1. NCI Clinical Trials Reporting Program CTRP User Group June 14, 2010

2. Agenda User engagement approach Account policy change Demo: –Create a new account –Organizational Access –XML On-demand AOB

3. Informatics Technology and Adoption Timeline Pilot Cancer Centers: –New Trials (Jan 2009 – Jul 2009) –New and existing trials, amendments (Jul 2009 – Jun 2010) –Accruals Pilot (Jan 2010 – Apr 2010) –Ongoing Registrations (Jun 2010 and ongoing) “Early Adopter” Cancer Centers –New trials, amendments (Jul 2009 – Oct 2009) –New and existing trials, amendments (Oct 2009 – Jun 2010) –Ongoing Registrations (Jun 2010 and ongoing) All Remaining Cancer Centers –New trials, amendments (Oct 2009 – Jan 2010) –New and existing trials, amendments (Jan 2010 – Jun 2010) –Ongoing Registrations (Jun 2010 and ongoing) Non-Cancer Center Grantees –New trials, amendments (Jan 2010 – Mar 2010) –New and existing trials, amendments (Mar 2010 – July 2010) –Ongoing Registration (July 2010 and ongoing) All grantees –2011 – AEs, Outcomes, Non-interventional etc. (Jul 2010 and ongoing) –Accruals (Oct 2010 and ongoing) New trials January 2009 October 2009 January 2010 July 2009 June 2010 Pilot Cancer Centers New and existing trials, amendments “Early Adopter” Cancer Centers New trials, amendments New and existing trials, amendments All Remaining Cancer Centers New trials, amendments New and existing trials, amendments Non-Cancer Center Grantees New and existing trials, amendments Accruals Pilot All Grantees Accruals 2011 – AE’s, Outcomes, Non-interventional, etc. March 2010 September 2010 Ongoing Registrations Ongoing Registrations Ongoing Registrations New trials, amendments Ongoing Registrations

4. Release Timeline CTRP 3.2 planned features - July –https://wiki.nci.nih.gov/display/CTRP/CTRP+3.2https://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

5. 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

6. 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 (~!@#$%^&*()_++{}[]:;,>?)

7. 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

8. Account Migration Process User Name : Last name + 1 st 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.

9. 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.

10. Demonstrations Account creation Organizational Access XML On-demand

11. CTRP User Resources CTRP User meeting minutes: https://wiki.nci.nih.gov/display/CTRP/CTRP+User+Meetings https://wiki.nci.nih.gov/display/CTRP/CTRP+User+Meetings CTRP informational website: http://www.cancer.gov/ncictrp 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 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’ wiki: https://wiki.nci.nih.gov/display/CTRP CTRP-USERS-L@list.nih.gov – CTRP Users ListservCTRP-USERS-L@list.nih.gov NCICTRP@mail.nih.gov – Program questionsNCICTRP@mail.nih.gov NCICTRO@mail.nih.gov – Clinical Trials Reporting OfficeNCICTRO@mail.nih.gov