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Long Term Follow Up Timeline caBIG

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					         Long Term Follow Up Timeline


*Off
                                                                          *Off
Treatment
                           Long Term Follow-Up                            Study




A subject’s Long Term Follow-Up is defined as the time period
between coming ‘Off treatment’ and coming ‘Off Study’.


 *, ** Next slide lists examples of ‘off treatment’ and ‘off study’ reasons
*Off Treatment Reasons      **Off Study Reasons
1) Adjuvant therapy         1) Death
2) Adverse event/toxicity   2) Patient lost to follow-up
3) Cytogenic resistance     3) Patient refused follow-up
4) Death on study           4) Progressive disease
5) Disease Progression      5) Follow-up completed
6) Lost to follow-up        6) Adverse event/toxicity
7) Subject ineligible
8) Subject withdrawal
9) Physician decision
10) Protocol violation
11) Treatment completed
     Long Term Follow-Up Procedures

1)   Procedures during Long Term Follow-Up are defined
     per protocol.

2)   These procedures vary from collecting survival data to
     completing CT scans and drawing blood for labs.

3)   Procedures are completed on a regular basis per protocol
     (i.e., every 3 months for 5 years)
              Example I
Regular Long-Term Follow-Up (Survival
                Data)


Research Coordinator contacts subject, or subject’s
health care provider, every three months during long-
term follow-up.
Data collected are:

• Date of Follow-Up
• Follow-Up conducted by: telephone, office visit, other
   – Document all that apply:
      • No changes from previous visit
      • Subject alive
      • Disease progression/relapse
          – Date of progression/relapse
• Subject death
   – Complete End of Study page
      » Date of last visit or contact
      » Check reason for End of Study
           Subject withdrew consent
           Lost to follow-up
           Death
           Date of death
           Cause of death
           Other
   – Was an autopsy performed?
Example II – Complex Long Term Follow-Up


This example has 8 years of long-term follow up
(protocol years 3-10).

The Research Coordinator schedules study visits to
complete the procedures per protocol.
              Protocol Years 3-5 :
      Long Term Follow-Up every 6 months


•   Assess survival and disease status
•   CBC w/differential, platelet count, TSH
•   Assess adverse events
•   Physical Exam
•   Assess ‘B’ symptoms
•   Repeat baseline radiology tests (i.e., CT scans)
             Protocol Years 6-10:
    Long Term Follow-Up Every 12 Months*

•   Assess survival and disease status
•   CBC w/differential, platelet count, TSH
•   Assess adverse events
•   Physical Exam
•   Assess ‘B’ symptoms
•   Repeat baseline radiology tests (i.e., CT scans)

*These are the same procedures as protocol years 3-5
                  Disease Progression
              During Long Term Follow-Up

If disease progression occurs, the same follow-up procedures
would be completed immediately as well as documentation of
the subject’s additional therapy (if any).

 Long Term Follow-Up Procedures
 • Assess survival and disease status
 • CBC w/differential, platelet count, TSH
 • Assess adverse events
 • Physical Exam
 • Assess ‘B’ symptoms
 • Repeat baseline radiology tests (i.e., CT scans)
 • Document additional therapy

				
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posted:10/14/2012
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