2010-06-14_CTRP_Site_Presentation

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					NCI Clinical Trials Reporting Program
CTRP User Group

June 14, 2010
Agenda

• User engagement approach
• Account policy change
• Demo:
  – Create a new account
  – Organizational Access
  – XML On-demand
• AOB
           Informatics Technology and Adoption Timeline
         January              July               October              January               March                    June         September
           2009               2009                2009                  2010                 2010                    2010            2010
                         •    Pilot Cancer Centers:
                                –     New Trials (Jan 2009 – Jul 2009)
                                                                   New and existing                                                 Ongoing
                 New trials     –     New and existing trials, amendments (Jul 2009 – Jun 2010)
     Pilot                                                        trials, amendments                                              Registrations
                                –     Accruals Pilot (Jan 2010 – Apr 2010)
    Cancer
                                –     Ongoing Registrations (Jun 2010 and ongoing)
    Centers                                                                       Accruals
                         •    “Early Adopter” Cancer Centers                        Pilot
                                –     New trials, amendments (Jul 2009 – Oct 2009)
                                –     New and existing trials, amendments (Oct 2009 – Jun 2010)
“Early Adopter” Cancer
                                –     Ongoing Registrations (Jun 2010 and ongoing)and existing
                                     New trials,                            New                                                     Ongoing
        Centers
                         •         amendments
                              All Remaining Cancer Centers                 trials, amendments                                     Registrations
                                –     New trials, amendments (Oct 2009 – Jan 2010)
                                –     New and existing trials, amendments (Jan 2010 – Jun 2010)
    All Remaining
                                –                            (Jun trials,
                                      Ongoing RegistrationsNew 2010 and ongoing)         New and existing                           Ongoing
    Cancer Centers                                        amendments                   trials, amendments                         Registrations
                         •    Non-Cancer Center Grantees
                                –     New trials, amendments (Jan 2010 – Mar 2010)
   Non-Cancer                   –                                                   – July 2010)
                                      New and existing trials, amendments (Mar 2010New trials,                New and existing           Ongoing
  Center Grantees               –     Ongoing Registration (July 2010 and ongoing) amendments                trials, amendments        Registrations
                         •    All grantees
                                –     2011 – AEs, Outcomes, Non-interventional etc. (Jul 2010 and ongoing)
                                –     Accruals (Oct 2010 and ongoing)                                                                             Accruals

        All
      Grantees                                                                                                                    2011 – AE’s, Outcomes,
                                                                                                                                  Non-interventional, etc.
Release Timeline

• CTRP 3.2 planned features - July
   –   https://wiki.nci.nih.gov/display/CTRP/CTRP+3.2
   –   Organizational access
   –   Security changes
   –   XML On-demand
   –   CT.gov field optionality
   –   Add regulatory fields to the interface (already in the batch):
        • Oversight Authority Name and Country, FDA Regulatory
          Information (Yes/No), Section 801 (Yes/No), Delayed Posting
          (Yes/No), Data Monitoring Committee Appointed (Yes/No)
   – Partial save
Release Timeline

• CTRP 3.2 planned features – July
   –   Batch template supports IDs, no full record necessary
   –   Enhancements to system-generated emails
   –   PDF TSR
   –   Fix search
• CTRP 3.3 plans – Fall 2010
   – RSS integration for cooperative group trials
   – Batch accruals
• 2011 – AEs, Outcomes, Non-interventional studies
Account Change Process

• As part of CTRP 3.2, we are integrating CTRP's user
  account management with the caBIG®/caGrid user
  account management
• What this means for CTRP users:
     – New user name policy
            • User Name will no longer be email address
            • User Name will be between 4 and 15 characters

     – New password policy

 Password must be between 10 and 20 characters, cannot contain a dictionary word, and must contain at least
   one upper, one lowercase letter, at least one number, and at least one symbol (~!@#$%^&*()_++{}[]:;,>?)
Account Change Process

• Existing CTRP user accounts will be automatically
  migrated as part of the CTRP 3.2 rollout

   – This applies to anyone with a valid CTRP Registry user
     account as of 6/30/10
   – A new username will be created and sent to the email
     address listed for your existing account in Registry
   – A temporary password will be created and sent to the email
     listed for your existing account
   – Passwords can be reset by user at any time from within
     CTRP Registry account management page
   – User name cannot be reset by user
Account Migration Process

User Name: Last name + 1st letter of First name. If that user
   name is already taken, we will add a number to the end (for
   example, smithj will become smithj2)
2. Password: A new temp password will be created that
   conforms to the following: 10 character long with mixed upper
   case + lower case + numbers + special characters.
3. Address: If no address is associated with a user account, but
   an organization is listed, we will use the organization address.

Note: User accounts associated with an NIH LDAP email account
  will not be migrated as part of this process and will be treated
  separately.
Account Migration Timeline - Approximate

• Monday, July 12 (1 week prior to 3.2 release): A general
  email reminding users about upcoming release of 3.2 will be
  distributed via the CTRP users list with a reminder about the
  upcoming user account changes
• Monday, July 19 (1 day prior to 3.2 release): Email with new
  username will be sent to each existing user
• Monday, July 19 (1 day prior to 3.2 release): Email with
  temporary password sent to each existing user
• ETA - Tuesday, July 20: CTRP 3.2 Release Date

*IN ADDITION, anyone who runs into problems logging into 3.2 with the new user name
    and password will be able to get immediate help by sending email to the
    ncictrp@mail.nih.gov mailbox.
Demonstrations

• Account creation
• Organizational Access
• XML On-demand
CTRP User Resources

• CTRP User meeting minutes:
    https://wiki.nci.nih.gov/display/CTRP/CTRP+User+Meetings
• CTRP informational website: http://www.cancer.gov/ncictrp
     – Resources include FAQs, Glossary, and a CTRP User’s Guide
• CTRP Forum: https://cabig-
    kc.nci.nih.gov/CTMS/forums/viewforum.php?f=31
     – Ask questions of the CTRP team and other CTRP users
•   CTRP Developers’ wiki: https://wiki.nci.nih.gov/display/CTRP
•   CTRP-USERS-L@list.nih.gov – CTRP Users Listserv
•   NCICTRP@mail.nih.gov – Program questions
•   NCICTRO@mail.nih.gov – Clinical Trials Reporting Office

				
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