OPEN Conference Call with Groups Minutes by jolinmilioncherie


									                          OPEN- Conference Call with Groups - Minutes
                                                                                                        Version: 3/13/2008
Teleconference Information:
Date :                                           03/05/2008
Time:                                            1:00 pm EST
Phone #:                                         1-866-244-1377
Participant code:                                9377735 (#)
Host code:                                       4908519 (#)
For local participants:                          Westat Conference Room WB356

    ACOSOG       Sam Thomas
         CALGB   Charles Keen, Robert Dale
         ECOG    Susan Lemont, Bill Edwards
          GOG    Joe Jelonek
        NCCTG    Steven Groslie
   NCI/CTEP      Donna Shriner, Meg Mooney, George Redmond
  NCIC-CTG       Lam Pho
         NSABP   Mike Geier, Mimi Passarello
         RTOG    Wilma Hoffman, Hank Brasteter
         SWOG    Connie Barnes, Danna Sparks
         CTSU    Ravi Rajaram, Jerry Wernimont, Bill Niewood, Diana Meyer, Kasi Perumal, Brenda Rudd, Phoebe Whitefield,
                 Donna Marinucci, Ruth Lambersky, Martha Hering

Agenda Item I: Group Status PDF Document
Discussion Highlights
R. Rajaram stated that he would update the Group Status Document every 15 days, which will include
milestone updates. RTOG has submitted the plan. A development plan is needed from NCIC, NCCTG
and GOG. NCCTG has sent a plan internally; it will be available this week. L. Pho with NCIC stated that
the PR11 protocol would be used in OPEN, and that they are working on the development plan which will
be submitted by the end of the week. There was no reply from GOG. CALGB currently has a draft
development plan.
Action Items:
     -     Every fifteen days the milestones in the Group Status Document will be updated

     -     NCIC, NCCTG and GOG will send a development plan

     -     NCIC will send their development plan by the end of the week

Agenda Item II: Development Update
Discussion Highlights
NSABP, SWOG, ECOG and ACOSOG provided an update on their development status. M. Geier stated
that their system will be ready for processing the step 0 and step 1 registrations for B42 study. SWOG
has no development update, but has a baseline RandoNode and are looking at processing messages.
S. Lemont at ECOG stated that they have identified their second and third protocols to be implemented in
OPEN, E5103 and PACCT1, respectively. ECOG will be providing their RUMS pilot project details next

OPEN- Conference Call with Groups - Minutes                                                                      Page 1 of 3
0509cb49-7b78-498b-a7c0-e07200b4a0c0.doc                                                                        June 4, 2012
week. R. Rajaram explained that the updated form definition could be sent to the Groups through the
RandoNode, and it can be done for every version of the form. Metadata is sent separately from clinical
data. S. Thomas with ACOSOG indicated that they have the source code working, and they are ready to
have a form set up.

Action Items:
    -   SWOG will give a development update
    -   Expecting edit specifications and project plans from ECOG
    -   ACOSOG will set up RandoNode
    -   Set up form for ACOSOG

Agenda Item III: Enrollment Crediting
Discussion Highlights
M. Hering stated that there had been progress in regards to enrollment crediting during the discussions
on the crediting working group calls. There was a consensus among the groups that the endorsement
plus crediting scenario was the best option. This would allow the choice of credit to go to the lead group
or the endorsement plus group. It would be up to the group chair as to who the endorsement plus groups
would be. The challenge of implementing this method is how to collect the information, on an institution
based or institution/investigator based scenario. In other words, would the investigators be housed on
institutions or rosters, as sometimes it occurs that certain investigators are not on all rosters.

M. Hering described the following example scenario: a site is enrolling a patient on a GOG protocol, and
the site is on the GOG, ECOG, and SWOG roster. However, the investigator is not on the GOG group
roster. Based on the affiliation of the site and taking the investigator affiliation account, the site would not
be able to credit GOG. Since the investigator is not a member of GOG, the OPEN system would then
show an additional field for “crediting investigator”. Investigator not a member, add “crediting
investigator”. The rationale for this additional field is to collect accurate drug shipment information, the
name of the treating investigator, and the crediting investigator. This would be very helpful for regulatory
purposes. In addition, this will accommodate scenarios in which sites wish to record a different enrolling
and treating investigator; it will allow the system to record both parties and give credit to the desired
cooperative group.

J. Wernimont stated that the requirement of the treating investigator follows the established lead group
rule; the option to credit is filtered, based on the lead group and endorsement plus rule. He stated that if
the treating investigator is a member of the credited group, the registration will proceed as it is currently
done. However, if the treating investigator is not a member of the credited group, then OPEN will show
an option for crediting investigator, the user will be free to select an extra investigator. M. Hering stated
that this does not change the current rules, nor does it change the new endorsement plus rules. This
system will reduce the need for proxy investigators used solely for crediting preferences, and also will
reduce the need for overrides due to the fact that the treating investigator is not a member of the credited

D. Sparks with SWOG agreed that this was the most reasonable solution available, however she
expressed concern about the registering investigator being equated to the treating investigator. She
stated for SWOG studies that credit SWOG, they do not want to have a treating investigator that was not
a SWOG member. D. Sparks stated that SWOG is certain of their investigators and would not want any
other scenarios, because SWOG is responsible for the investigator.

W. Hoffman with RTOG inquired about cases in which investigators had stringent credentialing rules, and
about how this information was tracked. M. Hering replied that in these situations, such as the

OPEN- Conference Call with Groups - Minutes                                                          Page 2 of 3
0509cb49-7b78-498b-a7c0-e07200b4a0c0.doc                                                   6/4/2012 11:46:00 AM
Form_Name       requirement that an investigator is certified in particular technologies, the OPEN system would verify that
                the treating investigator was certified and met all qualifications. All investigators, including treating and
                enrolling investigators, must follow the 1572 requirements and be an active member of a cooperative
                group roster.

                D. Sparks mentioned the possibility of auditing problems due to the collection of two investigators. J.
                Wernimont replied that the credited investigator resumes responsibility for the enrollment. D. Marinucci
                stated that the current rules are concrete, and the OPEN system will allow one to look at more attributes.
                D. Sparks stated that SWOG does not agree with the lead group rule. M. Mooney responded that the
                crediting problem was presented multiple times to all cooperative groups, and that the group chairs voted
                to continue the endorsement plus rules. D. Sparks requested and exception for SWOG. M. Mooney
                answered that they cannot allow individual groups to make their own crediting rules. She went on to
                state that the group chairs agreed, and through this system you can see who is responsible, you would
                have the crediting and treating investigator listed, and in addition both investigators will be checked. J.
                Wernimont suggested a follow up with the crediting investigator, and to reiterate the policy to sites, post-
                enrollment, as this is a rare situation anyway. M. Mooney said many have dual membership intergroup
                trials, and was concerned that some investigators would be blocked out from registration.

                M. Hering summarized the following benefits of collecting both the treating and enrolling investigator as
                needed: 1) the sites will no longer be giving a proxy investigator solely to meet the crediting rules, 2) the
                information will supply us with the frequency of using two investigators for crediting purposes, 3) by
                analyzing the data, we may gain valuable information that may result in potential changes to the crediting
                rules. M. Mooney stated that from the registration perspective, we need to know exactly who is treating
                the patient, as well as who is giving the investigational agent.

                M. Mooney said that the crediting investigator must take all responsibility for the registration; she
                suggesting a note or an email goes to the crediting investigator and cooperative group. Trini suggested
                posting a warning during the registration process in OPEN that would state the implications of crediting.
                J. Wernimont replied that this wording could be included. D. Marninucci added that these multiple
                investigator problems already happens, and that this is the first time we are actually checking the status
                of both investigators, this was not checked in the past. M. Hering argued that this may slow down the
                registration process. Jerry mentioned adding notification to the investigators involved in the registration.
                M. Hering suggested in order to avoid “investigator shopping”, perhaps not use an investigator pull down
                menu, but force the site to enter the investigator name manually. Another option would be to always have
                a site use the same investigator. J. Wernimont made a suggestion that every group could decide who
                can be in their investigator drop-down menu.

                Action Items:
                    -   Discuss enrollment crediting on next cooperative group call

                Next call April 2 @1 PM

                OPEN- Conference Call with Groups - Minutes                                                        Page 3 of 3
                0509cb49-7b78-498b-a7c0-e07200b4a0c0.doc                                                 6/4/2012 11:46:00 AM

To top