HEADQUARTERS UPDATE

1
HEADQUARTERS UPDATE

• RA Committee
• February, 2007
• Stephen Dorian
• RTOG Director of Data Management, Clinical Trials

2
Case Registration

• PLEASE PRESS SUBMIT BUTTON ONLY ONCE
• Screen may show the Hour Glass for various
  reasons (e.g., your system or our system may be
  slow/overloaded)
• PLEASE JUST WAITDO NOT RE-PRESS SUBMIT
• You WILL receive your email confirmation

3
Web Data Collection Forms

• 9406 Prostate Follow-up
• 9408 Prostate Follow-up
• 9413 Prostate Follow-up
• 9601 Prostate Follow-up
• 9704 Pancreas Follow-up
• 9804 Breast Follow-up
• 9811 Anal Canal Follow-up
• 9910 Prostate Follow-up
• 0113 Esophagus Follow-up
• 0114 Gastric Follow-up
• 0126 Prostate Follow-up
• 0128 Cervix Follow-up
• 0129 Head/Neck Follow-up
• 0246 Esophagus Follow-up
• 0247 Rectal Follow-up
• 0319 Breast Follow-up
• 0417 Cervix Follow-up
• 0418 Pelvis Follow-up

• 0525 Study
• All forms (North America)
• AE Pages
• Will help us reconcile with AdEERS in real
  time
• I1 (Initial Evaluation/On-Study) Form
• Will be next for web data collection

4
Web Data Collection Forms

• Upon submitting web forms please remember to
  print your confirmatory E-mail
• You will receive your data as both Form Summary
  Data and a complete Data Form
• Form Summary Data contains only the data
  elements/sections with entered data
• Data Form contains all of the data
  elements/sections
• Please use the complete form (Data Form) for
  data revisions or, when applicable, please
  respond directly on Query form
• Question vs. Data Element
• QNO is referring to the Data Element (not
  Question)

5
Patient Status

• If the only information known is that the patient
  is alive or dead, we would still like this
  information for survival updates.
• This information should be communicated to HQ on
  an F1 form (not a general communication memo).
  Fill in any areas on the F1 form with known
  information. Complete the rest of the questions
  with unknowns.

6
Patient Status

• If patient status is unknown, do not send in an
  F1 form. Send in a general communication memo
  listing all attempts to locate the patient and
  request the F1 form be suppressed on the
  calendar.
• If the patient has not be located for 3 years,
  send a general communication memo documenting all
  attempts to locate the patient. Patient status
  will be changed to lost. Future F1s will be
  suppressed and a V5 will be added to the
  calendar. The V5 is a reminder to keep looking
  for the patient. If the patient is found, the
  calendar will be re-activated and the patient
  status updated.

7
AdEERS

• AdEERS Reporting, Questions, and Reconciliation
• PLEASE REMEMBER TO INITIATE AdEERS REPORT WITHIN
  24 HOURS OF BECOMING AWARE OF AN SAE
• Any questions about AdEERS reports please contact
  CTEP content or technical helpline (usually
  responds within a few hours)
• PLEASE REMEMBER TO RECONCILE AE CRF PAGE WITH
  AdEERS REPORT (and vice versa)
• CTCAE MedDRA 6.0 ? MedDRA 9.0
• Each study is coded using same AE dictionary
  version throughout study
• Seamless to institutions (same coding tool,
  different code numbers)

8
Withdrawal of Consent

• Submit CW form ONLY if patient withdrawals
  consent to participate in every portion of the
  study, including follow-up
• Please submit signed and dated form (patient,
  witness, PI)
• Withdrawing consent for any further participation
  in a study does not affect any data previously
  collected with the patients consent (per HIPPA,
  FDA, NCI, caBIG)

9
Calendar

• The new and improved Calendar OPS Tool is now
  available
• Your calendar will match HQs calendar
• Improving communication and problem solving
• You will be able to print out your own forms due
  report at any time
• For example, all forms due in 2006, all forms due
  by June, 2007
• Report can be filtered by study, case, form, and
  due date

10
Calendar

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11

Calendar
12
In-House RA Training

• In-house (RTOG, Philadelphia) RA training was
  initiated October 26 - 27, 2006
• Next scheduled in-house training will be held
  April 12 - 13, 2007
• Invaluable training for new Institutions and/or
  new RAs

13
Cancer Biomedical Informatics Grid (caBIG)

• caBIG Primer https//cabig.nci.nih.gov/overview/ca
  big-primer/
• Provides high-level overview for current, new,
  and prospective participants (e.g., programs
  vision and mission, organization, activities, and
  challenges)
• caBIG Overview
• Provides infrastructure for creating,
  communicating and sharing bioinformatics tools,
  data and research results, using shared data
  standards and shared data models
• There are many caBIG working groups you may want
  to participate in (e.g., standardized CRFs/DBs,
  AEs, patient calendars, tissue banking)
• If not already involved, please consider becoming
  involved (i.e., caBIG truly needs everyones
  involvement to be successful)

14
Thank you very much!

• Email sdorian_at_phila.acr.org
• Phone [phone]