without a corresponding request to assign the role to another qualified individual.
- For NCORP Members, the NCORP administrator or designee manages roster additions, changes, and withdrawals through NCORP-SYS.
Institutional leaders and individuals participating in NCTN activities may be required to maintain specific NCI registrations, credentials, and training. These requirements are managed through NCI, CTEP, CTSU, and other external systems and are separate from the Alliance membership application process.
In general:
- PI/Co-PI: Must maintain the applicable Investigator registration in the NCI Registration and Credential Repository (RCR)
- Lead CRP/SL-CRP: Must maintain the applicable Associate Plus registration
- Individuals on NCTN rosters: Must maintain an active CTEP-IAM account and complete required annual registration
- Investigators and applicable research personnel: Must maintain required Human Subjects Protection and Good Clinical Practice training
To receive Alliance broadcast e-mails, the following leadership roles must be enabled for the following individuals:
- Principal Investigator
- Co-Principal Investigator
- Lead CRP
- Secondary Lead CRP
If you are not receiving Alliance broadcast e-mails:
- Check your junk or spam folder
- Confirm that you have not unsubscribed from Alliance communications
- Contact your institutional IT/IS department to confirm that Alliance emails are not being blocked
For assistance with Alliance communications, contact the Alliance Service Center at AllianceServiceCenter@AllianceNCTN.org.