chandramohan
●    

2006-05-26 21:51
(6516 d 01:17 ago)

Posting: # 140
Views: 8,405
 

 screening validity period [Design Issues]

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In case if the subject is found that erroneously included in the study after period 1, then subject has to be withdrawn from the study?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,
Chandramohan.
H_Rotter
★    

Germany,
2006-05-29 16:28
(6513 d 06:40 ago)

@ chandramohan
Posting: # 142
Views: 6,300
 

 screening validity period

Hi Chandramohan!

❝ Is there any guidelines stating that the validity period for the screening procedures is for about 21 days.


Hhm, I do not know any guideline in that respect.

❝ If no why to keep 21 days as a validity period by most of the BE centres.


Most CROs I know, keep the maximum at two weeks...

❝ If the volunteer erroneously included the study whose validity period is completed by a week, what action should be taken?


I do not understand your question.
What do you mean with 'validity period is completed by a week'? Do you mean that the maximum period was stated in the protocol with 21 days, and the subject was screened 28 days before the first treatment?

❝ In case if the subject is found that erroneously included in the study after period 1, then subject has to be withdrawn from the study?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.


IMHO if this case was not foreseen in the protocol, it's upon the investigator's destinction. I would opt for an intermediate screening (between treatment periods) to justify keeping the subject in the study.
Anyhow it's a protocol deviation, which should be discussed in the clinical study report (according to ICH E3):

10.2 PROTOCOL DEVIATIONS
All important deviations related to study inclusion or exclusion criteria, conduct of the trial, patient management or patient assessment should be described.
In the body of the text, protocol deviations should be appropriately summarised by centre and grouped into different categories, such as:
- those who entered the study even though they did not satisfy the entry criteria;
- those who developed withdrawal criteria during the study but were not withdrawn;
- those who received the wrong treatment or incorrect dose;
- those who received an excluded concomitant treatment.
In appendix 16.2.2, individual patients with these protocol deviations should be listed, broken down by centre for multicentre studies.


Best regards,
Hermann
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