Participation and Crediting Rules
    Participation and Crediting Rules
National Clinical Trials Network (NCTN)

The NCTN consists of six Groups that generate trials for the Network.

Four adult U.S. Network Groups: The Alliance for Clinical Trials in Oncology; The ECOG-ACRIN Cancer Research Group; NRG Oncology and SWOG

One pediatric Network Group: The Children’s Oncology Group (COG)

One Canadian Network Group: The Canadian Cancer Trials Group (CCTG)

Member institutions of NCTN Groups may enroll patients on all adult phase 3 trials as well as select early phase trials, irrespective of the specific NCTN Group that is leading the trial. Select trials for adolescent and young adults will be open to all member institutions/sites.

NCTN Organization Chart
NCTN Organization Chart
1. Pre-approved for Main Member (non-accruing / administrative code) required for CTEP.


Participation Categories & Rules


Components
Sites are able to participate in one of three mutually exclusive ways (excluding pediatric sites). Sites may be members of multiple NCTN Groups with varying types of membership but the NCTN component must remain the same across all Groups.

 

Participation Rules for LAPS


LAPS grantees (Org type = LAPS) are administrative and cannot accrue subjects.
●  LAPS main member, affiliate, integrated component, and sub affiliate are enrolling sites that are part of the LAPS grant and are eligible for audit.

LAPS aligned affiliates and sub affiliates are enrolling sites that are not part of the LAPS grant and eligible for audit.

LAPS may be on multiple NCTN Group rosters and Groups must claim all sites within the LAPS grant.

The LAPS grant pays for enrollments by LAPS, unless otherwise specified.

The credited NCTN Group pays for enrollments by LAPS aligned affiliates and LAPS aligned sub affiliates, unless otherwise specified.

Participation Rules for Adult Network Groups

Main Member, Affiliate and sub affiliate sites are enrolling sites and are eligible for audit.

Sites can be on multiple NCTN rosters.

Main Member/Affiliate sites can participate in multiple ways across groups, but may only be claimed once by a group (e.g. Main Member for Group A, Affiliate for Group B).

The credited NCTN Group pays for enrollments, unless otherwise specified.

Participation Rules for NCORP/NCORP MU

NCORP grantees (Org Type = NCORP) are administrative and cannot accrue subjects but may be eligible for audit.

NCORP component, minority-underserved component, sub component and minority-underserved sub component sites are enrolling sites and are eligible for audit.

NCORPs may be on multiple NCTN Group rosters and Groups must claim all sites within the NCORP grant.

The NCORP grant pays for NCORP enrollments, unless otherwise specified.

Participation Rules for the Pediatric Network Children’s Oncology Group (COG)

Pediatric sites are main member accruing sites and are eligible for audit.

Pediatric sites may also be part of an Adult Network Group.

Pediatric sites must credit COG for enrollments.

Crediting Rules

US sites may credit any participating Network Group to which the site and credited investigator are affiliated and participating on the protocol.

Canadian sites must credit the NCTN Group that holds the CTA.

International sites must credit the Lead Protocol Organization (LPO) if they are a member of the LPO.

International sites that are not members of the LPO must receive approval from their credited group to participate and consistently credit the same group for the protocol.

    Adolescent and Young Adult (AYA) Trials

COG-led AYA trials open cross network for participation by all US Adult Network Groups:

COG investigators must credit COG with enrollments.

US Non-COG sites may credit any participating Network Group to which the site and credited investigator are affiliated and participating on the protocol.

CCTG sites may participate and credit CCTG only if the COG-led AYA trial is formally endorsed by CCTG.

NCTN AYA trials led by an Adult Network Group:

US sites may credit any participating Network Group to which the site and credited investigator are affiliated and participating on the protocol.

CCTG sites may participate and credit CCTG only if the trial is formally endorsed by CCTG.

Other Participating Sites or Networks on NCTN Trials

Occasionally other networks or sites outside of the NCTN are authorized to participate on NCTN trials. Sites participating outside of a network are termed non-member collaborators (NMCs) and must be listed on the protocol cover page along with the enrolling investigator at the site.  

NMCs will credit themselves for any enrollments

Other participating networks will credit their member network for enrollments.

Post Date: August 18, 2017