screening validity period [Design Issues]

posted by chandramohan – 2006-05-26 21:51 (6151 d 07:13 ago) – Posting: # 140
Views: 7,935

Dear all,

Is there any guidelines stating that the validity period for the screening procedures is for about 21 days. If no why to keep 21 days as a validity period by most of the BE centres.
If the volunteer erroneously included the study whose validity period is completed by a week, what action should be taken?
In case if the subject is found that erroneously included in the study after period 1, then subject has to be withdrawn from the study? or is it practical to do all lab test parameters and continue the subject in the study period 2 if all lab parameters found normal.

With regards,

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