Guidelines For OPEN Access and Crediting

OPEN System Access – Level 1

All persons accessing OPEN must have an active Investigator or Associate registration with the Cancer Therapy Evaluation Program (CTEP) and maintain a current CTEP-IAM account.

Persons viewing OPEN data must be aligned with an institution on an organization roster in RSS. This includes the CTSU roster, a Cooperative Group roster, or other network roster.

OPEN System Access – Level 2

OPEN access privileges (what the user is able to access upon entering the system) are based upon roles assigned to that person at their affiliated institutions. Roles include:

1)Site_Staff – user can view enrollment history at an institution but cannot enroll subjects at that institution.

2)Site Reg – user can view enrollment history at an institution and has enrollment privileges.

3)CTSU_Reg_ADMIN – limited to Cooperative Group and CTSU staff that have administrative rights to the system.

A user may hold multiple roles at a given institution and their roles may be different from institution to institution. For example, Joe Smith linked to site ALXXX may have Site_Staff role assigned for ECOG, but be assigned a Site_Reg role for CTSU.

OPEN System Access – Level 3

The ability to enroll subjects to a particular protocol is based upon the enrolling institution’s affiliation to the lead protocol organization and the assignment of the Site_Reg role, or its Cooperative Group equivalent, to the user at the enrolling institution.

For enrolling institutions that are members of the lead protocol organization the user must hold a Site_Reg role equivalent on the lead organization’s membership roster to enroll subjects.

For enrolling institutions that are not members of the lead protocol organization (and allowed to participate on the study) the user must hold a Site_Reg role on the CTSU roster.

Looking at the example above, assuming ALXXX is an ECOG member and Joe Smith wants to enroll a subject to an ECOG led study, he would not be allowed as he does not have the ECOG equivalent to the Site_Reg role on the ECOG roster at ALXXX. On the other hand, if Joe Smith wanted to enroll a patient to a SWOG led protocol on the CTSU menu he would be able to enroll the patient because he holds the Site_Reg role for CTSU at the site.

The table below outlines the specific group defined role the user must have to enroll subjects to their studies via OPEN.

SITE STAFF ROLE REQUIREMENTS
FOR PATIENT ENROLLMENT IN OPEN
Protocol Lead Group / Lead Group Member Role
NSABP / Must have ‘Treatment Patient Entry Privilege’ for a particular institution and site within Coordinator Online on the NSABP Members’ web site in order to enroll patients.
Please contact NSABP at for questions regarding your privileges to enter patients.
ACOSOG / Must be an active member on the ACOSOG Group roster in order to enroll patients.Please contact ACOSOG at or 919 668-8400 for questions regarding your roster status.
RTOG / Must have the role of ‘Site Registrar’ on the RTOG Group roster in order to enroll patients.
Please contact RTOG for questions regarding your roster status or call the Randomization Line @ 215-574-3191.
ECOG / Must have the role of ‘Site Registrar’ on the CTSU roster and be a member of ECOG in order to enroll patients.
Please contact ECOG at or call the Randomization Line @ 617 632-2022 for questions regarding your roster status.
NCCTG / Must have the role of ‘Site Registrar’ on the NCCTG Group roster in order to enroll patients.
Please contact NCCTG at or questions regarding your roster status.
SWOG / Must be an active member on the SWOG Group roster in order to enroll patients.
Please contact SWOG r 210 450-8808 for questions regarding your roster status.
CALGB / Must have the role of ‘Site Registrar’ on the CALGB Group roster in order to enroll patients.
Please contact CALGB for questions regarding your roster status.
GOG / Must have the role of ‘Site Registrar’ on the GOG Group roster in order to enroll patients.
Please contact GOG at or questions regarding your roster status.
NCIC / Canadian sites must enroll through NCIC.
Non-Lead Group or CTSU Member / Must have the role of ‘Site Registrar’ at the treating institution on the CTSU roster in order to enroll patients.
Contact CTSU Help Desk at 1 888 823-5923 or email if you have any questions. You may also view your role status via the Site Roles Screen under the RSS tab on the CTSU Members’ Web Site

Credentialing Rules:

The institution must have an “approved” status for the desired protocol for the user to be able to select the protocol in OPEN.

All enrollments must have an assigned Treating Investigator.

  • The Treating Investigator must hold an active Investigator Registration (IR) with CTEP
  • The Treating Investigator must be active on a Cooperative Group or CICRS treatment roster at the enrolling institution.

All enrollments must be assigned a Credit Investigator

  • The credit investigator must hold an active IR Registration with CTEP
  • The credit investigator must hold an active treatment affiliation with the credited organization at the enrolling site.
  • The system will default to the Treating Investigator when the treating investigator holds an active treatment affiliation with the credited organization at the enrolling site.

Assignment of other persons to an enrollment is based upon the person having an active Associate or IR registration and holding an active role on an organization roster at the enrolling site.

Crediting Rules – In order of priority

  • Canadian Institution participating on studies that are endorsed by NCIC CTG must credit NCIC CTG for the enrollment regardless of affiliation to the lead protocol group.
  • Institutions that are members of the Lead Protocol Group must credit the Lead Protocol Group.
  • Inter-group rule – institutions participating under a traditional inter-group arrangement must credit the “inter-group” participant.
  • Endorsement Plus - is defined as a process by which the Lead Cooperative Group for a specific study on the CTSU protocol menu (i.e., Lead Protocol Group) allows its institutions that hold dual membership with another Cooperative Group(s) to select either the Lead Group or the designated Endorsement Plus Group(s) to receive accrual credit for an enrollment to that study provided that the credited investigator is a member of the credited Group.
  • Institutions that are dual members of both the Lead Protocol Group and the Endorsing Plus Group(s) may credit either Group for enrollments.
  • Institutions that are members of the Endorsement Plus Group(s), but are not members of the Lead Protocol Group, may credit the Endorsement Plus Group(s) or any Group to which both the institution and enrolling investigators are members.
  • All other enrollments – may be credited to an organization participating on the study to which the institution and the credited investigator are active treatment members.
  • The crediting rules above apply to assignment of credit for the enrollment inclusive of responsibilities for accrual payments and ultimately audit. In some instances while the credited organization may participate on a study it will not give member institutions “membership credit” for enrollments to protocols in disease area in which they do not participate. Please check with your affiliated organization to verify for which disease areas they will provide membership credit.

October 3, 2018Page 1