Unscheduled visits and epoch user cases
This presentation is the property of its rightful owner.
Sponsored Links
1 / 8

Unscheduled Visits and Epoch. User Cases PowerPoint PPT Presentation


  • 56 Views
  • Uploaded on
  • Presentation posted in: General

Unscheduled Visits and Epoch. User Cases. UC1: Complications Related to How to Slot Partial/Missing Dates (CV). LB. EG. SV. UC2: Complications Related to Same Date (CV). LB. EG. Important to differentiate from same date planned visit?. SV. Combined SVUPDES?.

Download Presentation

Unscheduled Visits and Epoch. User Cases

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Unscheduled visits and epoch user cases

Unscheduled Visits and Epoch. User Cases


Uc1 complications related to how to slot partial missing dates cv

UC1: Complications Related to How to Slot Partial/Missing Dates (CV)

LB

EG

SV


Uc2 complications related to same date cv

UC2: Complications Related to Same Date (CV)

LB

EG

Important to differentiate from same date planned visit?

SV

Combined SVUPDES?


Uc3 complications related to unscheduled performed instead scheduled tk

UC3: Complications Related to Unscheduled performed instead scheduled (TK)

Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed

LB

Is it still unscheduled visit?

SV


Uc4 example partial date problem assigning epoch using dates cv

UC4: Example Partial Date Problem Assigning Epoch Using Dates (CV)

SE

Could have started during screening or open label treat. Choose treatment EPOCH

CM

Unknown. Could have started during open label treat, washout, blinded treat, or follow-up


Uc5 assigning of epoch after treatment discontinuation ns

UC5:Assigning of Epoch after treatment discontinuation (NS)

Study epochs per protocol:

Randomization

Treatment start

End of treatment,

Date of last trt

End of study, consent withdraw


Uc5 cont subject information

UC5: (cont.) subject information

  • CRF pages: end of treatment, FU, end of study

  • Subject has got 2 cycles. Last TRTDTC=2014-02-01

  • Cycle 3 should start at 2014-02-21, but subject has AE, thus treatment delay,

  • No bettering after 14 days, Lab visit, EG Visit performed. => Physician decision to discontinue treatment

  • Subject comes to visit and decide not to go to FU, but to withdraw consent at 2014-03-14, so no FU observation and data collection, end of study.

  • Q: Which epoch and VISITNUM to assign to LB and EG visit in delay period?


Uc5 cont subject time axis

UC5(cont.) Subject time axis

No FU information collected in Original EDC DB

Last treatment

2014-02-01

Consent W.

2014-03-14

LB and EG visit

Randomization

Treatment start

End of treatment,

Date of last trt

End of study, consent withdraw


  • Login